MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Fever (1858); Swelling (2091); Urinary Tract Infection (2120); Chills (2191); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)

Event Date 11/04/2017

Event Type  Injury  

Event Description

Immobilized; walking difficulty [mobility decreased], septic arthritis of right knee [arthritis septic], adverse event nos [adverse event nos], moderate ecchymosis left knee [ecchymosis injection site], total bilirubin increased [bilirubin increased], red blood cell count decreased [red blood cell count decreased], mean corpuscular volume increased [mean corpuscular volume increased], mean cell hemoglobin increased [mean cell hemoglobin increased], neutrophil percentage increased [neutrophil percentage increased], lymphocyte percentage decreased [lymphocyte percentage decreased], lymphocyte count decreased [lymphocyte count decreased], platelet count decreased [platelet count decreased], serum potassium decreased [serum potassium decreased], blood urea nitrogen increased [blood urea nitrogen increased], edema right knee [edema knees], stress right knee [stiff knees], knee effusion [effusion (r) knee], pain in right knee [pain in knee], swelling in right knee [swelling of r knee].Case narrative: based on the information received on 11-sep-2018 the case became medically confirmed.Upon internal review on 11-sep-2018 the case upgraded from non-valid to valid as new events were added.Initial information received on 09-aug-2018 and 15-aug-2018 was processed together regarding an unsolicited serious legal case from united states received from a consumer.This case involves a (b)(6) male patient who experienced septic arthritis of right knee, adverse event nos, immobilized, moderate ecchymosis left knee, pain in right knee, swelling in right knee, edema right knee, stress right knee and knee effusion (latency: unknown), total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased (latency: 3 days) while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The past medical history included arthritis on (b)(6) 2017, atrial fibrillation on (b)(6) 2017, heart rate abnormal, hypertension, spinal column stenosis, hypoacusis, peripheral swelling, cardiac pacemaker insertion with surgical history, hypersensitivity with codeine, cardiac failure on (b)(6) 2017, sleep apnoea syndrome on (b)(6) 2017, gastrooesophageal reflux disease on (b)(6) 2017, seizure, migraine, back problems, kidney stone, nephrolithiasis and arthritis.The patient's concurrent conditions included at the time of the event, the patient had ongoing tendonitis in 2018.The was a non-tobacco user and abstained from alcohol at the time of this report.Surgical history included cholecystectomy (gall bladder removed), patellectomy, appendicectomy, rotator cuff repair, knee arthroplasty, orthopedic surgeries.The past medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included meloxicam (meloxicam); amlodipine besylate (amlodipine besylate); aspirin acetylsalicylic acid] (aspirin); ondansetron, piperacillin sodium, tazobactam sodium (zosyn), cyanocobalamin (cyanocobalamin); fish oil (omega 3 fish oils); rivaroxaban (rivaroxaban); trazodone hcl (trazodone hcl); levetiracetam (levetiracetam); calcium carbonate, cholecalciferol (calcium carbonate with d3); ubidecarenone (ubidecarenone); ezetimibe (ezetimibe); primidone (primidone); methocarbamol (methocarbamol); spironolactone (spironolactone); valsartan (valsartan); omeprazole (prilosec), bisoprolol fumarate (bisoprolol fumarate); furosemide (furosemide); clonazepam (clonazepam); glycopyrrolate (glycopyrrolate); oxycodone (oxycodone); betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, cholecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); and hydrochlorothiazide (hydrochlorothiazide).On (b)(6) 2017, the patient received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown dose once (lot - unknown) for arthritis.On an unknown date in 2017, the patient developed septic arthritis of right knee (arthritis bacterial).On (b)(6) "2018" after a latency of 3 days (b)(6).This event was leading to intervention.The patient was hospitalized for this event, adverse event nos, was immobilized (mobility decreased), had moderate ecchymosis left knee, pain in right knee (arthralgia), swelling in right knee (joint swelling), edema right knee (oedema peripheral), stress right knee (joint stiffness) and knee effusion (joint effusion).On (b)(6) 2017, relevant laboratory test results included (b)(6).On (b)(6) 2017 labs included: blood glucose 134 mg/dl [high], carbon dioxide increased 32 mg/dl [high]; mean cell haemoglobin 34.6 pg [high].On (b)(6) 2017, labs were (b)(6); on (b)(6)2017, labs were (b)(6).The patient was put on 6-week iv antibiotic therapy.A surgery was performed to correct septic arthritis.The patient was using a rolling walker for ambulation.On (b)(6) 2017, the patient reported no falls, good appetite and normal bowel movements.The surgical wound was dressed on regular basis.The patient tolerated the whole procedure well.Final diagnosis was knee effusion, swelling in right knee, pain in right knee, adverse event nos, septic arthritis of right knee, immobilized, stress right knee, edema right knee and moderate ecchymosis left knee.Corrective: vancomycin (vancomycin) for arthritis bacterial and ceftriaxone (ceftriaxone) and surgical procedure for arthritis bacterial.Use of rolling walker for immobilized; walking difficulty outcome: not recovered for total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased; unknown for all events.Seriousness criteria: hospitalization and intervention required for arthritis bacteria; disability for mobility decreased.A product technical complaint (ptc) was initiated on 22-aug-2018 for synvisc.Batch number unknown, global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was 22-aug-2018.No safety issues were indicated in this review.Additional information was received on 22-aug-2018 in the form of investigation summary.Ptc results and number were added.Additional information was received on 11-sep-2018 from healthcare professional.Events of total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased was added.Medical history and concomitant medication was added.Clinical course was updated and text amended accordingly.

Event Description

Immobilized; walking difficulty [mobility decreased].Slow cadence [walking difficulty] ([pain upon movement]).Septic arthritis of right knee [arthritis septic] ([staphylococcal infection]).Hearing loss was worse after the antibiotic treatment [hearing loss bilateral].([condition aggravated]).Total bilirubin increased [bilirubin increased].Red blood cell count decreased [red blood cell count decreased].Mean corpuscular volume increased [mean corpuscular volume increased].Mean cell hemoglobin increased [mean cell hemoglobin increased].Neutrophil percentage increased [neutrophil percentage increased].Lymphocyte percentage decreased [lymphocyte percentage decreased].Lymphocyte count decreased [lymphocyte count decreased].Platelet count decreased [platelet count decreased].Serum potassium decreased [serum potassium decreased].Blood urea nitrogen increased [blood urea nitrogen increased].Elevated d-dimer [fibrin d dimer increased].Swelling in both legs [swelling of legs].Urinary tract infection [urinary tract infection].Edema right knee/ fluctuating knee edema/edema left knee [edema knees].Unable to control bladder [loss of bladder sensation].Fever [fever].Chills [chills].Dark urine [urine discoloration].Effusion of left elbow [effusion of elbow].Moderate ecchymasis left knee/ecchymosis left distal hamstring/popliteal fossa [ecchymosis injection site].Pain in right knee/tenderness anterior knee/arthritic pain right knee [pain in knee] ([pain upon movement]).Swelling in right knee/swollen to size of volleyball [swelling of r knee].Knee effusion [effusion (r) knee].Stress right knee [stiff knees].Rt knee red [injection site joint redness].Heat [joint warmth].Case narrative: based on the information received on 11-sep-2018 the case became medically confirmed.Upon internal review the case upgraded from non-valid to valid as new events were added.Initial information received on 09-aug-2018 and 15-aug-2018 was processed together regarding an unsolicited serious legal case from united states received from a lawyer.This case involves a 67 years old male patient who experienced septic arthritis of right knee, immobilized, moderate ecchymasis left knee/ecchymosis left distal hamstring/popliteal fossa, pain in right knee/tenderness anterior knee/arthritic pain right knee, swelling in right knee/swollen to size of volleyball, rt knee red, edema right knee/ fluctuating knee edema/ edema left knee, stress right knee and knee effusion (latency: unknown), total bilirubin increased, red blood cell count decreased, heat, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased (latency: 3 days), swelling in both legs, effusion of left elbow and elevated d-dimer (latency: unknown), fever, chills, dark urine, unable to control bladder, urinary tract infection, hearing loss was worse after the antibiotic treatment, slow cadence (latency: unknown) while he was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc) and vancomycin.The past medical history included right eye red, mva (motor vehicle accident), bilateral knee flexion limited, increased cholesterol, depression, stress fractures (possible at third metatarsal), wheelchair user, left foot problem/pain, diffuse edema in foot, gout in his heels, peroneus longus tendon repair due to rupture (sesamoid fracture adjacent to the cuboid), walking aid user (crutches), patellectomy, foot inversion injury on (b)(6)2003, stroke, bladder problems, popping sensation in elbow (once a day when he reaches full extension), memory loss, convulsions, impairment of balance, hearing loss, sexual dysfunction, hypersomnolence, abnormal heart rhythm, spinal stenosis, decreased hearing, feet swelling, on (b)(6) 2003 dexa scan which revealed no significant evidence of osteopenia or osteoporosis, cardiac pacemaker insertion on (b)(6) 2014, seizure (last episode on (b)(6) 2013), hypersensitive heart disease with heart failure on (b)(6) 2017, obstructive sleep apnea from on (b)(6) 2017 (patient was wearing (positive airway pressure) pap every night), gastrooesophageal reflux disease without esophagitis on (b)(6) 2017migraine, back problems, kidney stone, osteoporosis, head pain, head collision, lower bilateral extremities pain, fell added.Family history of hypertension, heart disease, stroke, copd and arthritis joint, cardiomyopathy, pneumonia, pneumonia (trouble with short and long term memory), tremors, trouble with balance/gait, shuffling feet, intermittent headache, shortness of breath, large hematoma of left arm bicep, change in vision, thoracic spondylosis right groin pain, bilateral renal cysts (including large cyst in right kidney measuring up to 10.7 cm), flu shot in oct-2017, patient's temperature that night it was 100.Patient got a shot of rocephin and levaquin.Patient also had fevers to 101 and continued to get worse.The patient's concurrent conditions included at the time of the event, the patient had ongoing elbow tendonitis in 2018, chronic atrial fibrillation, hypertension, fentanyl allergy, chronic peroneal tendon synovitis, chronic pain to neck, chronic pain to lower back, chronic pain to rt shoulder , varicose veins for which symptoms include mild edema and some leg pain, aggravated by prolonged standing, chest pain, chronic fatigue, daytime somnolence, hyperlipidemia, right leg with painful varicose veins, allergy with codeine, allergy to norco, allergy to pravastatin sodium and atorvastatin calcium with side effect of myalgias, sinusitis, drug allergy, vocal cord surgery, cataract removal, dizziness, vestibular neuronitis, congestion for left ear, fever, vertigo, decrease in hearing, abrasion of right ear canal, sensorineural hearing loss, hearing aid, superficial mycosis, nasal congestion, allergic rhinitis, dysphagia, throat pain, swelling, mass or lump in head and neck, acute upper respiratory infections of unspecified site, difficulty talking.The patient was a non-tobacco user and abstained from alcohol at the time of this report.Surgical history included patellectomy (1975) left ankle surgery (on (b)(6) 2003), cholecystectomy (gall bladder removed), total knee arthroplasty on (b)(6) 2005, patellectomy, appendectomy, rotator cuff repair, knee replacement, orthopedic surgeries, shoulder surgery bilaterally, eye surgery, bil rotator cuff, left foot surgery, cardioversion in jun-2014, heart catheterization on (b)(6) 2014, right heart catheterization with on (b)(6) 2017, knee surgery on (b)(6) 2017 and fiberoptic laryngoscopy.Patient's mother, two sisters and brother had history of coronary artery disease.His mother had heart attack and heart condition and his sibling had lung disease, sleep apnea/ snoring, depression, smoking, cancer.Father had history of kidney failure, two sisters and brother also had history of osteopenia, hypertension, heart disease, stroke, copd.Concomitant medications included meloxicam; amlodipine besylate (amlodipine besylate); aacetylsalicylic acid (aspirin); ondansetron, oseltamivir, piperacillin sodium, tazobactam sodium (zosyn), cyanocobalamin (cyanocobalamin); fish oil (omega 3 fish oils); rivaroxaban (xarelto); trazodone hcl (trazodone hcl); levetiracetam (levetiracetam); calcium carbonate, colecalciferol (calcium carbonate with d3); ubidecarenone; ezetimibe (zetia); primidone; methocarbamol; spironolactone; valsartan (valsartan); omeprazole (prilosec), bisoprolol fumarate; furosemide (lasix); clonazepam; glycopyrrolate; oxycodone; betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); and hydrochlorothiazide, amlodipine besilate (norvasc), levetiracetam (keppra), trazodone hydrochloride (desryl), meloxicam (mobic), fish oil, testosterone cipionate ,potassium chloride, nystatin, fluticasone propionate, glycopyrronium bromide (robinul), ciprofloxacin hydrochloride, vitamin b12, escitalopram oxalate (lexapro) and nebivolol hydrochloride (bystolic) on (b)(6) 2017, the patient received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown dose once (lot - unknown) for arthritis.There will be no information available on the batch number for this case.On an unknown date in 2017, the patient developed septic arthritis of right knee (arthritis bacterial) and was treated with 6 weeks of vancomycin (dose, form, route, frequency: not provided).The patient reported that after the injection his right knee was swollen to the size of a volleyball and his rt knee red (latency: unknown) and heat (latency: unknown).It was reported that the patient had a staph infection of right knee and had knee replacement surgery.On (b)(6) 2017 after a latency of 3 days total bilirubin was 1.9 mg/dl, red blood cell count was 4.49x10e6/ml, mean corpuscular volume was 101.2 fl, mean cell hemoglobin was 35.2 %, neutrophil percentage was 75.5%, lymphocyte percentage was 13%, lymphocyte count was 0.70x10e3/ul, platelet count was 118x10e3/ul, serum potassium was 3.4mmol/l and blood urea nitrogen was 22mg/dl.This event was leading to intervention.On the same day, patient was diagnosed with septic arthritis of right knee.The patient was hospitalized for this event, adverse event nos, was immobilized (mobility decreased), had moderate ecchymasis left knee, pain in right knee (arthralgia), swelling in right knee (joint swelling), edema right knee (oedema peripheral), stress right knee (joint stiffness) and knee effusion (joint effusion).On (b)(6) 2017, relevant laboratory test results included blood albumin 3.4 g/dl [low], blood bilirubin 1.9 mg/dl [high], lymphocyte percentage decreased 13 % [low], blood potassium 3.2 mmol/l [low], carbon dioxide increased 32 mg/dl [high], neutrophil percentage increased 75.5 % [high], platelet count decreased 126 10*3/ml [low], mean cell volume 99.5 fl [high], red blood cell count decreased 4.45 10*6/ml [low]; on (b)(6) 2017 labs included: blood glucose 134 mg/dl [high], carbon dioxide increased 32 mg/dl [high]; mean cell haemoglobin 34.6 pg [high].On (b)(6) 2017, the patient reported no falls, good appetite and normal bowel movements.On (b)(6) 2017, patient reported to the clinic for follow up of his chronic pain to neck, lower back and rt shoulder and rated it 5 on a scale of 10.He stated that his pain aggravated upon bending, lifting, prolong sitting and standing.Patient mentioned that he had constant aching radiating lower back pain, which was more on the right and extended till his feet.As a corrective for the same, patient took oxycodone and robaxin.On (b)(6) 2017, labs were blood urea 24 mg/dl, mean cell haemoglobin 34.6 pg [high], platelet count decreased was 146 10*3/ml [low]; red blood cell count decreased 4.6 10*6/ml [low], white blood cell count decreased 4.6 10*3/ml [low].The patient was put on 6-week iv antibiotic therapy.On (b)(6) 2017, labs were blood urea was 23 mg/dl [high]; carbon dioxide was 33 mg/dl [high], creatinine urine was 1.24 mg/dl [high], glomerular filtration rate 58 ml/min [low]; hematocrit was 41.8 % [low].A surgery was performed to correct septic arthritis.The patient was using a rolling walker for ambulation.The surgical wound was dressed on regular basis.The patient tolerated the whole procedure well.Patient had to use brace.On (b)(6) 2018, patient was unable to control bladder (latency: 3 months 27 days).On (b)(6) 2018, patient developed a fever (latency: 4 months) of 102 at night.On (b)(6) 2018, patient reported to the clinic with complaints of chills (latency: 4 months 1 day) and dark urine (latency: 4 months 1 day).Further, urine analysis of the patient was performed which confirmed urinary tract infection (latency: 4 months 1 day) and patient was prescribed rocephin, cipro and pyridium as a corrective for it.Further, the patient was advised to increase intake of oral fluids and to follow up if his condition worsened.On (b)(6) 2018, patient reported again for follow up of his chronic pain to neck, lower back and rt shoulder and rate it 6 on a scale of 10.The patient stated that his pain continued to hurt daily.On (b)(6) 2018, patient reported issues with swelling of both legs and effusion of right elbow (onset and latency: unknown).On (b)(6) 2018, patient reported for follow up of his chronic pain and stated that his pain continues to be radiating and constant and he was doing well with the decrease in his oxycodone.On (b)(6) 2018, patient was reported to have elevated d-dimer, shortness of breath and nuclear medicine ventilation/perfusion lung scan showed low probability of acute pulmonary embolus.On (b)(6) 2018, patient reported to the clinic for follow up of his chronic pain in his lower back.The patient was using a cane for walking assistance and described it as intermittent sharp and radiating into his posterior left lower extremity, extending occasionally to his knee and foot.On (b)(6) 2018, patient returned to the clinic for follow up of his chronic pain to lower back.He reported his pain was radiating to right leg, knee and foot and he was still using a cane for walking assistance.His pain was intermittent and sharp and was now shifting to his right leg.Furrther, upon examination, he had effusion in and around his right knee.On (b)(6) 2019, patient went for evaluation of hearing loss.It was reported that the hearing loss was worse after the antibiotic treatment (onset date: unknown).Also reported that patient's post vancomycin audiogram had worsened as compared to the pre-vancomycin audiogram.Patient was also wearing bilateral hearing aids.On the same day, patient's speech audiometry results were right (ad): 55 dbhl and left ad: 50 dbhl compared to the audiogram of on (b)(6) 2016 (right ear: 68% and left ear at 76% at 80 db).Patient was also offered to visit cochlear transplant surgeon.On (b)(6) 2018, patient went to healthcare facility and some observation were made regarding him that he lifted his leg and felt pop with increased pain.He was also diagnosed with slow cadence and ambulating with assistance.He was also diagnosed with tenderness in anterior knee and fluctuating knee edema.On (b)(6) 2018, patient showed that he ad tolerated pain well.On (b)(6) 2018, it was observed that his balance strength increased.On the evaluation on (b)(6) 2018, minimal edema was observed in the right knee.Patient had been aggressive in quadriceps exercises.On (b)(6) 2018, patient increased quadricep exercise and had 0/10 knee pain.On (b)(6) 2018, it was reported that patient had 5/10 right knee pain after doing wall slides.On (b)(6) 2018, patient had significant edema in the left knee localized to joint capsule.On (b)(6)2018, patient had severe ecchymosis left distal hamstring/ popiteal fossa.On (b)(6) 2018, it was noted to increase quadriceps and balance exercises.On (b)(6) 2018, it was reported that patient was doing well.On (b)(6) 2018, it was reported that his balance was improved with gait.On (b)(6) 2018, it was reported that patient had good effort with exercises.On (b)(6) 2018, it was reported that his balance was improved with gait.On (b)(6) 2018, it was reported that he had 4/10 bilateral knee pain ambulating while extended distance.On (b)(6) 2018, he was advised to consult with medical doctor in fluctuating pain/edema.On (b)(6) 2018, it was reported that his balance with gait was improved and quadricep exercises were increased.On the evaluation of on (b)(6) 2018, it was observed that there was decreased in right knee edema.On (b)(6) 2019, it was reported that patient was doing well.On (b)(6) 2019, it was reported that patient had right knee pain with standing.On (b)(6) 2019, it was reported that he had first arthritic pain right knee and he was frustrated by continuous pain.On (b)(6) 2019, it was reported that patient was having good efforts with quadriceps exercise and reported knee pain in last 2-3 days.On (b)(6) 2019, it was reported that patient was having increased resistance with quadriceps strengthening.On (b)(6)2019, it was reported that patient's quadricep balance was increased and good tolerance.On (b)(6) 2019, it was reported that patient had fluid gait with quadriceps.He was having fluctuating pain with gait.On (b)(6) 2019, he was improved with strength and balance.On (b)(6) 2019, it was evaluated that he was having 3/10 pain.Action taken for vancomycin was unknown.Corrective: vancomycin (vancomycin) for arthritis bacterial and ceftriaxone (ceftriaxone) and total knee replacement for arthritis bacterial and staph infection of right knee.Use of rolling walker for immobilized; walking difficulty; not reported for swelling in both legs, effusion of left elbow and elevated d-dimer; rocephin, cipro and pyridium for urinary tract infection; not reported for rest.Outcome: not recovered for hearing loss was worse after the antibiotic treatment, total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased; pain in right knee/tenderness anterior knee/arthritic pain right knee; recovering for slow cadence, edema right knee/ fluctuating knee edema/edema left knee and unknown for rest of the events.Seriousness criteria: hospitalization, medically significant and intervention required for septic arthritis of right knee; disability for immobilized, slow cadence; walking difficulty; disability and medically significant for hearing loss was worse after the antibiotic treatment.A product technical complaint (ptc) was initiated on 22-aug-2018 for synvisc.Batch number unknown, global ptc number: 55125.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was 22-aug-2018.No safety issues were indicated in this review.Additional information was received on 22-aug-2018 in the form of investigation summary.Ptc results and number were added.Additional information was received on 11-sep-2018 from healthcare professional.Events of total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased was added.Medical history and concomitant medication was added.Clinical course was updated and text amended accordingly.Additional information was received on 06-dec-2018 from lawyer.Medical history updated.Concomitant medications updated.Events of swelling in both legs, effusion of left elbow and elevated d-dimer were added with details.Follow up information received on 13-dec-2018.No new information.Additional information received on 11-jan-2019 from the lawyer.Therapy onset dates for concomitant medications updated.Concomitant medication nystatin was added.Clinical course updated and text amended accordingly.Additional information received on 14-jan-2019 and 16-jan-2019 (both the information was processed together with clock start date 14-jan-2019) from lawyer.Medical history was updated.Additional symptom of staph infection of right knee was added along with details.The event of adverse event nos was deleted from the case.Clinical course updated and text amended accordingly.Follow up information received on 24-jan-2019 and 25-jan-2019 from lawyer.No new information.Additional information was received on 30-jan-2019 from lawyer.Medical history was updated.Clinical course updated.Text amended accordingly.Additional information received on 11-feb-2019 from lawyer.Medical history of wheelchair user, right eye red, increased cholesterol, depression added.Surgical history of bil rotator cuff added.Concomitant medication of oseltamivir added.Events of fever, chills, dark urine, unable to control bladder, urinary tract infection.Clinical course updated.Text amended accordingly.Additional information received on 19-feb-2019 from health care professional.Additional suspect of vancomycin was added.Additional event of hearing loss worsened after antibiotics was added along with details.Clinical course updated.Text amended accordingly.Additional information received on 05-mar-2019 from health care professional.Medical history of chronic pain to neck, chronic pain to rt shoulder, chronic pain to lower back, osteoporosis, head pain, head collision, lower bilateral extremities pain, fell added.Family history of hypertension, heart disease, stroke, copd added.Surgical history of knee surgery added.Event of rt knee red and heat added.Verbatim updated from swelling in right knee to swelling in right knee/swollen to size of volleyball.Clinical course updated.Text amended accordingly.Additional information was received on 24-apr-2019 from the lawyer.Medical history was updated.Additional event of slow cadence was added.Verbatim for pain in right knee was updated to pain in right knee/tenderness anterior knee/arthritic pain right knee.Verbatim for edema right knee was updated to edema right knee/ fluctuating knee edema/ edema left knee.Outcome for pain in right knee/tenderness anterior knee/arthritic pain right knee was updated to not recovered from unknown.Onset date for the event of septic arthritis of right knee was added.Clinical course updated, and text amended accordingly.Additional information was received on 26-apr-2019 from the lawyer.Medical history updated by adding the sinusitis, drug allergy, vocal cord surgery, cataract removal, heart attack, heart condition, lung disease, sleep apnea/ snoring, depression, smoking, cancer, dizziness, vestibular neuronitis, congestion for left ear, fever, vertigo, decrease in hearing, abrasion of right ear canal, sensorineural hearing loss, hearing aid, superficial mycosis, nasal congestion, allergic rhinitis, dysphagia, throat pain, swelling, mass or lump in head and neck, acute upper respiratory infections of unspecified site, difficulty talking, fiberoptic laryngoscopy and celestone.Concomitant medications updated by adding fluticasone propionate, glycopyrronium bromide (robinul), ciprofloxacin hydrochloride, vitamin b12, escitalopram oxalate (lexapro) and nebivolol hydrochloride (bystolic).Text amended accordingly.

Event Description

Immobilized; walking difficulty [mobility decreased]; septic arthritis of right knee [arthritis septic]; adverse event nos [adverse event nos] ; moderate ecchymasis left knee [ecchymosis injection site]; total bilirubin increased [bilirubin increased]; red blood cell count decreased [red blood cell count decreased]; mean corpuscular volume increased [mean corpuscular volume increased]; mean cell hemoglobin increased [mean cell hemoglobin increased]; neutrophil percentage increased [neutrophil percentage increased]; lymphocyte percentage decreased [lymphocyte percentage decreased]; lymphocyte count decreased [lymphocyte count decreased]; platelet count decreased [platelet count decreased] ; serum potassium decreased [serum potassium decreased]; blood urea nitrogen increased [blood urea nitrogen increased]; edema right knee [edema knees]; elevated d-dimer [fibrin d dimer increased]; swelling in both legs [swelling of legs] ; stress right knee [stiff knees] ; knee effusion [effusion (r) knee]; pain in right knee [pain in knee] ; swelling in right knee [swelling of r knee]; effusion of left elbow [effusion of elbow].Case narrative: based on the information received on 11-sep-2018 the case became medically confirmed.Upon internal review on 11-sep-2018 the case upgraded from non-valid to valid as new events were added.Initial information received on 09-aug-2018 and 15-aug-2018 was processed together regarding an unsolicited serious legal case from united states received from a consumer.This case involves a 67 years old male patient who experienced septic arthritis of right knee, adverse event nos, immobilized, moderate ecchymasis left knee, pain in right knee, swelling in right knee, edema right knee, stress right knee and knee effusion(latency: unknown), total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased (latency: 3 days), swelling in both legs, effusion of left elbow and elevated d-dimer (latency: unknown) while he was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The past medical history included arthritis due to other bacteria, right knee from (b)(6) 2017, abnormal heart rhythm, hypertension, spinal stenosis, decreased hearing, feet swelling, cardiac pacemaker insertion on (b)(6) 2014, allergy with codeine, hypersensitive heart disease with heart failure on (b)(6) 2017, obstructive sleep apnea from (b)(6) 2017, gastrooesophageal reflux disease without esophagitis on (b)(6) 2017, seizure, migraine, back problems, kidney stone and arthritis joint, cardiomyopathy, pneumonia, pneumonia (trouble with short and long term memory), tremors, trouble with balance/gait, shuffling feet, intermittent headache, shortness of breath, large hematoma of left arm bicep, change in vision, thoracic spondylosis right groin pain, bilateral renal cysts (including large cyst in right kidney measuring up to 10.7 cm).The patient's concurrent conditions included at the time of the event, the patient had ongoing elbow tendonitis in 2018, chronic atrial fibrillation, varicose veins for which symptoms include mild edema and some leg pain, aggravated by prolonged standing, chest pain, chronic fatigue, daytime somnolence, hyperlipidemia, right leg with painful varicose veins, allergy to norco, allergy to pravastatin sodium and atorvastatin calcium with side effect of myalgias.The patient was a non-tobacco user and abstained from alcohol at the time of this report.Surgical history included cholecystectomy (gall bladder removed), patellectomy, appendectomy, rotator cuff repair, knee replacement, orthopedic surgeries, shoulder surgery bilaterally, eye surgery, foot surgery, cardioversion in (b)(6) 2014, heart catheterization on (b)(6) 2014, right heart catheterization with on (b)(6) 2017.The past vaccination(s) were not provided.Patient's mother had history of coronary artery disease.Concomitant medications included meloxicam; amlodipine besylate (amlodipine besylate); acetylsalicylic acid (aspirin); ondansetron, piperacillin sodium, tazobactam sodium (zosyn), cyanocobalamin (cyanocobalamin); fish oil (omega 3 fish oils); rivaroxaban (xarelto); trazodone hcl (trazodone hcl); levetiracetam (levetiracetam); calcium carbonate, colecalciferol (calcium carbonate with d3); ubidecarenone; ezetimibe (zetia); primidone; methocarbamol; spironolactone; valsartan (valsartan); omeprazole (prilosec), bisoprolol fumarate; furosemide (lasix); clonazepam; glycopyrrolate; oxycodone; betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); and hydrochlorothiazide, amlodipine besilate (norvasc), levetiracetam (keppra), trazodone hydrochloride (desryl), meloxicam (mobic), fish oil, testosterone cipionate and potassium chloride.On (b)(6) 2017, the patient received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown dose once (lot - unknown) for arthritis.On an unknown date in 2017, the patient developed septic arthritis of right knee (arthritis bacterial).On (b)(6) 2017 after a latency of 3 days total bilirubin was 1.9 mg/dl, red blood cell count was 4.49x10e6/ml, mean corpuscular volume was 101.2 fl, mean cell hemoglobin was 35.2 %, neutrophil percentage was 75.5%, lymphocyte percentage was 13%, lymphocyte count was 0.70x10e3/ul, platelet count was 118x10e3/ul, serum potassium was 3.4mmol/l and blood urea nitrogen was 22mg/dl.This event was leading to intervention.The patient was hospitalized for this event, adverse event nos, was immobilized (mobility decreased), had moderate ecchymasis left knee, pain in right knee (arthralgia), swelling in right knee (joint swelling), edema right knee (oedema peripheral), stress right knee (joint stiffness) and knee effusion (joint effusion).On (b)(6) 2017, relevant laboratory test results included blood albumin 3.4 g/dl [low], blood bilirubin 1.9 mg/dl [high], lymphocyte percentage decreased 13 % [low], blood potassium 3.2 mmol/l [low], carbon dioxide increased 32 mg/dl [high], neutrophil percentage increased 75.5 % [high], platelet count decreased 126 10*3/ml [low], mean cell volume 99.5 fl [high], red blood cell count decreased 4.45 10*6/ml [low]; on(b)(6) 2017 labs included: blood glucose 134 mg/dl [high], carbon dioxide increased 32 mg/dl [high]; mean cell haemoglobin 34.6 pg [high].On (b)(6) 2017, labs were blood urea was 23 mg/dl [high]; carbon dioxide was 33 mg/dl [high], creatinine urine was 1.24 mg/dl [high], glomerular filtration rate 58 ml/min [low]; hematocrit was 41.8 % [low]; on (b)(6) 2017, labs were blood urea 24 mg/dl, mean cell haemoglobin 34.6 pg [high], platelet count decreased was 146 10*3/ml [low]; red blood cell count decreased 4.6 10*6/ml [low], white blood cell count decreased 4.6 10*3/ml [low].The patient was put on 6-week iv antibiotic therapy.A surgery was performed to correct septic arthritis.The patient was using a rolling walker for ambulation.On (b)(6) 2017, the patient reported no falls, good appetite and normal bowel movements.The surgical wound was dressed on regular basis.The patient tolerated the whole procedure well.On (b)(6) 2018, patient reported issues with swelling of both legs and effusion of right elbow (onset and latency: unknown).On (b)(6) 2018, patient was reported to have elevated d-dimer, shortness of breath and nuclear medicine ventilation/perfusion lung scan showed low probability of acute pulmonary embolus.Final diagnosis was knee effusion, swelling in right knee, pain in right knee, adverse event nos, septic arthritis of right knee, immobilized, stress right knee, edema right knee and moderate ecchymasis left knee, swelling in both legs, effusion of left elbow and elevated d-dimer.Corrective: vancomycin (vancomycin) for arthritis bacterial and ceftriaxone (ceftriaxone) and surgical procedure for arthritis bacterial.Use of rolling walker for immobilized; walking difficulty; not reported for swelling in both legs, effusion of left elbow and elevated d-dimer outcome: not recovered for total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased; unknown for rest of the events seriousness criteria: hospitalization and intervention required for arthritis bacteria; disability for mobility decreased.A product technical complaint (ptc) was initiated on 22-aug-2018 for synvisc.Batch number unknown, global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was 22-aug-2018.No safety issues were indicated in this review.Additional information was received on 22-aug-2018 in the form of investigation summary.Ptc results and number were added.Additional information was received on 11-sep-2018 from healthcare professional.Events of total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased was added.Medical history and concomitant medication was added.Clinical course was updated and text amended accordingly.Additional information was received on 06-dec-2018 from lawyer.Medical history updated.Concomitant medications updated.Events of swelling in both legs, effusion of left elbow and elevated d-dimer were added with details.Follow up information received on 13-dec-2018.No new information.

Event Description

Immobilized; walking difficulty [mobility decreased].Septic arthritis of right knee [arthritis septic] ([staphylococcal infection]).Moderate ecchymasis left knee [ecchymosis injection site].Total bilirubin increased [bilirubin increased].Red blood cell count decreased [red blood cell count decreased].Mean corpuscular volume increased [mean corpuscular volume increased].Mean cell hemoglobin increased [mean cell hemoglobin increased].Neutrophil percentage increased [neutrophil percentage increased].Lymphocyte percentage decreased [lymphocyte percentage decreased].Lymphocyte count decreased [lymphocyte count decreased].Platelet count decreased [platelet count decreased].Serum potassium decreased [serum potassium decreased].Blood urea nitrogen increased [blood urea nitrogen increased].Elevated d-dimer [fibrin d dimer increased].Swelling in both legs [swelling of legs].Stress right knee [stiff knees].Knee effusion [effusion (r) knee].Pain in right knee [pain in knee].Swelling in right knee [swelling of r knee].Edema right knee [edema knees].Effusion of left elbow [effusion of elbow].Case narrative: based on the information received on 11-sep-2018 the case became medically confirmed.Upon internal review the case upgraded from non-valid to valid as new events were added.Initial information received on 09-aug-2018 and 15-aug-2018 was processed together regarding an unsolicited serious legal case from united states received from a consumer.This case involves a 67 years old male patient who experienced septic arthritis of right knee, immobilized, moderate ecchymasis left knee, pain in right knee, swelling in right knee, edema right knee, stress right knee and knee effusion(latency: unknown), total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased (latency: 3 days), swelling in both legs, effusion of left elbow and elevated d-dimer (latency: unknown) while he was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The past medical history included memory loss, convulsions, impairment of balance, hearing loss, sexual dysfunction, hypersomnolence, abnormal heart rhythm, hypertension, spinal stenosis, decreased hearing, feet swelling, cardiac pacemaker insertion on (b)(6) 2014, allergy with codeine, hypersensitive heart disease with heart failure on (b)(6) 2017, obstructive sleep apnea from (b)(6) 2017 (patient was wearing (positive airway pressure) pap every night), gastrooesophageal reflux disease without esophagitis on (b)(6) 2017, seizure (last episode on (b)(6) 2013), migraine, back problems, kidney stone and arthritis joint, cardiomyopathy, pneumonia, pneumonia (trouble with short and long term memory), tremors, trouble with balance/gait, shuffling feet, intermittent headache, shortness of breath, large hematoma of left arm bicep, change in vision, thoracic spondylosis right groin pain, bilateral renal cysts (including large cyst in right kidney measuring up to 10.7 cm).The patient's concurrent conditions included at the time of the event, the patient had ongoing elbow tendonitis in 2018, chronic atrial fibrillation, varicose veins for which symptoms include mild edema and some leg pain, aggravated by prolonged standing, chest pain, chronic fatigue, daytime somnolence, hyperlipidemia, right leg with painful varicose veins, allergy to norco, allergy to pravastatin sodium and atorvastatin calcium with side effect of myalgias.The patient was a non-tobacco user and abstained from alcohol at the time of this report.Surgical history included cholecystectomy (gall bladder removed), patellectomy, appendectomy, rotator cuff repair, knee replacement, orthopedic surgeries, shoulder surgery bilaterally, eye surgery, foot surgery, cardioversion in jun-2014, heart catheterization on (b)(6) 2014, right heart catheterization with on (b)(6) 2017.Patient's mother had history of coronary artery disease.Patient got the flu shot in oct-2017.Patient's temperature that night it was 100.Patient got a shot of rocephin and levaquin.Patient also had fevers to 101 and continued to get worse.Concomitant medications included meloxicam; amlodipine besylate (amlodipine besylate); aacetylsalicylic acid (aspirin); ondansetron, piperacillin sodium, tazobactam sodium (zosyn), cyanocobalamin (cyanocobalamin); fish oil (omega 3 fish oils); rivaroxaban (xarelto); trazodone hcl (trazodone hcl); levetiracetam (levetiracetam); calcium carbonate, colecalciferol (calcium carbonate with d3); ubidecarenone; ezetimibe (zetia); primidone; methocarbamol; spironolactone; valsartan (valsartan); omeprazole (prilosec), bisoprolol fumarate; furosemide (lasix); clonazepam; glycopyrrolate; oxycodone; betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); and hydrochlorothiazide, amlodipine besilate (norvasc), levetiracetam (keppra), trazodone hydrochloride (desryl), meloxicam (mobic), fish oil, testosterone cipionate ,potassium chloride and nystatin.On (b)(6) 2017, the patient received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown dose once (lot: unknown) for arthritis.On an unknown date in 2017, the patient developed septic arthritis of right knee (arthritis bacterial).It was reported that the patient had a staph infection of right knee and had to have major surgery.On (b)(6) 2017 after a latency of 3 days total bilirubin was 1.9 mg/dl, red blood cell count was 4.49x10e6/ml, mean corpuscular volume was 101.2 fl, mean cell hemoglobin was 35.2 %, neutrophil percentage was 75.5%, lymphocyte percentage was 13%, lymphocyte count was 0.70x10e3/ul, platelet count was 118x10e3/ul, serum potassium was 3.4mmol/l and blood urea nitrogen was 22mg/dl.This event was leading to intervention.The patient was hospitalized for this event, adverse event nos, was immobilized (mobility decreased), had moderate ecchymasis left knee, pain in right knee (arthralgia), swelling in right knee (joint swelling), edema right knee (oedema peripheral), stress right knee (joint stiffness) and knee effusion (joint effusion).On (b)(6) 2017, relevant laboratory test results included blood albumin 3.4 g/dl [low], blood bilirubin 1.9 mg/dl [high], lymphocyte percentage decreased 13 % [low], blood potassium 3.2 mmol/l [low], carbon dioxide increased 32 mg/dl [high], neutrophil percentage increased 75.5 % [high], platelet count decreased 126 10*3/ml [low], mean cell volume 99.5 fl [high], red blood cell count decreased 4.45 10*6/ml [low]; on (b)(6) 2017 labs included: blood glucose 134 mg/dl [high], carbon dioxide increased 32 mg/dl [high]; mean cell haemoglobin 34.6 pg [high].On (b)(6) 2017, the patient reported no falls, good appetite and normal bowel movements.On (b)(6) 2017, labs were blood urea 24 mg/dl, mean cell haemoglobin 34.6 pg [high], platelet count decreased was 146 10*3/ml [low]; red blood cell count decreased 4.6 10*6/ml [low], white blood cell count decreased 4.6 10*3/ml [low].The patient was put on 6-week iv antibiotic therapy.On (b)(6) 2017, labs were blood urea was 23 mg/dl [high]; carbon dioxide was 33 mg/dl [high], creatinine urine was 1.24 mg/dl [high], glomerular filtration rate 58 ml/min [low]; hematocrit was 41.8 % [low].A surgery was performed to correct septic arthritis.The patient was using a rolling walker for ambulation.The surgical wound was dressed on regular basis.The patient tolerated the whole procedure well.Patient had to use brace.On (b)(6) 2018, patient reported issues with swelling of both legs and effusion of right elbow (onset and latency: unknown).On (b)(6) 2018, patient was reported to have elevated d-dimer, shortness of breath and nuclear medicine ventilation/perfusion lung scan showed low probability of acute pulmonary embolus.Corrective: vancomycin (vancomycin) for arthritis bacterial and ceftriaxone (ceftriaxone) and surgical procedure for arthritis bacterial and staph infection of right knee.Use of rolling walker for immobilized; walking difficulty; not reported for swelling in both legs, effusion of left elbow and elevated d-dimer.Outcome: not recovered for total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased; unknown for rest of the events.Seriousness criteria: hospitalization and intervention required for arthritis bacteria; hospitalization, medically significant and intervention required for disability for mobility decreased.A product technical complaint (ptc) was initiated on 22-aug- 2018 for synvisc.Batch number unknown, global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was 22-aug-2018.No safety issues were indicated in this review.Additional information was received on 22-aug-2018 in the form of investigation summary.Ptc results and number were added.Additional information was received on 11-sep-2018 from healthcare professional.Events of total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased was added.Medical history and concomitant medication was added.Clinical course was updated and text amended accordingly.Additional information was received on 06-dec-2018 from lawyer.Medical history updated.Concomitant medications updated.Events of swelling in both legs, effusion of left elbow and elevated d-dimer were added with details.Follow up information received on 13-dec-2018.No new information.Additional information received on 11-jan-2019 from the lawyer.Therapy onset dates for concomitant medications updated.Concomitant medication nystatin was added.Clinical course updated and text amended accordingly additional information received on 14-jan-2019 and 16-jan-2019 (both the information was processed together with clock start date 14-jan-2019) from lawyer.Medical history was updated.Additional symptom of staph infection of right knee was added along with details.The event of adverse event nos was deleted from the case.Clinical course updated and text amended accordingly.

Event Description

Immobilized; walking difficulty [mobility decreased] septic arthritis of right knee [arthritis septic] ([staphylococcal infection]) total bilirubin increased [bilirubin increased] red blood cell count decreased [red blood cell count decreased] mean corpuscular volume increased [mean corpuscular volume increased] mean cell hemoglobin increased [mean cell hemoglobin increased] neutrophil percentage increased [neutrophil percentage increased] lymphocyte percentage decreased [lymphocyte percentage decreased] lymphocyte count decreased [lymphocyte count decreased] platelet count decreased [platelet count decreased] serum potassium decreased [serum potassium decreased] blood urea nitrogen increased [blood urea nitrogen increased] elevated d-dimer [fibrin d dimer increased] swelling in both legs [swelling of legs] urinary tract infection [urinary tract infection] edema right knee [edema knees] unable to control bladder [loss of bladder sensation] fever [fever] chills [chills] dark urine [urine discoloration] moderate ecchymasis left knee [ecchymosis injection site] effusion of left elbow [effusion of elbow] pain in right knee [pain in knee] swelling in right knee [swelling of r knee] knee effusion [effusion (r) knee] stress right knee [stiff knees] case narrative: based on the information received on 11-sep-2018 the case became medically confirmed.Upon internal review the case upgraded from non-valid to valid as new events were added.Initial information received on 09-aug-2018 and 15-aug-2018 was processed together regarding an unsolicited serious legal case from united states received from a consumer.This case involves a 67 years old male patient who experienced septic arthritis of right knee, immobilized, moderate ecchymasis left knee, pain in right knee, swelling in right knee, edema right knee, stress right knee and knee effusion(latency: unknown), total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased (latency: 3 days), swelling in both legs, effusion of left elbow and elevated d-dimer (latency: unknown), fever, chills, dark urine, unable to control bladder, urinary tract infection while he was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The past medical history included right eye red, increased cholesterol, depression, stress fractures (possible at third metatarsal), wheelchair user, left foot problem/pain, diffuse edema in foot, gout in his heels, peroneus longus tendon repair due to rupture (sesamoid fracture adjacent to the cuboid), walking aid user (crutches), foot inversion injury on (b)(6) 2003, stroke, bladder problems, popping sensation in elbow (once a day when he reaches full extension), memory loss, convulsions, impairment of balance, hearing loss, sexual dysfunction, hypersomnolence, abnormal heart rhythm, spinal stenosis, decreased hearing, feet swelling, on (b)(6) 2003 dexa scan which revealed no significant evidence of osteopenia or osteoporosis, cardiac pacemaker insertion on (b)(6) 2014, seizure (last episode on (b)(6) 2013), hypersensitive heart disease with heart failure on(b)(6) 2017, obstructive sleep apnea from (b)(6) 2017 (patient was wearing (positive airway pressure) pap every night), gastrooesophageal reflux disease without esophagitis on (b)(6) 2017migraine, back problems, kidney stone and arthritis joint, cardiomyopathy, pneumonia, pneumonia (trouble with short and long term memory), tremors, trouble with balance/gait, shuffling feet, intermittent headache, shortness of breath, large hematoma of left arm bicep, change in vision, thoracic spondylosis right groin pain, bilateral renal cysts (including large cyst in right kidney measuring up to 10.7 cm), flu shot in (b)(6) 2017, patient's temperature that night it was 100.Patient got a shot of rocephin and levaquin.Patient also had fevers to 101 and continued to get worse.The patient's concurrent conditions included at the time of the event, the patient had ongoing elbow tendonitis in 2018, chronic atrial fibrillation, hypertension, fentanyl allergy, chronic peroneal tendon synovitis, varicose veins for which symptoms include mild edema and some leg pain, aggravated by prolonged standing, chest pain, chronic fatigue, daytime somnolence, hyperlipidemia, right leg with painful varicose veins, allergy with codeine, allergy to norco, allergy to pravastatin sodium and atorvastatin calcium with side effect of myalgias.The patient was a non-tobacco user and abstained from alcohol at the time of this report.Surgical history included left ankle surgery (b)(6) 2003), cholecystectomy (gall bladder removed), total knee arthroplasty on 24-may-2005, patellectomy, appendectomy, rotator cuff repair, knee replacement, orthopedic surgeries, shoulder surgery bilaterally, eye surgery, bil rotator cuff, left foot surgery, cardioversion in (b)(6) 2014, heart catheterization on (b)(6) 2014, right heart catheterization with on (b)(6) 2017.Patient's mother, two sisters and brother had history of coronary artery disease, father had history of kidney failure, two sisters and brother also had history of osteopenia.Concomitant medications included meloxicam; amlodipine besylate (amlodipine besylate); aacetylsalicylic acid (aspirin); ondansetron, oseltamivir, piperacillin sodium, tazobactam sodium (zosyn), cyanocobalamin (cyanocobalamin); fish oil (omega 3 fish oils); rivaroxaban (xarelto); trazodone hcl (trazodone hcl); levetiracetam (levetiracetam); calcium carbonate, colecalciferol (calcium carbonate with d3); ubidecarenone; ezetimibe (zetia); primidone; methocarbamol; spironolactone; valsartan (valsartan); omeprazole (prilosec), bisoprolol fumarate; furosemide (lasix); clonazepam; glycopyrrolate; oxycodone; betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); and hydrochlorothiazide, amlodipine besilate (norvasc), levetiracetam (keppra), trazodone hydrochloride (desryl), meloxicam (mobic), fish oil, testosterone cipionate ,potassium chloride and nystatin.On (b)(6) 2017, the patient received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown dose once (lot - unknown) for arthritis.On an unknown date in 2017, the patient developed septic arthritis of right knee (arthritis bacterial).It was reported that the patient had a staph infection of right knee and had to have major surgery.On (b)(6) 2017 after a latency of 3 days total bilirubin was 1.9 mg/dl, red blood cell count was 4.49x10e6/ml, mean corpuscular volume was 101.2 fl, mean cell hemoglobin was 35.2 %, neutrophil percentage was 75.5%, lymphocyte percentage was 13%, lymphocyte count was 0.70x10e3/ul, platelet count was 118x10e3/ul, serum potassium was 3.4mmol/l and blood urea nitrogen was 22mg/dl.This event was leading to intervention.The patient was hospitalized for this event, adverse event nos, was immobilized (mobility decreased), had moderate ecchymasis left knee, pain in right knee (arthralgia), swelling in right knee (joint swelling), edema right knee (oedema peripheral), stress right knee (joint stiffness) and knee effusion (joint effusion).On (b)(6) 2017, relevant laboratory test results included blood albumin 3.4 g/dl [low], blood bilirubin 1.9 mg/dl [high], lymphocyte percentage decreased 13 % [low], blood potassium 3.2 mmol/l [low], carbon dioxide increased 32 mg/dl [high], neutrophil percentage increased 75.5 % [high], platelet count decreased 126 10*3/ml [low], mean cell volume 99.5 fl [high], red blood cell count decreased 4.45 10*6/ml [low]; on (b)(6) 2017 labs included: blood glucose 134 mg/dl [high], carbon dioxide increased 32 mg/dl [high]; mean cell haemoglobin 34.6 pg [high].On (b)(6) 2017, the patient reported no falls, good appetite and normal bowel movements.On (b)(6) 2017, labs were blood urea 24 mg/dl, mean cell haemoglobin 34.6 pg [high], platelet count decreased was 146 10*3/ml [low]; red blood cell count decreased 4.6 10*6/ml [low], white blood cell count decreased 4.6 10*3/ml [low].The patient was put on 6-week iv antibiotic therapy.On (b)(6) 2017, labs were blood urea was 23 mg/dl [high]; carbon dioxide was 33 mg/dl [high], creatinine urine was 1.24 mg/dl [high], glomerular filtration rate 58 ml/min [low]; hematocrit was 41.8 % [low].A surgery was performed to correct septic arthritis.The patient was using a rolling walker for ambulation.The surgical wound was dressed on regular basis.The patient tolerated the whole procedure well.Patient had to use brace.On (b)(6) 2018, patient was unable to control bladder (latency: 3 months 27 days).On (b)(6) 2018, patient developed a fever (latency: 4 months) of 102 at night.On (b)(6) 2018, patient reported to the clinic with complaints of chills (latency: 4 months 1 day) and dark urine (latency: 4 months 1 day).Further, urine analysis of the patient was performed which confirmed urinary tract infection (latency: 4 months 1 day) and patient was prescribed rocephin, cipro and pyridium as a corrective for it.Further, the patient was advised to increase intake of oral fluids and to follow up if his condition worsened.On (b)(6) 2018, patient reported issues with swelling of both legs and effusion of right elbow (onset and latency: unknown).On(b)(6) 2018, patient was reported to have elevated d-dimer, shortness of breath and nuclear medicine ventilation/perfusion lung scan showed low probability of acute pulmonary embolus.Corrective: vancomycin (vancomycin) for arthritis bacterial and ceftriaxone (ceftriaxone) and surgical procedure for arthritis bacterial and staph infection of right knee.Use of rolling walker for immobilized; walking difficulty; not reported for swelling in both legs, effusion of left elbow and elevated d-dimer; rocephin, cipro and pyridium for urinary tract infection; not reported for rest.Outcome: not recovered for total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased; unknown for rest of the events.Seriousness criteria: hospitalization and intervention required for septic arthritis of right knee; disability for immobilized; walking difficulty.A product technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc.Batch number unknown, global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was 22-aug-2018.No safety issues were indicated in this review.Additional information was received on 22-aug-2018 in the form of investigation summary.Ptc results and number were added.Additional information was received on 11-sep-2018 from healthcare professional.Events of total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased was added.Medical history and concomitant medication was added.Clinical course was updated and text amended accordingly.Additional information was received on 06-dec-2018 from lawyer.Medical history updated.Concomitant medications updated.Events of swelling in both legs, effusion of left elbow and elevated d-dimer were added with details.Follow up information received on 13-dec-2018.No new information.Additional information received on 11-jan-2019 from the lawyer.Therapy onset dates for concomitant medications updated.Concomitant medication nystatin was added.Clinical course updated and text amended accordingly additional information received on 14-jan-2019 and 16-jan-2019 (both the information was processed together with clock start date 14-jan-2019) from lawyer.Medical history was updated.Additional symptom of staph infection of right knee was added along with details.The event of adverse event nos was deleted from the case.Clinical course updated and text amended accordingly.Follow up information received on 24-jan-2019 and 25-jan-2019 from lawyer.No new information.Additional information was received on 30-jan-2019 from lawyer.Medical history was updated.Clinical course updated.Text amended accordingly.Additional information received on 11-feb-2019 from lawyer.Medical history of wheelchair user, right eye red, increased cholesterol, depression added.Surgical history of bil rotator cuff added.Concomitant medication of oseltamivir added.Events of fever, chills, dark urine, unable to control bladder, urinary tract infection.Clinical course updated.Text amended accordingly.

Event Description

Immobilized; walking difficulty [mobility decreased] septic arthritis of right knee [arthritis septic] ([staphylococcal infection]) hearing loss was worse after the antibiotic treatment [hearing loss bilateral] ([condition aggravated]) total bilirubin increased [bilirubifn increased] red blood cell count decreased [red blood cell count decreased] mean corpuscular volume increased [mean corpuscular volume increased] mean cell hemoglobin increased [mean cell hemoglobin increased] neutrophil percentage increased [neutrophil percentage increased] lymphocyte percentage decreased [lymphocyte percentage decreased] lymphocyte count decreased [lymphocyte count decreased] platelet count decreased [platelet count decreased] serum potassium decreased [serum potassium decreased] blood urea nitrogen increased [blood urea nitrogen increased] elevated d-dimer [fibrin d dimer increased] swelling in both legs [swelling of legs] urinary tract infection [urinary tract infection] edema right knee [edema knees] unable to control bladder [loss of bladder sensation] fever [fever] chills [chills] dark urine [urine discoloration] moderate ecchymasis left knee [ecchymosis injection site] effusion of left elbow [effusion of elbow] pain in right knee [pain in knee] swelling in right knee [swelling of r knee] knee effusion [effusion (r) knee] stress right knee [stiff knees] case narrative: based on the information received on 11-sep-2018 the case became medically confirmed.Upon internal review the case upgraded from non-valid to valid as new events were added.Initial information received on 09-aug-2018 and 15-aug-2018 was processed together regarding an unsolicited serious legal case from united states received from a consumer.This case involves a 67 years old male patient who experienced septic arthritis of right knee, immobilized, moderate ecchymasis left knee, pain in right knee, swelling in right knee, edema right knee, stress right knee and knee effusion(latency: unknown), total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased (latency: 3 days), swelling in both legs, effusion of left elbow and elevated d-dimer (latency: unknown), fever, chills, dark urine, unable to control bladder, urinary tract infection, hearing loss was worse after the antibiotic treatment while he was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc) and vancomycin.The past medical history included right eye red, increased cholesterol, depression, stress fractures (possible at third metatarsal), wheelchair user, left foot problem/pain, diffuse edema in foot, gout in his heels, peroneus longus tendon repair due to rupture (sesamoid fracture adjacent to the cuboid), walking aid user (crutches), foot inversion injury on (b)(6) 2003, stroke, bladder problems, popping sensation in elbow (once a day when he reaches full extension), memory loss, convulsions, impairment of balance, hearing loss, sexual dysfunction, hypersomnolence, abnormal heart rhythm, spinal stenosis, decreased hearing, feet swelling, on (b)(6) 2003 dexa scan which revealed no significant evidence of osteopenia or osteoporosis, cardiac pacemaker insertion on(b)(6) 2014, seizure (last episode on (b)(6) 2013), hypersensitive heart disease with heart failure on (b)(6) 2017, obstructive sleep apnea from (b)(6) 2017 (patient was wearing (positive airway pressure) pap every night), gastrooesophageal reflux disease without esophagitis on (b)(6) 2017migraine, back problems, kidney stone and arthritis joint, cardiomyopathy, pneumonia, pneumonia (trouble with short and long term memory), tremors, trouble with balance/gait, shuffling feet, intermittent headache, shortness of breath, large hematoma of left arm bicep, change in vision, thoracic spondylosis right groin pain, bilateral renal cysts (including large cyst in right kidney measuring up to 10.7 cm), flu shot in (b)(6) 2017, patient's temperature that night it was 100.Patient got a shot of rocephin and levaquin.Patient also had fevers to 101 and continued to get worse.The patient's concurrent conditions included at the time of the event, the patient had ongoing elbow tendonitis in 2018, chronic atrial fibrillation, hypertension, fentanyl allergy, chronic peroneal tendon synovitis, varicose veins for which symptoms include mild edema and some leg pain, aggravated by prolonged standing, chest pain, chronic fatigue, daytime somnolence, hyperlipidemia, right leg with painful varicose veins, allergy with codeine, allergy to norco, allergy to pravastatin sodium and atorvastatin calcium with side effect of myalgias.The patient was a non-tobacco user and abstained from alcohol at the time of this report.Surgical history included left ankle surgery (b)(6) 2003), cholecystectomy (gall bladder removed), total knee arthroplasty on (b)(6) 2005, patellectomy, appendectomy, rotator cuff repair, knee replacement, orthopedic surgeries, shoulder surgery bilaterally, eye surgery, bil rotator cuff, left foot surgery, cardioversion in (b)(6) 2014, heart catheterization on (b)(6) 2014, right heart catheterization with on (b)(6) 2017.Patient's mother, two sisters and brother had history of coronary artery disease, father had history of kidney failure, two sisters and brother also had history of osteopenia.Concomitant medications included meloxicam; amlodipine besylate (amlodipine besylate); aacetylsalicylic acid (aspirin); ondansetron, oseltamivir, piperacillin sodium, tazobactam sodium (zosyn), cyanocobalamin (cyanocobalamin); fish oil (omega 3 fish oils); rivaroxaban (xarelto); trazodone hcl (trazodone hcl); levetiracetam (levetiracetam); calcium carbonate, colecalciferol (calcium carbonate with d3); ubidecarenone; ezetimibe (zetia); primidone; methocarbamol; spironolactone; valsartan (valsartan); omeprazole (prilosec), bisoprolol fumarate; furosemide (lasix); clonazepam; glycopyrrolate; oxycodone; betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); and hydrochlorothiazide, amlodipine besilate (norvasc), levetiracetam (keppra), trazodone hydrochloride (desryl), meloxicam (mobic), fish oil, testosterone cipionate ,potassium chloride and nystatin.On (b)(6) 2017, the patient received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown dose once (lot - unknown) for arthritis.On an unknown date in 2017, the patient developed septic arthritis of right knee (arthritis bacterial) and was treated with 6 weeks of vancomycin (dose, form, route, frequency: not provided).It was reported that the patient had a staph infection of right knee and had knee replacement surgery.On (b)(6) 2017 after a latency of 3 days total bilirubin was 1.9 mg/dl, red blood cell count was 4.49x10e6/ml, mean corpuscular volume was 101.2 fl, mean cell hemoglobin was 35.2 %, neutrophil percentage was 75.5%, lymphocyte percentage was 13%, lymphocyte count was 0.70x10e3/ul, platelet count was 118x10e3/ul, serum potassium was 3.4mmol/l and blood urea nitrogen was 22mg/dl.This event was leading to intervention.The patient was hospitalized for this event, adverse event nos, was immobilized (mobility decreased), had moderate ecchymasis left knee, pain in right knee (arthralgia), swelling in right knee (joint swelling), edema right knee (oedema peripheral), stress right knee (joint stiffness) and knee effusion (joint effusion).On(b)(6) 2017, relevant laboratory test results included blood albumin 3.4 g/dl [low], blood bilirubin 1.9 mg/dl [high], lymphocyte percentage decreased 13 % [low], blood potassium 3.2 mmol/l [low], carbon dioxide increased 32 mg/dl [high], neutrophil percentage increased 75.5 % [high], platelet count decreased 126 10*3/ml [low], mean cell volume 99.5 fl [high], red blood cell count decreased 4.45 10*6/ml [low]; on (b)(6) 2017 labs included: blood glucose 134 mg/dl [high], carbon dioxide increased 32 mg/dl [high]; mean cell haemoglobin 34.6 pg [high].On (b)(6) 2017, the patient reported no falls, good appetite and normal bowel movements.On (b)(6) -2017, labs were blood urea 24 mg/dl, mean cell haemoglobin 34.6 pg [high], platelet count decreased was 146 10*3/ml [low]; red blood cell count decreased 4.6 10*6/ml [low], white blood cell count decreased 4.6 10*3/ml [low].The patient was put on 6-week iv antibiotic therapy.On (b)(6) 2017, labs were blood urea was 23 mg/dl [high]; carbon dioxide was 33 mg/dl [high], creatinine urine was 1.24 mg/dl [high], glomerular filtration rate 58 ml/min [low]; hematocrit was 41.8 % [low].A surgery was performed to correct septic arthritis.The patient was using a rolling walker for ambulation.The surgical wound was dressed on regular basis.The patient tolerated the whole procedure well.Patient had to use brace.On (b)(6) 2018, patient was unable to control bladder (latency: 3 months 27 days).On (b)(6) 2018, patient developed a fever (latency: 4 months) of 102 at night.On (b)(6) 2018, patient reported to the clinic with complaints of chills (latency: 4 months 1 day) and dark urine (latency: 4 months 1 day).Further, urine analysis of the patient was performed which confirmed urinary tract infection (latency: 4 months 1 day) and patient was prescribed rocephin, cipro and pyridium as a corrective for it.Further, the patient was advised to increase intake of oral fluids and to follow up if his condition worsened.On (b)(6) 2018, patient reported issues with swelling of both legs and effusion of right elbow (onset and latency: unknown).On (b)(6) 2018, patient was reported to have elevated d-dimer, shortness of breath and nuclear medicine ventilation/perfusion lung scan showed low probability of acute pulmonary embolus.On (b)(6) 2019, patient went for evaluation of hearing loss.It was reported that the hearing loss was worse after the antibiotic treatment (onset date: unknown).Also reported that patient's post vancomycin audiogram had worsened as compared to the pre-vancomycin audiogram.Patient was also wearing bilateral hearing aids.On the same day, patient's speech audiometry results were right (ad): 55 dbhl and left ad: 50 dbhl compared to the audiogram of (b)(6) 2016 (right ear: 68% and left ear at 76% at 80 db).Patient was also offered to visit cochlear transplant surgeon.Action taken for vancomycin was unknown.Corrective: vancomycin (vancomycin) for arthritis bacterial and ceftriaxone (ceftriaxone) and total knee replacement for arthritis bacterial and staph infection of right knee.Use of rolling walker for immobilized; walking difficulty; not reported for swelling in both legs, effusion of left elbow and elevated d-dimer; rocephin, cipro and pyridium for urinary tract infection; not reported for rest outcome: not recovered for hearing loss was worse after the antibiotic treatment, total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased; unknown for rest of the events seriousness criteria: hospitalization and intervention required for septic arthritis of right knee; disability for immobilized; walking difficulty; disability and medically significant for hearing loss was worse after the antibiotic treatment a product technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc.Batch number unknown, global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was(b)(6) 2018.No safety issues were indicated in this review.Additional information was received on 22-aug-2018 in the form of investigation summary.Ptc results and number were added.Additional information was received on 11-sep-2018 from healthcare professional.Events of total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased was added.Medical history and concomitant medication was added.Clinical course was updated and text amended accordingly.Additional information was received on 06-dec-2018 from lawyer.Medical history updated.Concomitant medications updated.Events of swelling in both legs, effusion of left elbow and elevated d-dimer were added with details.Follow up information received on 13-dec-2018.No new information.Additional information received on 11-jan-2019 from the lawyer.Therapy onset dates for concomitant medications updated.Concomitant medication nystatin was added.Clinical course updated and text amended accordingly additional information received on 14-jan-2019 and 16-jan-2019 (both the information was processed together with clock start date 14-jan-2019) from lawyer.Medical history was updated.Additional symptom of staph infection of right knee was added along with details.The event of adverse event nos was deleted from the case.Clinical course updated and text amended accordingly.Follow up information received on 24-jan-2019 and 25-jan-2019 from lawyer.No new information.Additional information was received on 30-jan-2019 from lawyer.Medical history was updated.Clinical course updated.Text amended accordingly.Additional information received on 11-feb-2019 from lawyer.Medical history of wheelchair user, right eye red, increased cholesterol, depression added.Surgical history of bil rotator cuff added.Concomitant medication of oseltamivir added.Events of fever, chills, dark urine, unable to control bladder, urinary tract infection.Clinical course updated.Text amended accordingly.Additional information received on 19-feb-2019 from health care professional.Additional suspect of vancomycin was added.Additional event of hearing loss worsened after antibiotics was added along with details.Clinical course updated.Text amended accordingly.

Event Description

Immobilized; walking difficulty [mobility decreased].Septic arthritis of right knee [arthritis septic] ([staphylococcal infection]).Total bilirubin increased [bilirubin increased].Effusion of left elbow [effusion of elbow].Red blood cell count decreased [red blood cell count decreased.] mean corpuscular volume increased [mean corpuscular volume increased].Mean cell hemoglobin increased [mean cell hemoglobin increased].Neutrophil percentage increased [neutrophil percentage increased].Lymphocyte percentage decreased [lymphocyte percentage decreased].Lymphocyte count decreased [lymphocyte count decreased].Platelet count decreased [platelet count decreased].Serum potassium decreased [serum potassium decreased].Blood urea nitrogen increased [blood urea nitrogen increased].Elevated d-dimer [fibrin d dimer increased].Swelling in both legs [swelling of legs].Stress right knee [stiff knees].Knee effusion [effusion (r) knee].Pain in right knee [pain in knee].Swelling in right knee [swelling of r knee].Edema right knee [edema knees].Moderate ecchymasis left knee [ecchymosis injection site].Case narrative: based on the information received on (b)(6) 2018 the case became medically confirmed.Upon internal review the case upgraded from non-valid to valid as new events were added.Initial information received on 09-aug-2018 and 15-aug-2018 was processed together regarding an unsolicited serious legal case from united states received from a consumer.This case involves a 67 years old male patient who experienced septic arthritis of right knee, immobilized, moderate ecchymasis left knee, pain in right knee, swelling in right knee, edema right knee, stress right knee and knee effusion(latency: unknown), total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased (latency: 3 days), swelling in both legs, effusion of left elbow and elevated d-dimer (latency: unknown) while he was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).On (b)(6) 2003, patient had dexa scan which revealed no significant evidence of osteopenia or osteoporosis.The past medical history included stress fractures (possible at third metatarsal), left foot problem/pain, diffuse edema in foot, gout in his heels, peroneus longus tendon repair due to rupture (sesamoid fracture adjacent to the cuboid), walking aid user (crutches), foot inversion injury on (b)(6) 2003, fentanyl allergy, bladder problems, left ankle surgery (on (b)(6) 2003), popping sensation in elbow (once a day when he reaches full extension), chronic peroneal tendon synovitis, memory loss, convulsions, impairment of balance, hearing loss, sexual dysfunction, hypersomnolence, abnormal heart rhythm, hypertension, spinal stenosis, decreased hearing, feet swelling, cardiac pacemaker insertion on (b)(6) 2014, allergy with codeine, hypersensitive heart disease with heart failure on (b)(6) 2017, obstructive sleep apnea from on (b)(6) 2017 (patient was wearing (positive airway pressure) pap every night), gastrooesophageal reflux disease without esophagitis on (b)(6) 2017, seizure (last episode on (b)(6) 2013), migraine, back problems, kidney stone and arthritis joint, cardiomyopathy, pneumonia, pneumonia (trouble with short and long term memory), tremors, trouble with balance/gait, shuffling feet, intermittent headache, shortness of breath, large hematoma of left arm bicep, change in vision, thoracic spondylosis right groin pain, bilateral renal cysts (including large cyst in right kidney measuring up to 10.7 cm).The patient's concurrent conditions included at the time of the event, the patient had ongoing elbow tendonitis in 2018, chronic atrial fibrillation, varicose veins for which symptoms include mild edema and some leg pain, aggravated by prolonged standing, chest pain, chronic fatigue, daytime somnolence, hyperlipidemia, right leg with painful varicose veins, allergy to norco, allergy to pravastatin sodium and atorvastatin calcium with side effect of myalgias.The patient was a non-tobacco user and abstained from alcohol at the time of this report.Surgical history included cholecystectomy (gall bladder removed), patellectomy, appendectomy, rotator cuff repair, knee replacement, orthopedic surgeries, shoulder surgery bilaterally, eye surgery, foot surgery, cardioversion on (b)(6) 2014, heart catheterization on (b)(6) 2014, right heart catheterization with on (b)(6) 2017.Patient's mother, two sisters and brother had history of coronary artery disease, father had history of kidney failure, two sisters and brother also had history of osteopenia.Patient got the flu shot on (b)(6) 2017.Patient's temperature that night it was 100.Patient got a shot of rocephin and levaquin.Patient also had fevers to 101 and continued to get worse.Concomitant medications included meloxicam; amlodipine besylate (amlodipine besylate); "acetylsalicylic" acid (aspirin); ondansetron, piperacillin sodium, tazobactam sodium (zosyn), cyanocobalamin (cyanocobalamin); fish oil (omega 3 fish oils); rivaroxaban (xarelto); trazodone hcl (trazodone hcl); levetiracetam (levetiracetam); calcium carbonate, "cholecalciferol" (calcium carbonate with d3); ubidecarenone; ezetimibe (zetia); primidone; methocarbamol; spironolactone; valsartan (valsartan); omeprazole (prilosec), bisoprolol fumarate; furosemide (lasix); clonazepam; glycopyrrolate; oxycodone; betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, "cholecalciferol", copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); and hydrochlorothiazide, amlodipine besilate (norvasc), levetiracetam (keppra), trazodone hydrochloride (desryl), meloxicam (mobic), fish oil, testosterone cipionate ,potassium chloride and nystatin.On (b)(6) 2017, the patient received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown dose once (lot - unknown) for arthritis.On an unknown date in 2017, the patient developed septic arthritis of right knee (arthritis bacterial).It was reported that the patient had a staph infection of right knee and had to have major surgery.On (b)(6) 2017 after a latency of 3 days total bilirubin was 1.9 mg/dl, red blood cell count was 4.49x10e6/ml, mean corpuscular volume was 101.2 fl, mean cell hemoglobin was 35.2 %, neutrophil percentage was 75.5%, lymphocyte percentage was 13%, lymphocyte count was 0.70x10e3/ul, platelet count was 118x10e3/ul, serum potassium was 3.4mmol/l and blood urea nitrogen was 22mg/dl.This event was leading to intervention.The patient was hospitalized for this event, adverse event nos, was immobilized (mobility decreased), had moderate ecchymasis left knee, pain in right knee (arthralgia), swelling in right knee (joint swelling), edema right knee (oedema peripheral), stress right knee (joint stiffness) and knee effusion (joint effusion).On (b)(6) 2017, relevant laboratory test results included blood albumin 3.4 g/dl [low], blood bilirubin 1.9 mg/dl [high], lymphocyte percentage decreased 13 % [low], blood potassium 3.2 mmol/l [low], carbon dioxide increased 32 mg/dl [high], neutrophil percentage increased 75.5 % [high], platelet count decreased 126 10 3/ml [low], mean cell volume 99.5 fl [high], red blood cell count decreased 4.45 10 6/ml [low]; on (b)(6) 2017 labs included: blood glucose 134 mg/dl [high], carbon dioxide increased 32 mg/dl [high]; mean cell haemoglobin 34.6 pg [high].On (b)(6) 2017, the patient reported no falls, good appetite and normal bowel movements.On (b)(6) 2017, labs were blood urea 24 mg/dl, mean cell haemoglobin 34.6 pg [high], platelet count decreased was 146 10*3/ml [low]; red blood cell count decreased 4.6 10 6/ml [low], white blood cell count decreased 4.6 10 3/ml [low].The patient was put on 6-week iv antibiotic therapy.On (b)(6) 2017, labs were blood urea was 23 mg/dl [high]; carbon dioxide was 33 mg/dl [high], creatinine urine was 1.24 mg/dl [high], glomerular filtration rate 58 ml/min [low]; hematocrit was 41.8 % [low].A surgery was performed to correct septic arthritis.The patient was using a rolling walker for ambulation.The surgical wound was dressed on regular basis.The patient tolerated the whole procedure well.Patient had to use brace.On (b)(6) 2018, patient reported issues with swelling of both legs and effusion of right elbow (onset and latency: unknown).On (b)(6) 2018, patient was reported to have elevated d-dimer, shortness of breath and nuclear medicine ventilation/perfusion lung scan showed low probability of acute pulmonary embolus.Corrective: vancomycin (vancomycin) for arthritis bacterial and ceftriaxone (ceftriaxone) and surgical procedure for arthritis bacterial and staph infection of right knee.Use of rolling walker for immobilized; walking difficulty; not reported for swelling in both legs, effusion of left elbow and elevated d-dimer.Outcome: not recovered for total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased; unknown for rest of the events.Seriousness criteria: hospitalization and intervention required for arthritis bacteria; hospitalization, medically significant and intervention required for disability for mobility decreased.A product technical complaint (ptc) was initiated on 22-aug-2018 for synvisc.Batch number unknown, global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was 22-aug-2018.No safety issues were indicated in this review.Additional information was received on 22-aug-2018 in the form of investigation summary.Ptc results and number were added.Additional information was received on 11-sep-2018 from healthcare professional.Events of total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased was added.Medical history and concomitant medication was added.Clinical course was updated and text amended accordingly.Additional information was received on 06-dec-2018 from lawyer.Medical history updated.Concomitant medications updated.Events of swelling in both legs, effusion of left elbow and elevated d-dimer were added with details.Follow up information received on 13-dec-2018.No new information.Additional information received on 11-jan-2019 from the lawyer.Therapy onset dates for concomitant medications updated.Concomitant medication nystatin was added.Clinical course updated and text amended accordingly.Additional information received on 14-jan-2019 and 16-jan-2019 (both the information was processed together with clock start date 14-jan-2019) from lawyer.Medical history was updated.Additional symptom of staph infection of right knee was added along with details.The event of adverse event nos was deleted from the case.Clinical course updated and text amended accordingly.Follow up information received on 24-jan-2019 and 25-jan-2019 from lawyer.No new information.Additional information was received on 30-jan-2019 from lawyer.Medical history was updated.Clinical course updated.Text amended accordingly.

Event Description

Immobilized; walking difficulty [mobility decreased] septic arthritis of right knee [arthritis septic] ([staphylococcal infection]) hearing loss was worse after the antibiotic treatment [hearing loss bilateral] ([condition aggravated]) total bilirubin increased [bilirubin increased] red blood cell count decreased [red blood cell count decreased] mean corpuscular volume increased [mean corpuscular volume increased] mean cell hemoglobin increased [mean cell hemoglobin increased] neutrophil percentage increased [neutrophil percentage increased] lymphocyte percentage decreased [lymphocyte percentage decreased] lymphocyte count decreased [lymphocyte count decreased] platelet count decreased [platelet count decreased] serum potassium decreased [serum potassium decreased] blood urea nitrogen increased [blood urea nitrogen increased] elevated d-dimer [fibrin d dimer increased] swelling in both legs [swelling of legs] urinary tract infection [urinary tract infection] edema right knee [edema knees] unable to control bladder [loss of bladder sensation] fever [fever] chills [chills] dark urine [urine discoloration] moderate ecchymasis left knee [ecchymosis injection site] effusion of left elbow [effusion of elbow] pain in right knee [pain in knee] swelling in right knee/swollen to size of volleyball [swelling of r knee] knee effusion [effusion (r) knee] stress right knee [stiff knees] rt knee red [injection site joint redness] heat [joint warmth].Case narrative: based on the information received on 11-sep-2018 the case became medically confirmed.Upon internal review the case upgraded from non-valid to valid as new events were added.Initial information received on 09-aug-2018 and 15-aug-2018 was processed together regarding an unsolicited serious legal case from united states received from a consumer.This case involves a 67 years old male patient who experienced septic arthritis of right knee, immobilized, moderate ecchymasis left knee, pain in right knee, swelling in right knee/swollen to size of volleyball, rt knee red, edema right knee, stress right knee and knee effusion (latency: unknown), total bilirubin increased, red blood cell count decreased, heat, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased (latency: 3 days), swelling in both legs, effusion of left elbow and elevated d-dimer (latency: unknown), fever, chills, dark urine, unable to control bladder, urinary tract infection, hearing loss was worse after the antibiotic treatment while he was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc) and vancomycin.The past medical history included right eye red, increased cholesterol, depression, stress fractures (possible at third metatarsal), wheelchair user, left foot problem/pain, diffuse edema in foot, gout in his heels, peroneus longus tendon repair due to rupture (sesamoid fracture adjacent to the cuboid), walking aid user (crutches), foot inversion injury on (b)(6) 2003, stroke, bladder problems, popping sensation in elbow (once a day when he reaches full extension), memory loss, convulsions, impairment of balance, hearing loss, sexual dysfunction, hypersomnolence, abnormal heart rhythm, spinal stenosis, decreased hearing, feet swelling, on (b)(6) 2003 dexa scan which revealed no significant evidence of osteopenia or osteoporosis, cardiac pacemaker insertion on (b)(6) 2014, seizure (last episode on (b)(6) 2013), hypersensitive heart disease with heart failure on (b)(6) 2017, obstructive sleep apnea from (b)(6) 2017 (patient was wearing (positive airway pressure) pap every night), gastrooesophageal reflux disease without esophagitis on (b)(6) 2017migraine, back problems, kidney stone, osteoporosis, head pain, head collision, lower bilateral extremities pain, fell added.Family history of hypertension, heart disease, stroke, copd and arthritis joint, cardiomyopathy, pneumonia, pneumonia (trouble with short and long term memory), tremors, trouble with balance/gait, shuffling feet, intermittent headache, shortness of breath, large hematoma of left arm bicep, change in vision, thoracic spondylosis right groin pain, bilateral renal cysts (including large cyst in right kidney measuring up to 10.7 cm), flu shot in (b)(6) 2017, patient's temperature that night it was 100.Patient got a shot of rocephin and levaquin.Patient also had fevers to 101 and continued to get worse.The patient's concurrent conditions included at the time of the event, the patient had ongoing elbow tendonitis in 2018, chronic atrial fibrillation, hypertension, fentanyl allergy, chronic peroneal tendon synovitis, chronic pain to neck, chronic pain to lower back, chronic pain to rt shoulder , varicose veins for which symptoms include mild edema and some leg pain, aggravated by prolonged standing, chest pain, chronic fatigue, daytime somnolence, hyperlipidemia, right leg with painful varicose veins, allergy with codeine, allergy to norco, allergy to pravastatin sodium and atorvastatin calcium with side effect of myalgias.The patient was a non-tobacco user and abstained from alcohol at the time of this report.Surgical history included left ankle surgery (b)(6) 2003), cholecystectomy (gall bladder removed), total knee arthroplasty on (b)(6) 2005, patellectomy, appendectomy, rotator cuff repair, knee replacement, orthopedic surgeries, shoulder surgery bilaterally, eye surgery, bil rotator cuff, left foot surgery, cardioversion in (b)(6) 2014, heart catheterization on (b)(6) 2014, right heart catheterization with on (b)(6) 2017, knee surgery on (b)(6) 2017.Patient's mother, two sisters and brother had history of coronary artery disease, father had history of kidney failure, two sisters and brother also had history of osteopenia, hypertension, heart disease, stroke, copd.Concomitant medications included meloxicam; amlodipine besylate (amlodipine besylate); aacetylsalicylic acid (aspirin); ondansetron, oseltamivir, piperacillin sodium, tazobactam sodium (zosyn), cyanocobalamin (cyanocobalamin); fish oil (omega 3 fish oils); rivaroxaban (xarelto); trazodone hcl (trazodone hcl); levetiracetam (levetiracetam); calcium carbonate, colecalciferol (calcium carbonate with d3); ubidecarenone; ezetimibe (zetia); primidone; methocarbamol; spironolactone; valsartan (valsartan); omeprazole (prilosec), bisoprolol fumarate; furosemide (lasix); clonazepam; glycopyrrolate; oxycodone; betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); and hydrochlorothiazide, amlodipine besilate (norvasc), levetiracetam (keppra), trazodone hydrochloride (desryl), meloxicam (mobic), fish oil, testosterone cipionate ,potassium chloride and nystatin.On(b)(6) 2017, the patient received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown dose once (lot - unknown) for arthritis.On an unknown date in 2017, the patient developed septic arthritis of right knee (arthritis bacterial) and was treated with 6 weeks of vancomycin (dose, form, route, frequency: not provided).The patient reported that after the injection his right knee was swollen to the size of a volleyball and his rt knee red (latency: unknown) and heat (latency: unknown).It was reported that the patient had a staph infection of right knee and had knee replacement surgery.On (b)(6) 2017 after a latency of 3 days total bilirubin was 1.9 mg/dl, red blood cell count was 4.49x10e6/ml, mean corpuscular volume was 101.2 fl, mean cell hemoglobin was 35.2 %, neutrophil percentage was 75.5%, lymphocyte percentage was 13%, lymphocyte count was 0.70x10e3/ul, platelet count was 118x10e3/ul, serum potassium was 3.4mmol/l and blood urea nitrogen was 22mg/dl.This event was leading to intervention.The patient was hospitalized for this event, adverse event nos, was immobilized (mobility decreased), had moderate ecchymasis left knee, pain in right knee (arthralgia), swelling in right knee (joint swelling), edema right knee (oedema peripheral), stress right knee (joint stiffness) and knee effusion (joint effusion).On (b)(6) 2017, relevant laboratory test results included blood albumin 3.4 g/dl [low], blood bilirubin 1.9 mg/dl [high], lymphocyte percentage decreased 13 % [low], blood potassium 3.2 mmol/l [low], carbon dioxide increased 32 mg/dl [high], neutrophil percentage increased 75.5 % [high], platelet count decreased 126 10*3/ml [low], mean cell volume 99.5 fl [high], red blood cell count decreased 4.45 10*6/ml [low]; on (b)(6) 2017 labs included: blood glucose 134 mg/dl [high], carbon dioxide increased 32 mg/dl [high]; mean cell haemoglobin 34.6 pg [high].On (b)(6) 2017, the patient reported no falls, good appetite and normal bowel movements.On (b)(6) 2017, patient reported to the clinic for follow up of his chronic pain to neck, lower back and rt shoulder and rated it 5 on a scale of 10.He stated that his pain aggravated upon bending, lifting, prolong sitting and standing.Patient mentioned that he had constant aching radiating lower back pain, which was more on the right and extended till his feet.As a corrective for the same, patient took oxycodone and robaxin.On (b)(6) 2017, labs were blood urea 24 mg/dl, mean cell haemoglobin 34.6 pg [high], platelet count decreased was 146 10*3/ml [low]; red blood cell count decreased 4.6 10*6/ml [low], white blood cell count decreased 4.6 10*3/ml [low].The patient was put on 6-week iv antibiotic therapy.On (b)(6) 2017, labs were blood urea was 23 mg/dl [high]; carbon dioxide was 33 mg/dl [high], creatinine urine was 1.24 mg/dl [high], glomerular filtration rate 58 ml/min [low]; hematocrit was 41.8 % [low].A surgery was performed to correct septic arthritis.The patient was using a rolling walker for ambulation.The surgical wound was dressed on regular basis.The patient tolerated the whole procedure well.Patient had to use brace.On (b)(6) 2018, patient was unable to control bladder (latency: 3 months 27 days).On (b)(6) 2018, patient developed a fever (latency: 4 months) of 102 at night.On (b)(6) 2018, patient reported to the clinic with complaints of chills (latency: 4 months 1 day) and dark urine (latency: 4 months 1 day).Further, urine analysis of the patient was performed which confirmed urinary tract infection (latency: 4 months 1 day) and patient was prescribed rocephin, cipro and pyridium as a corrective for it.Further, the patient was advised to increase intake of oral fluids and to follow up if his condition worsened.On (b)(6) 2018, patient reported again for follow up of his chronic pain to neck, lower back and rt shoulder and rate it 6 on a scale of 10.The patient stated that his pain continued to hurt daily.On (b)(6) 2018, patient reported issues with swelling of both legs and effusion of right elbow (onset and latency: unknown).On (b)(6) 2018, patient reported for follow up of his chronic pain and stated that his pain continues to be radiating and constant and he was doing well with the decrease in his oxycodone.On (b)(6) 2018, patient was reported to have elevated d-dimer, shortness of breath and nuclear medicine ventilation/perfusion lung scan showed low probability of acute pulmonary embolus.On (b)(6) 2018, patient reported to the clinic for follow up of his chronic pain in his lower back.The patient was using a cane for walking assistance and described it as intermittent sharp and radiating into his posterior left lower extremity, extending occasionally to his knee and foot.On (b)(6) 2018, patient returned to the clinic for follow up of his chronic pain to lower back.He reported his pain was radiating to right leg, knee and foot and he was still using a cane for walking assistance.His pain was intermittent and sharp and was now shifting to his right leg.Furrther, upon examination, he had effusion in and around his right knee.On (b)(6) 2019, patient went for evaluation of hearing loss.It was reported that the hearing loss was worse after the antibiotic treatment (onset date: unknown).Also reported that patient's post vancomycin audiogram had worsened as compared to the pre-vancomycin audiogram.Patient was also wearing bilateral hearing aids.On the same day, patient's speech audiometry results were right (ad): 55 dbhl and left ad: 50 dbhl compared to the audiogram of (b)(6) 2016 (right ear: 68% and left ear at 76% at 80 db).Patient was also offered to visit cochlear transplant surgeon.Action taken for vancomycin was unknown.Corrective: vancomycin (vancomycin) for arthritis bacterial and ceftriaxone (ceftriaxone) and total knee replacement for arthritis bacterial and staph infection of right knee.Use of rolling walker for immobilized; walking difficulty; not reported for swelling in both legs, effusion of left elbow and elevated d-dimer; rocephin, cipro and pyridium for urinary tract infection; not reported for rest.Outcome: not recovered for hearing loss was worse after the antibiotic treatment, total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased; unknown for rest of the events.Seriousness criteria: hospitalization and intervention required for septic arthritis of right knee; disability for immobilized; walking difficulty; disability and medically significant for hearing loss was worse after the antibiotic treatment.A product technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc.Batch number unknown, global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was (b)(6) 2018.No safety issues were indicated in this review.Additional information was received on 22-aug-2018 in the form of investigation summary.Ptc results and number were added.Additional information was received on 11-sep-2018 from healthcare professional.Events of total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased was added.Medical history and concomitant medication was added.Clinical course was updated and text amended accordingly.Additional information was received on 06-dec-2018 from lawyer.Medical history updated.Concomitant medications updated.Events of swelling in both legs, effusion of left elbow and elevated d-dimer were added with details.Follow up information received on 13-dec-2018.No new information.Additional information received on 11-jan-2019 from the lawyer.Therapy onset dates for concomitant medications updated.Concomitant medication nystatin was added.Clinical course updated and text amended accordingly additional information received on 14-jan-2019 and 16-jan-2019 (both the information was processed together with clock start date 14-jan-2019) from lawyer.Medical history was updated.Additional symptom of staph infection of right knee was added along with details.The event of adverse event nos was deleted from the case.Clinical course updated and text amended accordingly.Follow up information received on 24-jan-2019 and 25-jan-2019 from lawyer.No new information.Additional information was received on 30-jan-2019 from lawyer.Medical history was updated.Clinical course updated.Text amended accordingly.Additional information received on 11-feb-2019 from lawyer.Medical history of wheelchair user, right eye red, increased cholesterol, depression added.Surgical history of bil rotator cuff added.Concomitant medication of oseltamivir added.Events of fever, chills, dark urine, unable to control bladder, urinary tract infection.Clinical course updated.Text amended accordingly.Additional information received on 19-feb-2019 from health care professional.Additional suspect of vancomycin was added.Additional event of hearing loss worsened after antibiotics was added along with details.Clinical course updated.Text amended accordingly.Additional information received on 05-mar-2019 from health care professional.Medical history of chronic pain to neck, chronic pain to rt shoulder, chronic pain to lower back, osteoporosis, head pain, head collision, lower bilateral extremities pain, fell added.Family history of hypertension, heart disease, stroke, copd added.Surgical history of knee surgery added.Event of rt knee red and heat added.Verbatim updated from swelling in right knee to swelling in right knee/swollen to size of volleyball.Clinical course updated.Text amended accordingly.

Event Description

Immobilized/walking difficulty [mobility decreased].Slow cadence [walking difficulty] ([pain upon movement]).Septic arthritis of right knee [arthritis septic] ([staphylococcal infection]).Hearing loss was worse after the antibiotic treatment [hearing loss bilateral].([condition aggravated]).Total bilirubin increased [bilirubin increased].Red blood cell count decreased [red blood cell count decreased].Mean corpuscular volume increased [mean corpuscular volume increased].Mean cell hemoglobin increased [mean cell hemoglobin increased].Neutrophil percentage increased [neutrophil percentage increased].Lymphocyte percentage decreased [lymphocyte percentage decreased].Lymphocyte count decreased [lymphocyte count decreased].Serum potassium decreased [serum potassium decreased].Blood urea nitrogen increased [blood urea nitrogen increased].Elevated d-dimer [fibrin d dimer increased].Urinary tract infection [urinary tract infection].Unable to control bladder [loss of bladder sensation].Co2 high [carbon dioxide high].Sensorimotor peripheral neuropathy [peripheral sensorimotor neuropathy] ([numbness in feet], [tingling sensation]).Off balance at times [balance disorder].Dark urine [urine discoloration].Total protein high [total protein high].Bun (blood urea nitrogen) high [blood urea nitrogen increased].Effusion of left elbow [effusion of elbow].Edema right knee/ fluctuating knee edema/edema left knee [edema knees].Platelet count decreased [platelet count decreased].Chills [chills].Fever [fever].Swelling in both legs [swelling of legs].Moderate ecchymasis left knee/ecchymosis left distal hamstring/popliteal fossa [ecchymosis injection site].Pain in right knee/tenderness anterior knee/arthritic pain right knee [aching (r) knee].([pain upon movement]).Swelling in right knee/swollen to size of volleyball [swelling of r knee].Knee effusion [effusion (r) knee].Stress right knee [stiff knees].Rt knee red [injection site joint redness].Heat [joint warmth].Lipoma back of neck [lipoma] ([local swelling]).Intermittent pain [pain].Case narrative: based on the information received on 11-sep-2018, case became medically confirmed.Upon internal review the case upgraded from non-valid to valid as new events were add.Initial information received on 09-aug-2018 and 15-aug-2018 ws processed together regarding an unsolicited serious valid legal case from united states received from a lawyer.This case involves a 67 years old male patient (183 cm and 94 kg) who experienced immobilized/walking difficulty, slow cadence, septic arthritis of right knee, hearing loss ws worse after the antibiotic treatment, total bilirubin increased (inc), red blood cell count decreased (dec), mean corpuscular volume inc, mean cell hemoglobin inc, neutrophil percentage inc, lymphocyte percentage dec, lymphocyte count dec, platelet count dec, serum potassium dec, blood urea nitrogen inc, elevated d-dimer, swelling in both legs, urinary tract infection, edema right knee/ fluctuating knee edema/edema left knee, unable to control bladder, fever, chills, dark urine, effusion of left elbow, moderate ecchymasis left knee/ecchymosis left distal hamstring/popliteal fossa, pain in right knee/tenderness anterior knee/arthritic pain right knee, swelling in right knee/swollen to size of volleyball, knee effusion, stress right knee, rt knee red, heat, co2 high, sensorimotor peripheral neuropathy, off balance at times, total protein high, lipoma back of neck and intermittent pain and bun (blood urea nitrogen) high while he ws treated with hylan g-f 20, sodium hyaluronate (synvisc) and vancomycin.Medical history: cardiomyopathy-non ischemic, right sided chf, tricuspid regurgitation mild to moderate, patent foramen ovale, right eye red, mva (motor vehicle accident), bilateral knee flexion limited, inc cholesterol, depression, stress fractures (possible at third metatarsal), wheelchair user, left foot problem/pain, diffuse edema in foot, gout in his heels, peroneus longus tendon repair due to rupture (sesamoid fracture adjacent to the cuboid), walking aid user (crutches), patellectomy, foot inversion injury on (b)(6) 2003, stroke, bladder problems, popping sensation in elbow (once a day when he reaches full extension), memory loss, convulsions, impairment of balance, hearing loss (disability and medically significant), sexual dysfunction, hypersomnolence, irritable bowel syndrome, overweight, chronic insomnia disorder, essential tremor, anxiety, no caffeine use, no drug use, abnormal heart rhythm, spinal stenosis, dec hearing, feet swelling, on (b)(6) 2003 dexa scan revealed no significant evidence of osteopenia or osteoporosis, cardiac pacemaker insertion on (b)(6) 2014, seizure disorder (last episode on (b)(6) 2013), hypersensitive heart disease with heart failure on (b)(6) 2017, obstructive sleep apnea from on (b)(6) 2017 (used positive airway pressure every night), gastrooesophageal reflux disease without esophagitis on (b)(6) 2017, migraine, back problems, kidney stone, osteoporosis, head pain, head collision, lower bilateral extremities pain, fell.Copd and arthritis joint, pneumonia, pneumonia (trouble with short and long term memory), tremors, trouble with balance/gait, shuffling feet, intermittent headache, shortness of breath, large hematoma of left arm bicep, change in vision, thoracic spondylosis right groin pain, bilateral renal cysts (including large cyst in right kidney measuring up to 10.7 cm), flu shot on (b)(6) 2017.Concurrent conditions: elbow tendonitis in 2018, chronic atrial fibrillation (on (b)(6) 2014), hypertension, fentanyl allergy, chronic peroneal tendon synovitis, chronic pain to neck, chronic pain to lower back, chronic pain to rt shoulder, varicose veins for which symptoms include mild edema and some leg pain, arthritis, aggravated by prolonged standing, chest pain, chronic fatigue, daytime somnolence, hyperlipidemia, right leg with painful varicose veins, allergy with codeine, allergy to norco, allergy to pravastatin sodium and atorvastatin calcium with side effect of myalgias, sinusitis, drug allergy, vocal cord surgery, cataract removal, dizziness, vestibular neuronitis, congestion for left ear, fever, vertigo, decrease in hearing, abrasion of right ear canal, sensorineural hearing loss, hearing aid, superficial mycosis, nasal congestion, allergic rhinitis, dysphagia, throat pain, swelling, mass or lump in head and neck, acute upper respiratory infections of unspecified site, difficulty talking.Non-tobacco user, abstained from alcohol.The patient ws a former smoker.Surgical history: lumpectomy, prostate surgery, patellectomy (1975) left ankle surgery (on (b)(6) 2003), cholecystectomy (gall bladder removed), total knee arthroplasty on (b)(6) 2005, patellectomy, appendectomy, rotator cuff repair, knee replacement, orthopedic surgeries, shoulder surgery bilaterally, eye surgery, bil rotator cuff, left foot surgery, cardioversion on (b)(6) 2014, heart catheterization on (b)(6) 2014, right heart catheterization with on (b)(6) 2017, knee surgery on (b)(6) 2017 and fiberoptic laryngoscopy.Family history: mother, two sisters and brother: coronary artery disease, mother: heart attack and heart condition, sibling: lung disease, sleep apnea/ snoring, depression, smoking, cancer, father: kidney failure, two sisters and brother: osteopenia, hypertension, heart disease/heart trouble, stroke, copd, alzheimers disease, arthritis, benign essential tumor: sister and son.Concomitant medications: meloxicam; amlodipine besylate; aspirin; zosyn, cyanocobalami; fish oil; xarelto; trazodone hcl; levetiracetam; calcium carbonate with d3; ubidecarenone; zetia; primidone; methocarbamol; spironolactone; valsartan; prilosec, lasix; clonazepam; glycopyrrolate; oxycodone; betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); hydrochlorothiazide, norvasc, keppra, desryl, mobic, testosterone cipionate, potassium chloride, nystatin, fluticasone propionate, glycopyrronium bromide (robinul), ciprofloxacin hydrochloride, vitamin b12, lexapro and bystolic, robaxin 750, co q-10, calcium 600+d3, bisoprolol 10 mg-hydrochlorothiazide 6.25 mg, irbesartan, omeprazole delayed release.On (b)(6) 2017, pt received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown (unk) dose once (lot - unk) for arthritis.On an unk date in 2017, pt developed septic arthritis of right knee (arthritis bacterial) (hospitalization, medically significant and intervention required) and ws treated for 6 weeks with vancomycin (dose, form, route, frequency: not provided).After the injection, his right knee ws swollen to the size of a volleyball and rt knee red (latency: unk), heat (latency: unk).Pt had a staph infection of right knee and had knee replacement surgery.On (b)(6) 2017 after a latency of 3 days total bilirubin ws 1.9 mg/dl, red blood cell count ws 4.49x10e6/ml, mean corpuscular volume ws 101.2 fl, mean cell hemoglobin ws 35.2 %, neutrophil percentage ws 75.5%, lymphocyte percentage ws 13%, lymphocyte count ws 0.70x10e3/ul, platelet count ws 118x10e3/ul, serum potassium ws 3.4mmol/l and blood urea nitrogen ws 22mg/dl.This event ws leading to intervention.On the same day, diagnosed with septic arthritis of right knee (hospitalized), immobilized (mobility dec) (disability), moderate ecchymasis left knee, pain in right knee, swelling in right knee, edema right knee, stress right knee and knee effusion.On (b)(6) 2017, blood albumin 3.4 g/dl (low) (l), blood bilirubin 1.9 mg/dl (high) (h), lymphocyte percentage dec 13 % (l), blood potassium 3.2 mmol/l (l), carbon dioxide inc 32 mg/dl [high], neutrophil percentage inc 75.5 % (h), platelet count dec 126 10e3/ml (l), mean cell volume 99.5 fl (h), red blood cell count dec 4.45 10e6/ml (l); on (b)(6) 2017, blood glucose 134 mg/dl (h), carbon dioxide inc 32 mg/dl (h); mean cell haemoglobin 34.6 pg [high].On (b)(6) 2017, follow up for chronic pain to neck, lower back, rt shoulder and rated it 5/10.Pain aggravated upon bending, lifting, prolong sitting and standing.Constant aching radiating lower back pain, more on the right and extended till his feet.On (b)(6) 2017, blood urea 24 mg/dl, mean cell haemoglobin 34.6 pg (h), platelet count dec ws 146 10e3/ml (l); red blood cell count dec 4.6 10e6/ml (l), white blood cell count dec 4.6 10e3/ml (l).On (b)(6) 2017, blood urea ws 23 mg/dl (h); carbon dioxide ws 33 mg/dl (h), creatinine urine ws 1.24 mg/dl (h), glomerular filtration rate 58 ml/min (l); hematocrit ws 41.8 % (l).A surgery ws performed to correct septic arthritis.Used rolling walker for ambulation, brace.On (b)(6) 2018, unable to control bladder (3 months 27 days).On (b)(6) 2018, fever (4 months) of 102 at night.On (b)(6) 2018, after 4 months 1 day, complaints of chills, dark urine.Urine analysis confirmed urinary tract infection.Pt advised to increase intake of oral fluids.On (b)(6) 2018, follow up of his chronic pain to neck, lower back, rt shoulder, rate it 6 on a scale of 10.Pain continued to hurt daily.On (b)(6) 2018, issues with swelling of both legs and effusion of right elbow (onset and latency: unk).Same day, ecg showed v paced rhythm.On (b)(6) 2018, pt reported for follow up of his chronic pain and stated that his pain radiating, constant.On (b)(6) 2018, glucose 114 mg/dl (70-100) (h), bun (blood urea nitrogen) 24 mg/dl (7-21) (h), co2 34 mmol/l (h), total protein 6.2 g/dl (6.4-8.3) (l).On (b)(6)2018, after 9 months 12 days latency, d-dimer assay 0.61 ug/ml (0-0.42) (h).On (b)(6) 2018, elevated d-dimer, shortness of breath, nuclear medicine ventilation/perfusion lung scan showed low probability of acute pulmonary embolus.Same day, cxr showed no acute abnormality, vq scan show low probability for acute pulmonary embolus.On (b)(6) 2018, used a cane for walking assistance, pain intermittent sharp, radiating into his posterior left lower extremity, extending occasionally to his knee and foot.On (b)(6) 2018, was still using a cane for walking assistance, pain was now shifting to his right leg, had effusion in and around his right knee.On (b)(6) 2019, evaluation of hearing loss.The hearing loss ws worse after the antibiotic treatment (onset date: unk).Post vancomycin audiogram had worsened.Wore bilateral hearing aids.Same day, speech audiometry results were right (ad): 55 dbhl and left ad: 50 dbhl compared to the audiogram on (b)(6)2016 (right ear: 68% and left ear at 76% at 80 db).On (b)(6) 2018, lifted his leg and felt pop with inc pain, diagnosed with slow cadence (disability), ambulating with assistance, tenderness in anterior knee and fluctuating knee edema.On (b)(6) 2018, tolerated pain well.On (b)(6) 2018, pts balance strength inc.On (b)(6) 2018, minimal edema observed in the right knee.On (b)(6) 2018, inc quadricep exercise and had 0/10 knee pain.On (b)(6) 2018, 5/10 right knee pain after doing wall slides.On (b)(6) 2018, significant edema in the left knee localized to joint capsule.On (b)(6) 2018, severe ecchymosis left distal hamstring/popiteal fossa.On (b)(6) 2018, increase quadriceps and balance exercises.On (b)(6) 2018, doing well.On (b)(6) 2018, balance improved with gait.On (b)(6) 2018, had good effort with exercises.On (b)(6) 2018, balance was improved with gait.On (b)(6) 2018, 4/10 bilateral knee pain ambulating while extended distance.On (b)(6) 2018, his balance with gait was improved, quadricep exercises were inc.On (b)(6) 2018, dec in right knee edema.On (b)(6) 2019, doing well.On (b)(6) 2019, right knee pain with standing.On (b)(6) 2019, he had first arthritic pain right knee, frustrated by continuous pain.On (b)(6) 2019, 98.7% ventricular pacing was observed.On (b)(6) 2019, ecg showed left ventricle (lv) wall thickness mildly inc, lv ejection fraction 58%, left to right shunting with qp/qs 0.814, right ventricular dysfunction, left atrium severely dilated, left atrial volume severely dilated, mild to moderate tricuspid regurgitation, no significant changes since last study.On (b)(6) 2019, good efforts with quadriceps exercise, knee pain in last 2-3 days.On (b)(6) 2019, follow up for chronic atrial fibrillation, had obstructive apnea which was a contributory factor.No pericardial effusion.On (b)(6) 2019, inc resistance with quadriceps strengthening.On (b)(6) 2019, complain of obstructive apnea which he had for years.Excessive daytime sleepiness described as moderate, insomnia which ws well controlled, told to use a new mask or machine.On (b)(6) 2019, quadricep balance was inc, good tolerance.On (b)(6) 2019, fluid gait with quadriceps, fluctuating pain with gait.On (b)(6) 2019, strength and balance improved.On (b)(6) 2019, pain was 3/10.On (b)(6) 2019, review of several symptoms including headache.No significant problem, very pleased with his improved control.Lab results: co2 was 34 mmol/l (21-31) (high), same day, underwent neurodiagnostic study which was abnormal, the nerve conduction of lower extremities, selective emg was consistent with sensorimotor peripheral neuropathy (latency:1 year 8 months 7 days).Pts tremors had improved, his memory loss was fairly stable, not had any seizures since past visit, used a cane, had no recent falls but he did feel off balance at times (latency: 1 year 8 months 7 days).Pt struggling with numbness and tingling in his feet, he stated that he had some burning discomfort at times and symptoms were worse at night.Lost 5 pounds, working towards losing weight.Continued keppra for tremors and ws told to get tests done for his neuropathy.On (b)(6) 2019, patient visited doctor with c/o neck lipoma and had intermittent pain for several months.The assessment revealed localized swelling, mass, lump, trunk with supple neck and bony prominence which was believed to be t1 spinous process and not lipoma.On (b)(6) 2020, headache had improved, his seizures continued to be problematic, but he had managed his tremors.Pts tremors caused him problems with pouring his coffee, he used primidone for it.Used a cane and felt off balance at times.Lab results were good except b12, which ws low, taking supplements.Quality of life measures and excessive daytime sleepiness assessed using epworth sleepiness scale.Counseling and lifestyle education regarding diet and exercises, follow up in 6 months.On (b)(6) 2020, pt underwent the implanted pacemaker review which showed 5 episodes of ventricular high rate.Action taken: unk for vancomycin; not applicable for hylan g-f 20, sodium hyaluronate.Corrective: vancomycin for arthritis bacterial; ceftriaxone, total knee replacement for arthritis bacterial and staph infection of right knee; rolling walker for immobilized; walking difficulty; rocephin, cipro, pyridium for urinary tract infection; not reported for rest.Outcome: not recovered for off balance at times, immobilized/walking difficulty, co2 high, hearing loss ws worse after the antibiotic treatment, total bilirubin inc, red blood cell count dec, mean corpuscular volume inc, mean cell hemoglobin inc, neutrophil percentage inc, lymphocyte percentage dec, lymphocyte count dec, platelet count dec, serum potassium dec and blood urea nitrogen inc; pain in right knee/tenderness anterior knee/arthritic pain right knee; recovering for slow cadence, edema right knee/ fluctuating knee edema/edema left knee; unk for rest of the events.A product technical complaint (ptc) ws initiated on 22-aug-2018 for synvisc.Batch number: unk, global ptc number: 55125.The product lot number ws not provided; therefore, a batch record review ws not possible.Based on the lack of information provided, no capa ws required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date ws 22-aug-2018.Additional information ws received (air) on 22-aug-2018.Ptc results and number were add.Air on 11-sep-2018 healthcare professional (hcp).Events total bilirubin inc, red blood cell count dec, mean corpuscular volume inc, mean cell hemoglobin inc, neutrophil percentage inc, lymphocyte percentage dec, lymphocyte count dec, platelet count dec, serum potassium dec, and blood urea nitrogen inc add.Medical history, con meds add.Air on 06-dec-2018 lawyer.Medical history, con meds updated.Events swelling in both legs, effusion of left elbow, elevated d-dimer add.Air 13-dec-2018.No new information (nni).Air 11-jan-2019 the lawyer.Con meds updated.Air on 14-jan-2019 and 16-jan-2019 (csd 14-jan-2019) from lawyer.Medical history updated.Staph infection of right knee add, adverse event nos deleted.Air on 24-jan-2019 and 25-jan-2019 from lawyer.Nni.Air on 30-jan-2019 lawyer.Medical history updated.Air on 11-feb-2019 lawyer.Medical history, surgical history, con meds add.Events of fever, chills, dark urine, unable to control bladder, urinary tract infection.Air on 19-feb-2019 hcp.Suspect vancomycin add.Event of hearing loss worsened after antibiotics add.Air on 05-mar-2019 hcp.Medical, family, surgical history add.Event of rt knee red, heat add.Verbatim updated from swelling in right knee to swelling in right knee/swollen to size of volleyball.Air on 24-apr-2019 lawyer.Medical history.Slow cadence add.Verbatim for pain in right knee ws updated to pain in right knee/tenderness anterior knee/arthritic pain right knee.Edema right knee updated to edema right knee/ fluctuating knee edema/ edema left knee.Outcome updated.Onset date for the event of septic arthritis of right knee add.Air on 26-apr-2019 lawyer.Medical history, con meds updated.Air on 17-jan-2020 lawyer.Medical history of irritable bowel syndrome, overweight, chronic insomnia disorder, essential tremor, anxiety, no caffeine use, no drug use.Family history of alzheimers disease, arthritis, benign essential tumor add.Surgical history of lumpectomy, prostate surgery add.Patients weight updated.Events of co2 high, sensorimotor peripheral neuropathy with symptom of numbness and tingling in his feet, off balance at times.Outcome updated to not recovered for immobilized/walking difficulty.Air on 22-jan-2020 lawyer.Lab test results of ecg add.Medical history of cardiomyopathy-non ischemic, right sided chf, tricuspid regurgitation mild to moderate, patent foramen ovale, seizure disorder.Details pertaining to patients history of chronic atrial fibrillation add.Events of total protein high and bun (blood urea nitrogen) high add.Event onset date updated for elevated d-dimer.Air 28-jan-2020 lawyer.Event add lipoma, intermittent pain.Concomitant medications add.

Event Description

Immobilized/walking difficulty [mobility decreased].Slow cadence [walking difficulty] ([pain upon movement]).Septic arthritis of right knee [arthritis septic] ([staphylococcal infection]).Hearing loss was worse after the antibiotic treatment [hearing loss bilateral].([condition aggravated]).Total bilirubin increased [bilirubin increased].Red blood cell count decreased [red blood cell count decreased].Mean corpuscular volume increased [mean corpuscular volume increased].Mean cell hemoglobin increased [mean cell hemoglobin increased].Neutrophil percentage increased [neutrophil percentage increased].Lymphocyte percentage decreased [lymphocyte percentage decreased].Lymphocyte count decreased [lymphocyte count decreased].Platelet count decreased [platelet count decreased].Serum potassium decreased [serum potassium decreased].Blood urea nitrogen increased [blood urea nitrogen increased].Elevated d-dimer [fibrin d dimer increased].Swelling in both legs [swelling of legs].Urinary tract infection [urinary tract infection].Edema right knee/ fluctuating knee edema/edema left knee [edema knees].Unable to control bladder [loss of bladder sensation].Fever [fever].Chills [chills].Co2 high [carbon dioxide high].Sensorimotor peripheral neuropathy [peripheral sensorimotor neuropathy] ([numbness in feet], [tingling sensation]).Off balance at times [balance disorder].Dark urine [urine discoloration].Effusion of left elbow [effusion of elbow].Moderate ecchymasis left knee/ecchymosis left distal hamstring/popliteal fossa [ecchymosis injection site].Pain in right knee/tenderness anterior knee/arthritic pain right knee [pain in knee] ([pain upon movement]).Swelling in right knee/swollen to size of volleyball [swelling of r knee].Knee effusion [effusion (r) knee].Stress right knee [stiff knees].Rt knee red [injection site joint redness].Heat [joint warmth].Case narrative: based on the information received on 11-sep-2018 the case became medically confirmed.Upon internal review the case upgraded from non-valid to valid as new events were added.Initial information received on 09-aug-2018 and 15-aug-2018 was processed together regarding an unsolicited serious valid legal case from united states received from a lawyer.This case involves a 67 years old male patient (183 cm and 94 kg) who experienced immobilized/walking difficulty, slow cadence, septic arthritis of right knee, hearing loss was worse after the antibiotic treatment, total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased, blood urea nitrogen increased, elevated d-dimer, swelling in both legs, urinary tract infection, edema right knee/ fluctuating knee edema/edema left knee, unable to control bladder, fever, chills, dark urine, effusion of left elbow, moderate ecchymasis left knee/ecchymosis left distal hamstring/popliteal fossa, pain in right knee/tenderness anterior knee/arthritic pain right knee, swelling in right knee/swollen to size of volleyball, knee effusion, stress right knee, rt knee red, heat, co2 high, sensorimotor peripheral neuropathy and off balance at times, while he was treated with hylan g-f 20, sodium hyaluronate (synvisc) and vancomycin.Past medical history: right eye red, mva (motor vehicle accident), bilateral knee flexion limited, increased cholesterol, depression, stress fractures (possible at third metatarsal), wheelchair user, left foot problem/pain, diffuse edema in foot, gout in his heels, peroneus longus tendon repair due to rupture (sesamoid fracture adjacent to the cuboid), walking aid user (crutches), patellectomy, foot inversion injury on (b)(6)2003, stroke, bladder problems, popping sensation in elbow (once a day when he reaches full extension), memory loss, convulsions, impairment of balance, hearing loss (disability and medically significant), sexual dysfunction, hypersomnolence, irritable bowel syndrome, overweight, chronic insomnia disorder, essential tremor, anxiety, no caffeine use, no drug use, abnormal heart rhythm, spinal stenosis, decreased hearing, feet swelling, (b)(6)2003 dexa scan revealed no significant evidence of osteopenia or osteoporosis, cardiac pacemaker insertion on (b)(6)2014, seizure (last episode on (b)(6)2013), hypersensitive heart disease with heart failure on (b)(6)2017, obstructive sleep apnea from (b)(6)2017 (used positive airway pressure every night), gastrooesophageal reflux disease without esophagitis on (b)(6)2017, migraine, back problems, kidney stone, osteoporosis, head pain, head collision, lower bilateral extremities pain, fell added.Family history of hypertension, heart disease, stroke, copd and arthritis joint, cardiomyopathy, pneumonia, pneumonia (trouble with short and long term memory), tremors, trouble with balance/gait, shuffling feet, intermittent headache, shortness of breath, large hematoma of left arm bicep, change in vision, thoracic spondylosis right groin pain, bilateral renal cysts (including large cyst in right kidney measuring up to 10.7 cm), flu shot in (b)(6)2017.Concurrent conditions: elbow tendonitis in 2018, chronic atrial fibrillation, hypertension, fentanyl allergy, chronic peroneal tendon synovitis, chronic pain to neck, chronic pain to lower back, chronic pain to rt shoulder, varicose veins for which symptoms include mild edema and some leg pain, aggravated by prolonged standing, chest pain, chronic fatigue, daytime somnolence, hyperlipidemia, right leg with painful varicose veins, allergy with codeine, allergy to norco, allergy to pravastatin sodium and atorvastatin calcium with side effect of myalgias, sinusitis, drug allergy, vocal cord surgery, cataract removal, dizziness, vestibular neuronitis, congestion for left ear, fever, vertigo, decrease in hearing, abrasion of right ear canal, sensorineural hearing loss, hearing aid, superficial mycosis, nasal congestion, allergic rhinitis, dysphagia, throat pain, swelling, mass or lump in head and neck, acute upper respiratory infections of unspecified site, difficulty talking.Non-tobacco user, abstained from alcohol.Surgical history: lumpectomy, prostate surgery, patellectomy (1975) left ankle surgery ((b)(6)2003), cholecystectomy (gall bladder removed), total knee arthroplasty on (b)(6)2005, patellectomy, appendectomy, rotator cuff repair, knee replacement, orthopedic surgeries, shoulder surgery bilaterally, eye surgery, bil rotator cuff, left foot surgery, cardioversion in (b)(6)2014, heart catheterization on (b)(6)2014, right heart catheterization with on (b)(6)2017, knee surgery on (b)(6)2017 and fiberoptic laryngoscopy.Family history: mother, two sisters and brother: coronary artery disease, mother: heart attack and heart condition, sibling: lung disease, sleep apnea/ snoring, depression, smoking, cancer, father: kidney failure, two sisters and brother: osteopenia, hypertension, heart disease, stroke, copd, alzheimers disease, arthritis, benign essential tumor: sister and son.Concomitant medications: meloxicam; amlodipine besylate (amlodipine besylate); aacetylsalicylic acid (aspirin); ondansetron, oseltamivir, piperacillin sodium, tazobactam sodium (zosyn), cyanocobalamin (cyanocobalamin); fish oil (omega 3 fish oils); rivaroxaban (xarelto); trazodone hcl (trazodone hcl); levetiracetam (levetiracetam); calcium carbonate, colecalciferol (calcium carbonate with d3); ubidecarenone; ezetimibe (zetia); primidone; methocarbamol; spironolactone; valsartan (valsartan); omeprazole (prilosec), bisoprolol fumarate; furosemide (lasix); clonazepam; glycopyrrolate; oxycodone; betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); and hydrochlorothiazide, amlodipine besilate (norvasc), levetiracetam (keppra), trazodone hydrochloride (desryl), meloxicam (mobic), fish oil, testosterone cipionate ,potassium chloride, nystatin, fluticasone propionate, glycopyrronium bromide (robinul), ciprofloxacin hydrochloride, vitamin b12, escitalopram oxalate (lexapro) and nebivolol hydrochloride (bystolic) on (b)(6)2017, pt received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown (unk) dose once (lot - unk) for arthritis.On an unk date in 2017, pt developed septic arthritis of right knee (arthritis bacterial) (hospitalization, medically significant and intervention required) and was treated for 6 weeks with vancomycin (dose, form, route, frequency: not provided).After the injection, his right knee was swollen to the size of a volleyball and rt knee red (latency: unk), heat (latency: unk).Pt had a staph infection of right knee and had knee replacement surgery.On (b)(6)2017 after a latency of 3 days total bilirubin was 1.9 mg/dl, red blood cell count was 4.49x10e6/ml, mean corpuscular volume was 101.2 fl, mean cell hemoglobin was 35.2 %, neutrophil percentage was 75.5%, lymphocyte percentage was 13%, lymphocyte count was 0.70x10e3/ul, platelet count was 118x10e3/ul, serum potassium was 3.4mmol/l and blood urea nitrogen was 22mg/dl.This event was leading to intervention.On the same day, pt was diagnosed with septic arthritis of right knee.The pt was hospitalized for this event.Pt was immobilized (mobility decreased) (disability), had moderate ecchymasis left knee, pain in right knee (arthralgia), swelling in right knee, edema right knee, stress right knee and knee effusion.On (b)(6)2017, laboratory tests: blood albumin 3.4 g/dl [low], blood bilirubin 1.9 mg/dl [high], lymphocyte percentage decreased 13 % [low], blood potassium 3.2 mmol/l [low], carbon dioxide increased 32 mg/dl [high], neutrophil percentage increased 75.5 % [high], platelet count decreased 126 10e3/ml [low], mean cell volume 99.5 fl [high], red blood cell count decreased 4.45 10e6/ml [low]; on (b)(6)2017 labs included: blood glucose 134 mg/dl [high], carbon dioxide increased 32 mg/dl [high]; mean cell haemoglobin 34.6 pg [high].On (b)(6)2017, the pt reported no falls, good appetite and normal bowel movements.On (b)(6)2017, pt reported for follow up of his chronic pain to neck, lower back and rt shoulder and rated it 5/10.He stated that his pain aggravated upon bending, lifting, prolong sitting and standing.Pt had constant aching radiating lower back pain, which was more on the right and extended till his feet.On (b)(6)2017, labs were blood urea 24 mg/dl, mean cell haemoglobin 34.6 pg [high], platelet count decreased was 146 10e3/ml [low]; red blood cell count decreased 4.6 10e6/ml [low], white blood cell count decreased 4.6 10e3/ml [low].The pt was put on 6-week iv antibiotic therapy.On (b)(6)2017, labs were blood urea was 23 mg/dl [high]; carbon dioxide was 33 mg/dl [high], creatinine urine was 1.24 mg/dl [high], glomerular filtration rate 58 ml/min [low]; hematocrit was 41.8 % [low].A surgery was performed to correct septic arthritis.The pt was using a rolling walker for ambulation.The surgical wound was dressed on regular basis.The pt tolerated the whole procedure well.Pt had to use brace.On (b)(6)2018, pt was unable to control bladder (latency: 3 months 27 days).On (b)(6)2018, pt developed a fever (latency: 4 months) of 102 at night.On (b)(6)2018, pt reported to the clinic with complaints of chills (latency: 4 months 1 day) and dark urine (latency: 4 months 1 day).Further, urine analysis of the pt was performed which confirmed urinary tract infection (latency: 4 months 1 day).Pt advised to increase intake of oral fluids and to follow up if his condition worsened.On (b)(6)2018, follow up of his chronic pain to neck, lower back and rt shoulder and rate it 6 on a scale of 10.The pt stated that his pain continued to hurt daily.On (b)(6)2018, pt reported issues with swelling of both legs and effusion of right elbow (onset and latency: unk).On (b)(6)2018, pt reported for follow up of his chronic pain and stated that his pain continues to be radiating and constant and he was doing well with the decrease in his oxycodone.On (b)(6)2018, pt reported to have elevated d-dimer, shortness of breath and nuclear medicine ventilation/perfusion lung scan showed low probability of acute pulmonary embolus.On (b)(6)2018, follow up of his chronic pain in his lower back.The pt was using a cane for walking assistance and described it as intermittent sharp and radiating into his posterior left lower extremity, extending occasionally to his knee and foot.On (b)(6)2018, follow up of his chronic pain to lower back.He reported his pain was radiating to right leg, knee and foot and he was still using a cane for walking assistance.His pain was intermittent and sharp and was now shifting to his right leg.Further, upon examination, he had effusion in and around his right knee.On (b)(6)2019, pt went for evaluation of hearing loss.The hearing loss was worse after the antibiotic treatment (onset date: unk).Pts post vancomycin audiogram had worsened as compared to the pre-vancomycin audiogram.Pt was also wearing bilateral hearing aids.Same day, pts speech audiometry results were right (ad): 55 dbhl and left ad: 50 dbhl compared to the audiogram of (b)(6)2016 (right ear: 68% and left ear at 76% at 80 db).On (b)(6)2018, pt went to healthcare facility, pt lifted his leg and felt pop with increased pain.He was also diagnosed with slow cadence (disability), ambulating with assistance, tenderness in anterior knee and fluctuating knee edema.On (b)(6)2018, pt showed that he tolerated pain well.On (b)(6)2018, pts balance strength increased.On evaluation on (b)(6)2018, minimal edema was observed in the right knee.Pt had been aggressive in quadriceps exercises.On (b)(6)2018, pt increased quadricep exercise and had 0/10 knee pain.On (b)(6)2018, pt had 5/10 right knee pain after doing wall slides.On (b)(6)2018, pt had significant edema in the left knee localized to joint capsule.On (b)(6)2018, pt had severe ecchymosis left distal hamstring/ popiteal fossa.On (b)(6)2018, it was noted to increase quadriceps and balance exercises.On (b)(6)2018, pt was doing well.On (b)(6)2018, pts balance was improved with gait.On (b)(6)2018, pt had good effort with exercises.On (b)(6)2018, pts balance was improved with gait.On (b)(6)2018, he had 4/10 bilateral knee pain ambulating while extended distance.On (b)(6)2018, his balance with gait was improved and quadricep exercises were increased.On the evaluation on (b)(6)2018, there was decreased in right knee edema.On (b)(6)2019, pt was doing well.On (b)(6)2019, pt had right knee pain with standing.On (b)(6)2019, he had first arthritic pain right knee and he was frustrated by continuous pain.On (b)(6)2019, pt was having good efforts with quadriceps exercise and reported knee pain in last 2-3 days.On (b)(6)2019, pt was having increased resistance with quadriceps strengthening.On (b)(6)2019, present with complain of obstructive apnea which he had for years.Patient had excessive daytime sleepiness which was described as moderate and insomnia which was well controlled.Patient was told to use a new mask or machine.The patient was advised to follow up in case of any pressure problems or issues with mask or machine.On (b)(6)2019, pts quadricep balance was increased and good tolerance.On (b)(6)2019, pt had fluid gait with quadriceps.He was having fluctuating pain with gait.On (b)(6)2019, his strength and balance improved.On (b)(6)2019, pain was 3/10.On (b)(6)2019, patient reported for review of several symptoms including headache.Patient reported there was no significant problem and he was very pleased with his improved control.The lab results: co2 was 34 mmol/l (21-31) (high).The same day, pt underwent neurodiagnostic study which was abnormal, the nerve conduction of lower extremities and selective emg was consistent with sensorimotor peripheral neuropathy (latency:1 year 8 months 7 days).Pts tremors had improved, his memory loss was fairly stable, he had not had any seizures since past visit, he was using a cane, had no recent falls but he did feel off balance at times (latency: 1 year 8 months 7 days).Pt was struggling with numbness and tingling in his feet, he stated that he had some burning discomfort at times and symptoms were worse at night.Pt had lost 5 pounds and was working towards losing weight.Pt was advised to continue using keppra for his tremors and was told to get tests done for his neuropathy.On (b)(6)2020, pt followed up for medical histories of headaches, tremors, insomnia, seizures and overweight.Pts headache had improved, his seizures continued to be problematic, but he had managed his tremors.Pts tremors caused him problems with pouring his coffee, he used primidone for it which he found helpful.The patient still used a cane and felt off balance at times.Pt lab results were good except b12, which was low, taking supplements for it.Pts quality of life measures and excessive daytime sleepiness assessed using epworth sleepiness scale.Pt provided with counseling and lifestyle education regarding diet and exercises.Pt told to follow up in 6 months.Action taken: unk for vancomycin; not applicable for hylan g-f 20, sodium hyaluronate corrective: vancomycin for arthritis bacterial; ceftriaxone, total knee replacement for arthritis bacterial and staph infection of right knee; rolling walker for immobilized; walking difficulty; rocephin, cipro, pyridium for urinary tract infection; not reported for rest outcome: not recovered for off balance at times, immobilized/walking difficulty, co2 high, hearing loss was worse after the antibiotic treatment, total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased; pain in right knee/tenderness anterior knee/arthritic pain right knee; recovering for slow cadence, edema right knee/ fluctuating knee edema/edema left knee; unk for rest of the events.A product technical complaint (ptc) was initiated on 22-aug-2018 for synvisc.Batch number unk, global ptc number: 55125.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was 22-aug-2018.Additional information was received (air) on 22-aug-2018.Ptc results and number were added.Air on 11-sep-2018 from healthcare professional (hcp).Events of total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased, and blood urea nitrogen increased added.Medical history, con meds added.Air on 06-dec-2018 from lawyer.Medical history, con meds updated.Events of swelling in both legs, effusion of left elbow and elevated d-dimer were added with details.Air 13-dec-2018.No new information (nni).Air 11-jan-2019 from the lawyer.Con meds updated.Air on 14-jan-2019 and 16-jan-2019 (csd 14-jan-2019) from lawyer.Medical history updated.Additional symptom of staph infection of right knee was added along with details.The event of adverse event nos was deleted from the case.Air on 24-jan-2019 and 25-jan-2019 from lawyer.Nni.Air on 30-jan-2019 from lawyer.Medical history updated.Air on 11-feb-2019 from lawyer.Medical history, surgical history, con meds added.Events of fever, chills, dark urine, unable to control bladder, urinary tract infection.Air on 19-feb-2019 from hcp.Suspect vancomycin added.Event of hearing loss worsened after antibiotics added.Air on 05-mar-2019 from hcp.Medical, family, surgical history added.Event of rt knee red and heat added.Verbatim updated from swelling in right knee to swelling in right knee/swollen to size of volleyball.Air on 24-apr-2019 from lawyer.Medical history updated.Additional event of slow cadence was added.Verbatim for pain in right knee was updated to pain in right knee/tenderness anterior knee/arthritic pain right knee.Verbatim for edema right knee updated to edema right knee/ fluctuating knee edema/ edema left knee.Outcome updated.Onset date for the event of septic arthritis of right knee added.Air on 26-apr-2019 from lawyer.Medical history, con meds updated.Air on 17-jan-2020 from lawyer.Medical history of irritable bowel syndrome, overweight, chronic insomnia disorder, essential tremor, anxiety, no caffeine use, no drug use.Family history of alzheimers disease, arthritis, benign essential tumor added.Surgical history of lumpectomy, prostate surgery added.Patients weight updated.Events of co2 high, sensorimotor peripheral neuropathy with symptom of numbness and tingling in his feet, off balance at times.Outcome updated to not recovered for immobilized/walking difficulty.

Event Description

Immobilized/walking difficulty [mobility decreased].Slow cadence [walking difficulty] ([pain upon movement]).Septic arthritis of right knee [arthritis septic] ([staphylococcal infection]).Hearing loss was worse after the antibiotic treatment [hearing loss bilateral] ([condition aggravated]).Polyneuoropathy [neuropathy nos].Acute pulmonary embolus [acute massive pulmonary embolism] ([fibrin d dimer increased], [shortness of breath]).Total bilirubin increased [bilirubin increased].Red blood cell count decreased [red blood cell count decreased].Mean corpuscular volume increased [mean corpuscular volume increased].Mean cell hemoglobin increased [mean cell hemoglobin increased].Neutrophil percentage increased [neutrophil percentage increased].Lymphocyte percentage decreased [lymphocyte percentage decreased].Lymphocyte count decreased [lymphocyte count decreased].Serum potassium decreased [serum potassium decreased].Blood urea nitrogen increased [blood urea nitrogen increased].Urinary tract infection [urinary tract infection].Unable to control bladder [loss of bladder sensation].Co2 high [carbon dioxide high].Sensorimotor peripheral neuropathy [peripheral sensorimotor neuropathy] ([numbness in feet], [tingling sensation]).Off balance at times [balance disorder].Dark urine [urine discoloration].Total protein high [total protein high].Bun (blood urea nitrogen) high [blood urea nitrogen increased].Effusion of left elbow [effusion of elbow].Edema right knee/ fluctuating knee edema/edema left knee [edema knees].Platelet count decreased [platelet count decreased].Chills.Fever.Swelling in both legs.Moderate ecchymasis left knee/ecchymosis left distal hamstring/popliteal fossa [ecchymosis injection site].Pain in right knee/tenderness anterior knee/arthritic pain right knee [aching (r) knee] ([pain upon movement]).Swelling in right knee/swollen to size of volleyball [swelling of r knee].Knee effusion [effusion (r) knee].Stress right knee [stiff knees].Rt knee red [injection site joint redness].Heat [joint warmth].Lipoma back of neck [lipoma] ([local swelling]).Intermittent pain [pain].Abnormal coagulation profile [abnormal coagulation profile].Mixed hyperlipidemia [hyperlipidemia].Case narrative: based on the information received on 11-sep-2018, case became medically confirmed.Upon internal review the case upgraded frm non-valid to valid as new events were add.Initial information received on 09-aug-2018 and 15-aug-2018 ws processed together regarding an unsolicited serious valid legal case frm united states received frm a lawyer.This case involves a 67 years old male patient (183 cm and 94 kg) who experienced immobilized/walking difficulty, slow cadence, septic arthritis of right knee, hearing loss ws worse after the antibiotic treatment, total bilirubin increased (inc), red blood cell count decreased (dec), mean corpuscular volume inc, mean cell hemoglobin inc, neutrophil percentage inc, lymphocyte percentage dec, lymphocyte count dec, platelet count dec, serum potassium dec, blood urea nitrogen inc, acute pulmonary embolus, polyneuoropathy, abnormal coagulation profile, mixed hyperlipidemia, swelling in both legs, urinary tract infection, edema right knee/ fluctuating knee edema/edema left knee, unable to control bladder, fever, chills, dark urine, effusion of left elbow, moderate ecchymasis left knee/ecchymosis left distal hamstring/popliteal fossa, pain in right knee/tenderness anterior knee/arthritic pain right knee, swelling in right knee/swollen to size of volleyball, knee effusion, stress right knee, rt knee red, heat, co2 high, sensorimotor peripheral neuropathy, off balance at times, total protein high, lipoma back of neck and intermittent pain and bun (blood urea nitrogen) high while he ws treated with hylan g-f 20, sodium hyaluronate (synvisc) and vancomycin.Medical history: cardiomyopathy-non ischemic, right sided chf, tricuspid regurgitation mild to moderate, patent foramen ovale, , right eye red, mva (motor vehicle accident), bilateral knee flexion limited, inc cholesterol, depression, stress fractures (possible at third metatarsal), wheelchair user, left foot problem/pain, diffuse edema in foot, gout in his heels, peroneus longus tendon repair due to rupture (sesamoid fracture adjacent to the cuboid), walking aid user (crutches), patellectomy, foot inversion injury on (b)(6)2003, stroke, bladder problems, popping sensation in elbow (once a day when he reaches full extension), memory loss, convulsions, impairment of balance, hearing loss (disability and medically significant), sexual dysfunction, hypersomnolence, irritable bowel syndrome, overweight, chronic insomnia disorder, essential tremor, anxiety, no caffeine use, no drug use, abnormal heart rhythm, spinal stenosis, dec hearing, feet swelling, (b)(6)2003 dexa scan revealed no significant evidence of osteopenia or osteoporosis, cardiac pacemaker insertion on (b)(6)2014, seizure disorder (last episode on (b)(6)2013), hypersensitive heart disease with heart failure on (b)(6)2017, obstructive sleep apnea frm (b)(6)2017 (used positive airway pressure every night), gastrooesophageal reflux disease without esophagitis on (b)(6)2017, migraine, back problems, kidney stone, osteoporosis, head pain, head collision, lower bilateral extremities pain, fell.Copd and arthritis joint, pneumonia, pneumonia (trouble with short and long term memory), tremors, trouble with balance/gait, shuffling feet, intermittent headache, shortness of breath, large hematoma of left arm bicep, change in vision, thoracic spondylosis right groin pain, bilateral renal cysts (including large cyst in right kidney measuring up to 10.7 cm), flu shot in (b)(6)2017.Concurrent conditions: elbow tendonitis in 2018, chronic atrial fibrillation ((b)(6)2014), hypertension, fentanyl allergy, chronic peroneal tendon synovitis, chronic pain to neck, chronic pain to lower back, chronic pain to rt shoulder, varicose veins for which symptoms include mild edema and some leg pain, arthritis, aggravated by prolonged standing, chest pain, chronic fatigue, daytime somnolence, hyperlipidemia, right leg with painful varicose veins, allergy with codeine, allergy to norco, allergy to pravastatin sodium and atorvastatin calcium with side effect of myalgias, sinusitis, drug allergy, vocal cord surgery, cataract removal, dizziness, vestibular neuronitis, congestion for left ear, fever, vertigo, decrease in hearing, abrasion of right ear canal, sensorineural hearing loss, hearing aid, superficial mycosis, nasal congestion, allergic rhinitis, dysphagia, throat pain, swelling, mass or lump in head and neck, acute upper respiratory infections of unspecified site, difficulty talking.Non-tobacco user, abstained frm alcohol.The patient ws a former smoker.Surgical history: lumpectomy, prostate surgery, patellectomy (1975) left ankle surgery ((b)(6)2003), cholecystectomy (gall bladder removed), total knee arthroplasty on (b)(6)2005, patellectomy, appendectomy, rotator cuff repair, knee replacement, orthopedic surgeries, shoulder surgery bilaterally, eye surgery, bil rotator cuff, left foot surgery, cardioversion in (b)(6)2014, heart catheterization on (b)(6)2014, right heart catheterization with on (b)(6)2017, knee surgery on (b)(6)2017 and fiberoptic laryngoscopy.Family history: mother, two sisters and brother: coronary artery disease, mother: heart attack and heart condition, sibling: lung disease, sleep apnea/ snoring, depression, smoking, cancer, father: kidney failure, two sisters and brother: osteopenia, hypertension, heart disease/heart trouble, stroke, copd, alzheimers disease, arthritis, benign essential tumor: sister and son.Concomitant medications: meloxicam; amlodipine besylate; aspirin; zosyn, cyanocobalami; fish oil; xarelto; trazodone hcl; levetiracetam; calcium carbonate with d3; ubidecarenone; zetia; primidone; methocarbamol; spironolactone; valsartan; prilosec, lasix; clonazepam; glycopyrrolate; oxycodone; betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); hydrochlorothiazide, norvasc, keppra, desryl, mobic, testosterone cipionate, potassium chloride, nystatin, fluticasone propionate, glycopyrronium bromide (robinul), ciprofloxacin hydrochloride, vitamin b12, lexapro and bystolic, robaxin 750, co q-10, calcium 600+d3, bisoprolol 10 mg-hydrochlorothiazide 6.25 mg, irbesartan, omeprazole delayed release.On (b)(6)2017, pt received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown (unk) dose once (lot - unk) for arthritis.On an unk date in 2017, pt developed septic arthritis of right knee (arthritis bacterial) (hospitalization, medically significant and intervention required) and ws treated for 6 weeks with vancomycin (dose, form, route, frequency: not provided).After the injection, his right knee ws swollen to the size of a volleyball and rt knee red (latency: unk), heat (latency: unk).Pt had a staph infection of right knee and had knee replacement surgery.On (b)(6)2017 after a latency of 3 days total bilirubin ws 1.9 mg/dl, red blood cell count ws 4.49x10e6/ml, mean corpuscular volume ws 101.2 fl, mean cell hemoglobin ws 35.2 %, neutrophil percentage ws 75.5%, lymphocyte percentage ws 13%, lymphocyte count ws 0.70x10e3/ul, platelet count ws 118x10e3/ul, serum potassium ws 3.4mmol/l and blood urea nitrogen ws 22mg/dl.This evnt ws leading to intervention.On the same day, diagnosed with septic arthritis of right knee (hospitalized), immobilized (mobility dec) (disability), moderate ecchymasis left knee, pain in right knee, swelling in right knee, edema right knee, stress right knee and knee effusion.On (b)(6)2017, blood albumin 3.4 g/dl (low) (l), blood bilirubin 1.9 mg/dl (high) (h), lymphocyte percentage dec 13 % (l), blood potassium 3.2 mmol/l (l), carbon dioxide inc 32 mg/dl [high], neutrophil percentage inc 75.5 % (h), platelet count dec 126 10e3/ml (l), mean cell volume 99.5 fl (h), red blood cell count dec 4.45 10e6/ml (l); on (b)(6)2017, blood glucose 134 mg/dl (h), carbon dioxide inc 32 mg/dl (h); mean cell haemoglobin 34.6 pg [high].On (b)(6)2017, follow up for chronic pain to neck, lower back, rt shoulder and rated it 5/10.Pain aggravated upon bending, lifting, prolong sitting and standing.Constant aching radiating lower back pain, more on the right and extended till his feet.On (b)(6)2017, blood urea 24 mg/dl, mean cell haemoglobin 34.6 pg (h), platelet count dec ws 146 10e3/ml (l); red blood cell count dec 4.6 10e6/ml (l), white blood cell count dec 4.6 10e3/ml (l).On (b)(6)2017, blood urea ws 23 mg/dl (h); carbon dioxide ws 33 mg/dl (h), creatinine urine ws 1.24 mg/dl (h), glomerular filtration rate 58 ml/min (l); hematocrit ws 41.8 % (l).A surgery ws performed to correct septic arthritis.Used rolling walker for ambulation, brace.On (b)(6)2018, unable to control bladder (3 months 27 days).On (b)(6)2018, fever (4 months) of 102 at night.On (b)(6)2018, after 4 months 1 day, complaints of chills, dark urine.Urine analysis confirmed urinary tract infection.Pt advised to increase intake of oral fluids.On (b)(6)2018, follow up of his chronic pain to neck, lower back, rt shoulder, rate it 6 on a scale of 10.Pain continued to hurt daily.On (b)(6)2018, issues with swelling of both legs and effusion of right elbow (onset and latency: unk).Same day, ecg showed v paced rhythm.On (b)(6)2018, pt reported for follow up of his chronic pain and stated that his pain radiating, constant.On (b)(6)2018, glucose 114 mg/dl (70-100) (h), bun (blood urea nitrogen) 24 mg/dl (7-21) (h), co2 34 mmol/l (h), total protein 6.2 g/dl (6.4-8.3) (l).On (b)(6)2018, after 9 months 12 days latency, d-dimer assay 0.61 ug/ml (0-0.42) (h).On (b)(6)2018, elevated d-dimer, shortness of breath, nuclear medicine ventilation/perfusion lung scan showed low probability of acute pulmonary embolus.Same day, cxr showed no acute abnormality, vq scan show low probability for acute pulmonary embolus.On (b)(6)2018, used a cane for walking assistance, pain intermittent sharp, radiating into his posterior left lower extremity, extending occasionally to his knee and foot.On (b)(6)2018, ws still using a cane for walking assistance, pain ws now shifting to his right leg, had effusion in and around his right knee.On (b)(6)2019, evaluation of hearing loss.The hearing loss ws worse after the antibiotic treatment (onset date: unk).Post vancomycin audiogram had worsened.Wore bilateral hearing aids.Same day, speech audiometry results were right (ad): 55 dbhl and left ad: 50 dbhl compared to the audiogram of (b)(6)2016 (right ear: 68% and left ear at 76% at 80 db).On (b)(6)2018, lifted his leg and felt pop with inc pain, diagnosed with slow cadence (disability), ambulating with assistance, tenderness in anterior knee and fluctuating knee edema.On (b)(6)2018, tolerated pain well.On (b)(6)2018, pts balance strength inc.On (b)(6)2018, minimal edema observed in the right knee.On an unk date in 2018 after unk latency, patient experienced having polyneuropathy, shortness of breath, abnormal coagulation profile, elevated d-dimer and mixed hyperlipidemia.On (b)(6)2018 perfusion study performed showed probability of acute pulmonay embolism.On (b)(6)2018, inc quadricep exercise and had 0/10 knee pain.On (b)(6)2018, 5/10 right knee pain after doing wall slides.On (b)(6)2018, significant edema in the left knee localized to joint capsule.On (b)(6)2018, severe ecchymosis left distal hamstring/popiteal fossa.On (b)(6)2018, increase quadriceps and balance exercises.On (b)(6)2018, doing well.On (b)(6)2018, balance improved with gait.On (b)(6)2018, had good effort with exercises.On 14-nov-2018, balance ws improved with gait.On (b)(6)2018, 4/10 bilateral knee pain ambulating while extended distance.On (b)(6)2018, his balance with gait ws improved, quadricep exercises were inc.On (b)(6)2018, dec in right knee edema.On (b)(6)2019, doing well.On (b)(6)2019, right knee pain with standing.On (b)(6)2019, he had first arthritic pain right knee, frustrated by continuous pain.On (b)(6)2019, 98.7% ventricular pacing ws observed.On (b)(6)2019, ecg showed left ventricle (lv) wall thickness mildly inc, lv ejection fraction 58%, left to right shunting with qp/qs 0.814, right ventricular dysfunction, left atrium severely dilated, left atrial volume severely dilated, mild to moderate tricuspid regurgitation, no significant changes since last study.On (b)(6)2019, good efforts with quadriceps exercise, knee pain in last 2-3 days.On (b)(6)2019, follow up for chronic atrial fibrillation, had obstructive apnea which ws a contributory factor.No pericardial effusion.On (b)(6)2019, inc resistance with quadriceps strengthening.On (b)(6)2019, complain of obstructive apnea which he had for years.Excessive daytime sleepiness described as moderate, insomnia which ws well controlled, told to use a new mask or machine.On (b)(6)2019, quadricep balance ws inc, good tolerance.On (b)(6)2019, fluid gait with quadriceps, fluctuating pain with gait.On (b)(6)2019, strength and balance improved.On (b)(6)2019, pain ws 3/10.On (b)(6)2019, review of several symptoms including headache.No significant problem, very pleased with his improved control.Lab results: co2 ws 34 mmol/l (21-31) (high), same day, underwent neurodiagnostic study which ws abnormal, the nerve conduction of lower extremities, selective emg ws consistent with sensorimotor peripheral neuropathy (latency:1 year 8 months 7 days).Pts tremors had improved, his memory loss ws fairly stable, not had any seizures since past visit, used a cane, had no recent falls but he did feel off balance at times (latency: 1 year 8 months 7 days).Pt struggling with numbness and tingling in his feet, he stated that he had some burning discomfort at times and symptoms were worse at night.Lost 5 pounds, working towards losing weight.Continued keppra for tremors and ws told to get tests done for his neuropathy.On (b)(6)2019, patient visited doctor with c/o neck lipoma and had intermittent pain for several months.The assessment revealed localized swelling, mass, lump, trunk with supple neck and bony prominence which was believed to be t1 spinous process and not lipoma.On (b)(6)2020, headache had improved, his seizures continued to be problematic, but he had managed his tremors.Pts tremors caused him problems with pouring his coffee, he used primidone for it.Used a cane and felt off balance at times.Lab results were good except b12, which ws low, taking supplements.Quality of life measures and excessive daytime sleepiness assessed using epworth sleepiness scale.Counseling and lifestyle education regarding diet and exercises, follow up in 6 months.On (b)(6)2020, pt underwent the implanted pacemaker review which showed 5 episodes of ventricular high rate.Action taken: unk for vancomycin fr all ev; not applicable for hylan g-f 20, sodium hyaluronate fr all ev corrective: vancomycin for arthritis bacterial; ceftriaxone, total knee replacement for arthritis bacterial and staph infection of right knee; rolling walker for immobilized; walking difficulty; rocephin, cipro, pyridium for urinary tract infection; not reported for rest outcome: not recovered for off balance at times, immobilized/walking difficulty, co2 high, hearing loss ws worse after the antibiotic treatment, total bilirubin inc, red blood cell count dec, mean corpuscular volume inc, mean cell hemoglobin inc, neutrophil percentage inc, lymphocyte percentage dec, lymphocyte count dec, platelet count dec, serum potassium dec and blood urea nitrogen inc; pain in right knee/tenderness anterior knee/arthritic pain right knee; recovering for slow cadence, edema right knee/ fluctuating knee edema/edema left knee; unk for rest of the evnts a product technical complaint (ptc) ws initiated on 22-aug-2018 for synvisc.Batch number unk, global ptc number: (b)(4).The product lot number ws not provided; therefore, a batch record review ws not possible.Based on the lack of information provided, no capa ws required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse evnt reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date ws 22-aug-2018.Additional information ws received (air) on 22-aug-2018.Ptc results and number were add.Air on 11-sep-2018 healthcare professional (hcp).Evnts total bilirubin inc, red blood cell count dec, mean corpuscular volume inc, mean cell hemoglobin inc, neutrophil percentage inc, lymphocyte percentage dec, lymphocyte count dec, platelet count dec, serum potassium dec, and blood urea nitrogen inc add.Medical history, con meds add.Air on 06-dec-2018 lawyer.Medical history, con meds updated.Evnts swelling in both legs, effusion of left elbow, elevated d-dimer add.Air 13-dec-2018.No new information (nni).Air 11-jan-2019 the lawyer.Con meds updated.Air on 14-jan-2019 and 16-jan-2019 (csd 14-jan-2019) frm lawyer.Medical history updated.Staph infection of right knee add, adverse evnt nos deleted.Air on 24-jan-2019 and 25-jan-2019 frm lawyer.Nni.Air on 30-jan-2019 lawyer.Medical history updated.Air on 11-feb-2019 lawyer.Medical history, surgical history, con meds add.Evnts of fever, chills, dark urine, unable to control bladder, urinary tract infection.Air on 19-feb-2019 hcp.Suspect vancomycin add.Evnt of hearing loss worsened after antibiotics add.Air on 05-mar-2019 hcp.Medical, family, surgical history add.Evnt of rt knee red, heat add.Verbatim updated frm swelling in right knee to swelling in right knee/swollen to size of volleyball.Air on 24-apr-2019 lawyer.Medical history.Slow cadence add.Verbatim for pain in right knee ws updated to pain in right knee/tenderness anterior knee/arthritic pain right knee.Verbatim for edema right knee updated to edema right knee/ fluctuating knee edema/ edema left knee.Outcome updated.Onset date for the evnt of septic arthritis of right knee add.Air on 26-apr-2019 lawyer.Medical history, con meds updated.Air 17jan20 lawyer.Medical history of irritable bowel syndrome, overweight, chronic insomnia disorder, essential tremor, anxiety, no caffeine use, no drug use.Family history of alzheimers disease, arthritis, benign essential tumor add.Surgical history of lumpectomy, prostate surgery add.Patients weight updated.Evnts of co2 high, sensorimotor peripheral neuropathy with symptom of numbness and tingling in his feet, off balance at times.Outcome updated to not recovered for immobilized/walking difficulty.Air 22jan20 lawyer.Lab test results of ecg add.Medical history added.Details pertaining to patients history of chronic atrial fibrillation add.Evnts of total protein high and bun (blood urea nitrogen) high add.Evnt onset date updated for elevated d-dimer.Air 28jan20 lawyer.Evnt add lipoma, intermittent pain.Concomitant medications add.Air 13feb20 hcp.Ev added.

Event Description

Immobilized/walking difficulty [mobility decreased].Hearing loss was worse after the antibiotic treatment [hearing loss bilateral] ([condition aggravated]).Polyneuropathy [neuropathy nos].Acute pulmonary embolus [acute massive pulmonary embolism] ([fibrin d dimer increased], [shortness of breath]).Septic arthritis of right knee [arthritis septic] ([staphylococcal infection]).Slow cadence [walking difficulty] ([pain upon movement]).Total bilirubin increased [bilirubin increased].Red blood cell count decreased [red blood cell count decreased].Mean corpuscular volume increased [mean corpuscular volume increased].Mean cell hemoglobin increased [mean cell hemoglobin increased].Neutrophil percentage increased [neutrophil percentage increased].Lymphocyte percentage decreased [lymphocyte percentage decreased].Lymphocyte count decreased [lymphocyte count decreased].Serum potassium decreased [serum potassium decreased].Blood urea nitrogen increased [blood urea nitrogen increased].Urinary tract infection [urinary tract infection].Unable to control bladder [loss of bladder sensation].Co2 high [carbon dioxide high].Sensorimotor peripheral neuropathy [peripheral sensorimotor neuropathy] ([numbness in feet], [tingling sensation]).Off balance at times [balance disorder].Dark urine [urine discoloration].Total protein high [total protein high].Bun (blood urea nitrogen) high [blood urea nitrogen increased].Intermittent pain [pain].Lipoma back of neck [lipoma] ([local swelling]).Abnormal coagulation profile [abnormal coagulation profile].Mixed hyperlipidemia [hyperlipidemia].Effusion of left elbow [effusion of elbow].Edema right knee/ fluctuating knee edema/edema left knee [edema knees].Platelet count decreased [platelet count decreased].Chills [chills].Fever [fever].Swelling in both legs [swelling of legs].Moderate ecchymasis left knee/ecchymosis left distal hamstring/popliteal fossa [ecchymosis injection site].Rt knee red [injection site joint redness].Knee effusion [effusion (r) knee].Swelling in right knee/swollen to size of volleyball [swelling of r knee].Stress right knee [stiff knees].Heat [joint warmth].Pain in right knee/tenderness anterior knee/arthritic pain right knee [aching (r) knee].([pain upon movement]).Case narrative: based on the information received on 11sep2018, case became medically confirmed.Upon internal review the case upgraded frm non-valid to valid as new events were add.Initial information received on 09aug2018 and 15aug2018 was processed together regarding an unsolicited serious valid legal case fr0m united states received from a lawyer.This case involves a 67 years old male patient (183 cm and 94 kg) who experienced immobilized/walking difficulty, slow cadence, septic arthritis of right knee, hearing loss ws worse after the antibiotic treatment, total bilirubin increased (inc), red blood cell count decreased (dec), mean corpuscular volume inc, mean cell hemoglobin inc, neutrophil percentage inc, lymphocyte percentage dec, lymphocyte count dec, platelet count dec, serum potassium dec, blood urea nitrogen inc, acute pulmonary embolus, polyneuropathy, abnormal coagulation profile, mixed hyperlipidemia, swelling in both legs, urinary tract infection, edema right knee/ fluctuating knee edema/edema left knee, unable to control bladder, fever, chills, dark urine, effusion of left elbow, moderate ecchymasis left knee/ecchymosis left distal hamstring/popliteal fossa, pain in right knee/tenderness anterior knee/arthritic pain right knee, swelling in right knee/swollen to size of volleyball, knee effusion, stress right knee, rt knee red, heat, co2 high, sensorimotor peripheral neuropathy, off balance at times, total protein high, lipoma back of neck and intermittent pain and bun (blood urea nitrogen) high while he ws treated with hylan g-f 20, sodium hyaluronate (synvisc) and vancomycin.Medical history: severe heart burn, hiatal hernia, kidney infection, pain vocal cord, sinus discharge, right sided chf, tricuspid regurgitation mild to moderate, patent foramen ovale, right eye red, mva (motor vehicle accident), bilateral knee flexion limited, inc cholesterol, depression, stress fractures (possible at third metatarsal), wheelchair user, left foot problem/pain, diffuse edema in foot, gout in his heels, peroneus longus tendon repair due to rupture (sesamoid fracture adjacent to the cuboid), walking aid user (crutches), patellectomy, foot inversion injury on (b)(6) 2003, stroke, bladder problems, popping sensation in elbow (once a day when he reaches full extension), memory loss, convulsions, impairment of balance, hearing loss, sexual dysfunction, hypersomnolence, irritable bowel syndrome, overweight, chronic insomnia disorder, essential tremor, anxiety, no caffeine use, no drug use, abnormal heart rhythm, spinal stenosis, dec hearing and used hearing aids, feet swelling, (b)(6) 2003, dexa scan revealed no significant evidence of osteopenia or osteoporosis, on (b)(6) 2008, audiogram: dec in hearing threshold levels with inc frequency after approx 1500 hz in both ears (had over the ear aids), on (b)(6) 2012, otalgia unspecified/right otalgia, (b)(6) 2013 cough (onset: (b)(6) 2013), audiogram: overall dec in hearing threshold levels with inc frequency in both ears.Otoscopic observation clear in both ears and on (b)(6) 2014: dec in hearing threshold levels with inc frequency in both ears, cardiomyopathy-non ischemic, sudden onset of throat pain on (b)(6) 2013, cardiac pacemaker insertion on (b)(6) 2014, seizure disorder (last episode on (b)(6) 2013), hypersensitive heart disease with heart failure on (b)(6) 2017, obstructive sleep apnea frm (b)(6) 2017 (used positive airway pressure every night), gastrooesophageal reflux disease without esophagitis on (b)(6) 2017, migraine, back problems, kidney stone, osteoporosis, head pain, head collision, lower bilateral extremities pain, fell.Copd and arthritis joint, pneumonia requiring hospitalization (trouble with short and long term memory), tremors, trouble with balance/gait, shuffling feet, intermittent headache (severe), shortness of breath, large hematoma of left arm bicep, change in vision, thoracic spondylosis right groin pain, bilateral renal cysts (including large cyst in right kidney measuring up to 10.7 cm), flu shot in (b)(6) 2017.Concurrent conditions: unspecified essential hypertension (high blood pressure), elbow tendonitis in 2018, chronic atrial fibrillation (b)(6) 2014, chronic peroneal tendon synovitis, chronic pain to neck, chronic pain to lower back, chronic pain to rt shoulder, varicose veins for which symptoms include mild edema and some leg pain, arthritis, aggravated by prolonged standing, chest pain, chronic fatigue, daytime somnolence, hyperlipidemia, right leg with painful varicose veins, allergy with codeine phosphate: vomiting, norco, fentanyl, pravastatin sodium and atorvastatin calcium with side effect of myalgias, sinusitis, , vocal cord surgery, cataract removal, dizziness, vestibular neuronitis, congestion for left ear, fever, vertigo, abrasion of right ear canal, sensorineural hearing loss, superficial mycosis, nasal congestion, allergic rhinitis, dysphagia, throat pain, swelling, mass or lump in head and neck, acute upper respiratory infections of unspecified site, difficulty talking.Non-tobacco user, abstained frm alcohol.The patient ws a former smoker.Surgical history: lumpectomy, prostate surgery, patellectomy (1975) left ankle surgery (b)(6) 2003, cholecystectomy (gall bladder removed), total knee arthroplasty on (b)(6) 2005, patellectomy, appendectomy, rotator cuff repair, knee replacement, orthopedic surgeries, shoulder surgery bilaterally, eye surgery, bil rotator cuff, left foot surgery, cardioversion in (b)(6) 2014, heart catheterization on (b)(6) 2014, right heart catheterization with on (b)(6) 2017, knee surgery on (b)(6) 2017 and fiberoptic laryngoscopy.Family history: high blood pressure, cancer, mother, two sisters and brother: coronary artery disease, mother: heart attack and heart condition, sibling: lung disease, sleep apnea/ snoring, depression, smoking, cancer, father: kidney failure, two sisters and brother: osteopenia, hypertension, heart disease/heart trouble, stroke, copd, alzheimers disease, arthritis, benign essential tumor: sister and son.Concomitant medications (conmeds): meloxicam; amlodipine besylate; aspirin; zosyn; fish oil; xarelto; trazodone hcl; levetiracetam; calcium carbonate with d3; ubidecarenone; zetia; primidone; methocarbamol; spironolactone; valsartan; prilosec, lasix; clonazepam; glycopyrrolate; oxycodone; betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, cholecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); hydrochlorothiazide, norvasc, keppra, desryl, mobic, testosterone cipionate, potassium chloride, nystatin, fluticasone propionate, glycopyrronium bromide (robinul), ciprofloxacin hydrochloride, vitamin b12, lexapro and bystolic, robaxin 750, co q-10, bisoprolol, g-hydrochlorothiazide, irbesartan, omeprazole delayed release, promethazine, clarithromycin (biaxin), temazepam (restoril), carvedilol (coreg), carvedilol, clonidine.On (b)(6) 2017, pt received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown (unk) dose once (lot - unk) for arthritis.On an unk date in 2017, pt developed septic arthritis of right knee (arthritis bacterial) (hospitalization, medically significant and intervention required) and ws treated for 6 weeks with vancomycin (dose, form, route, frequency: not provided).After the injection, his right knee ws swollen to the size of a volleyball and rt knee red (latency: unk), heat (latency: unk).Pt had a staph infection of right knee and had knee replacement surgery.On (b)(6) 2017 after a latency of 3 days total bilirubin ws 1.9 mg/dl, red blood cell count ws 4.49x10e6/ml, mean corpuscular volume ws 101.2 fl, mean cell hemoglobin ws 35.2 %, neutrophil percentage ws 75.5%, lymphocyte percentage ws 13%, lymphocyte count ws 0.70x10e3/ul, platelet count ws 118x10e3/ul, serum potassium ws 3.4mmol/l and blood urea nitrogen ws 22mg/dl.This event ws leading to intervention.On the same day, diagnosed with septic arthritis of right knee (hospitalized), immobilized (mobility dec) (disability), moderate ecchymasis left knee, pain in right knee, swelling in right knee, edema right knee, stress right knee and knee effusion.On (b)(6) 2017, blood albumin 3.4 g/dl (low) (l), blood bilirubin 1.9 mg/dl (high) (h), lymphocyte percentage dec 13 % (l), blood potassium 3.2 mmol/l (l), carbon dioxide inc 32 mg/dl [high], neutrophil percentage inc 75.5 % (h), platelet count dec 126 10e3/ml (l), mean cell volume 99.5 fl (h), red blood cell count dec 4.45 10e6/ml (l); on (b)(6) 2017, blood glucose 134 mg/dl (h), carbon dioxide inc 32 mg/dl (h); mean cell haemoglobin 34.6 pg [high].On (b)(6) 2017, follow up for chronic pain to neck, lower back, rt shoulder and rated it 5/10.Pain aggravated upon bending, lifting, prolong sitting and standing.Constant aching radiating lower back pain, more on the right and extended till his feet.On (b)(6) 2017, blood urea 24 mg/dl, mean cell haemoglobin 34.6 pg (h), platelet count dec ws 146 10e3/ml (l); red blood cell count dec 4.6 10e6/ml (l), white blood cell count dec 4.6 10e3/ml (l).On (b)(6) 2017, blood urea ws 23 mg/dl (h); carbon dioxide ws 33 mg/dl (h), creatinine urine ws 1.24 mg/dl (h), glomerular filtration rate 58 ml/min (l); hematocrit ws 41.8 % (l).A surgery ws performed to correct septic arthritis.Used rolling walker for ambulation, brace.On (b)(6) 2018, unable to control bladder (3 months 27 days).On (b)(6) 2018, fever (4 months) of 102 at night.On (b)(6) 2018, after 4 months 1 day, complaints of chills, dark urine.Urine analysis confirmed urinary tract infection.Pt advised to increase intake of oral fluids.On (b)(6) 2018, follow up of his chronic pain to neck, lower back, rt shoulder, rate it 6 on a scale of 10.Pain continued to hurt daily.On (b)(6) 2018, issues with swelling of both legs and effusion of right elbow (onset and latency: unk).Same day, ecg showed v paced rhythm.On (b)(6) 2018, pt reported for follow up of his chronic pain and stated that his pain radiating, constant.On (b)(6) 2018, glucose 114 mg/dl (70-100) (h), bun (blood urea nitrogen) 24 mg/dl (7-21) (h), co2 34 mmol/l (h), total protein 6.2 g/dl (6.4-8.3) (l).On (b)(6) 2018, after 9 months 12 days latency, d-dimer assay 0.61 ug/ml (0-0.42) (h).On (b)(6) 2018, elevated d-dimer, shortness of breath, nuclear medicine ventilation/perfusion lung scan showed low probability of acute pulmonary embolus.Same day, cxr showed no acute abnormality, vq scan show low probability for acute pulmonary embolus.On (b)(6) 2018, used a cane for walking assistance, pain intermittent sharp, radiating into his posterior left lower extremity, extending occasionally to his knee and foot.On (b)(6) 2018, ws still using a cane for walking assistance, pain ws now shifting to his right leg, had effusion in and around his right knee.On (b)(6) 2019, evaluation of hearing loss.The hearing loss ws worse after the antibiotic treatment (onset date: unk) (disability and medically significant).Post vancomycin audiogram had worsened.Wore bilateral hearing aids.Same day, speech audiometry results were right (ad): 55 dbhl and left ad: 50 dbhl compared to the audiogram of (b)(6) 2016 (right ear: 68% and left ear at 76% at 80 db).On (b)(6) 2018, lifted his leg and felt pop with inc pain, diagnosed with slow cadence (disability), ambulating with assistance, tenderness in anterior knee and fluctuating knee edema.On (b)(6) 2018, tolerated pain well.On (b)(6) 2018, pts balance strength inc.On (b)(6) 2018, minimal edema observed in the right knee.On an unk date in 2018 after unk latency, patient experienced having polyneuropathy, shortness of breath, abnormal coagulation profile, elevated d-dimer and mixed hyperlipidemia.On (b)(6) 2018 perfusion study performed showed probability of acute pulmonary embolism.On (b)(6) 2018, inc quadricep exercise and had 0/10 knee pain.On (b)(6) 2018, 5/10 right knee pain after doing wall slides.On (b)(6) 2018, significant edema in the left knee localized to joint capsule.On (b)(6) 2018, severe ecchymosis left distal hamstring/popliteal fossa.On (b)(6) 2018, increase quadriceps and balance exercises.On (b)(6) 2018, doing well.On (b)(6) 2018, balance improved with gait.On (b)(6) 2018, had good effort with exercises.On (b)(6) 2018, balance ws improved with gait.On (b)(6) 2018, 4/10 bilateral knee pain ambulating while extended distance.On (b)(6) 2018, his balance with gait ws improved, quadricep exercises were inc.On (b)(6) 2018, dec in right knee edema.On (b)(6) 2019, doing well.On (b)(6) 2019, right knee pain with standing.On (b)(6) 2019, he had first arthritic pain right knee, frustrated by continuous pain.On (b)(6) 2019, 98.7% ventricular pacing ws observed.On (b)(6) 2019, ecg showed left ventricle (lv) wall thickness mildly inc, lv ejection fraction 58%, left to right shunting with qp/qs 0.814, right ventricular dysfunction, left atrium severely dilated, left atrial volume severely dilated, mild to moderate tricuspid regurgitation, no significant changes since last study.On (b)(6) 2019, good efforts with quadriceps exercise, knee pain in last 2-3 days.On (b)(6) 2019, follow up for chronic atrial fibrillation, had obstructive apnea which ws a contributory factor.No pericardial effusion.On (b)(6) 2019, inc resistance with quadriceps strengthening.On (b)(6) 2019, complain of obstructive apnea which he had for years.Excessive daytime sleepiness described as moderate, insomnia which ws well controlled, told to use a new mask or machine.On (b)(6) 2019, quadricep balance ws inc, good tolerance.On (b)(6) 2019, fluid gait with quadriceps, fluctuating pain with gait.On (b)(6) 2019, strength and balance improved.On (b)(6) 2019, pain ws 3/10.On (b)(6) 2019, review of several symptoms including headache.No significant problem, very pleased with his improved control.Lab results: co2 ws 34 mmol/l (21-31) (high), same day, underwent neurodiagnostic study which ws abnormal, the nerve conduction of lower extremities, selective emg ws consistent with sensorimotor peripheral neuropathy (latency:1 year 8 months 7 days).Pts tremors had improved, his memory loss ws fairly stable, not had any seizures since past visit, used a cane, had no recent falls but he did feel off balance at times (latency: 1 year 8 months 7 days).Pt struggling with numbness and tingling in his feet, he stated that he had some burning discomfort at times and symptoms were worse at night.Lost 5 pounds, working towards losing weight.Continued keppra for tremors and ws told to get tests done for his neuropathy.On (b)(6) 2019, patient visited doctor with c/o neck lipoma and had intermittent pain for several months.The assessment revealed localized swelling, mass, lump, trunk with supple neck and bony prominence which was believed to be t1 spinous process and not lipoma.On (b)(6) 2020, headache had improved, his seizures continued to be problematic, but he had managed his tremors.Pts tremors caused him problems with pouring his coffee, he used primidone for it.Used a cane and felt off balance at times.Lab results were good except b12, which ws low, taking supplements.Quality of life measures and excessive daytime sleepiness assessed using epworth sleepiness scale.Counseling and lifestyle education regarding diet and exercises, follow up in 6 months.On (b)(6) 2020, pt underwent the implanted pacemaker review which showed 5 episodes of ventricular high rate.Action taken: unk for vancomycin fr all ev; not applicable for hylan g-f 20, sodium hyaluronate fr all ev.Corrective: vancomycin for arthritis bacterial; ceftriaxone, total knee replacement for arthritis bacterial and staph infection of right knee; rolling walker for immobilized; walking difficulty; rocephin, cipro, pyridium for urinary tract infection; not reported for rest.Outcome: not recovered for off balance at times, immobilized/walking difficulty, co2 high, hearing loss ws worse after the antibiotic treatment, total bilirubin inc, red blood cell count dec, mean corpuscular volume inc, mean cell hemoglobin inc, neutrophil percentage inc, lymphocyte percentage dec, lymphocyte count dec, platelet count dec, serum potassium dec and blood urea nitrogen inc; pain in right knee/tenderness anterior knee/arthritic pain right knee; recovering for slow cadence, edema right knee/ fluctuating knee edema/edema left knee; unk for rest.A product technical complaint (ptc) ws initiated on 22aug2018 for synvisc.Batch number unk, global ptc number: (b)(4).The product lot number ws not provided; therefore, a batch record review ws not possible.Based on the lack of information provided, no capa ws required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by (b)(4) and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Investigation complete date: 22aug2018.Additional information ws received (air) on 22aug2018.Ptc results and number added.Air on 11sep2018 healthcare professional (hcp).Events total bilirubin inc, red blood cell count dec, mean corpuscular volume inc, mean cell hemoglobin inc, neutrophil percentage inc, lymphocyte percentage dec, lymphocyte count dec, platelet count dec, serum potassium dec, and blood urea nitrogen inc add.Medical history, con meds add.Air on 06dec2018 lawyer.Medical history, con meds updated.Events swelling in both legs, effusion of left elbow, elevated d-dimer add.Air 13dec2018.No new information (nni).Air 11jan2019 the lawyer.Con meds updated.Air on 14jan2019 and 16jan2019 (csd 14jan2019) frm lawyer.Medical history updated.Staph infection of right knee add, adverse event nos deleted.Air on 24jan2019 and 25jan2019 frm lawyer.Nni.Air on 30jan2019 lawyer.Medical history updated.Air on 11feb2019 lawyer.Medical history, surgical history, con meds add.Events of fever, chills, dark urine, unable to control bladder, urinary tract infection.Air on 19feb2019 hcp.Suspect vancomycin add.Event of hearing loss worsened after antibiotics add.Air 05mar2019 hcp.Medical, family, surgical history add.Event of rt knee red, heat add.Verbatim updated frm swelling in right knee to swelling in right knee/swollen to size of volleyball.Air 24apr2019 lawyer.Medical history.Slow cadence add.Verbatim and outcome updated.Onset date for the event of septic arthritis of right knee add.Air 26apr2019 lawyer.Medical history, conmeds updated.Air 17jan20 lawyer.Medical history and family history added.Patients weight updated.Events of co2 high, sensorimotor peripheral neuropathy with symptom of numbness and tingling in his feet, off balance at times.Outcome updated.Air 22jan20 lawyer.Lab test results of ecg add.Medical history added.Details pertaining to patients history of chronic atrial fibrillation add.Events of total protein high and bun (blood urea nitrogen) high add.Event onset date updated for elevated d-dimer.Air 28jan20 lawyer.Event add lipoma, intermittent pain.Conmeds add.Air 13feb20 hcp.Ev added.Air 21feb2020 lawyer: medical history and conmeds updated.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 7915532
• MDR Text Key: 121925685
• Report Number: 2246315-2018-00577
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMLODIPINE BESYLATE (AMLODIPINE BESYLATE),UNKNOWN; ASPIRIN [ACETYLSALICYLIC ACID],UNKNOWN; BISOPROLOL FUMARATE (BISOPROLOL FUMARATE),UNKNOWN; CALCIUM CARBONATE WITH D3,UNKNOWN; CLONAZEPAM (CLONAZEPAM),UNKNOWN; CYANOCOBALAMIN (CYANOCOBALAMIN),UNKNOWN; EZETIMIBE (EZETIMIBE),UNKNOWN; FUROSEMIDE (FUROSEMIDE),UNKNOWN; GLYCOPYRROLATE [GLYCOPYRRONIUM BROMIDE],UNKNOWN; HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE),UNKNOWN; LEVETIRACETAM (LEVETIRACETAM),UNKNOWN; MELOXICAM (MELOXICAM),UNKNOWN; METHOCARBAMOL (METHOCARBAMOL),UNKNOWN; MULTIVITAMIN & MINERAL,UNKNOWN; OMEGA 3 FISH OILS (FISH OIL),UNKNOWN; ONDANSETRON (ONDANSETRON),; OXYCODONE (OXYCODONE),UNKNOWN; PRILOSEC [OMEPRAZOLE] (OMEPRAZOLE),CAPSULE; PRIMIDONE (PRIMIDONE),UNKNOWN; RIVAROXABAN (RIVAROXABAN),UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),UNKNOWN; TRAZODONE HCL (TRAZODONE HCL),UNKNOWN; UBIDECARENONE (UBIDECARENONE),UNKNOWN; VALSARTAN (VALSARTAN),UNKNOWN; ZOSYN (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM),; AMLODIPINE BESYLATE (AMLODIPINE BESYLATE),UNKNOWN; ASPIRIN [ACETYLSALICYLIC ACID],UNKNOWN; BISOPROLOL FUMARATE (BISOPROLOL FUMARATE),UNKNOWN; CALCIUM CARBONATE WITH D3,UNKNOWN; CLONAZEPAM (CLONAZEPAM),UNKNOWN; CYANOCOBALAMIN (CYANOCOBALAMIN),UNKNOWN; EZETIMIBE (EZETIMIBE),UNKNOWN; FUROSEMIDE (FUROSEMIDE),UNKNOWN; GLYCOPYRROLATE [GLYCOPYRRONIUM BROMIDE],UNKNOWN; HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE),UNKNOWN; LEVETIRACETAM (LEVETIRACETAM),UNKNOWN; MELOXICAM (MELOXICAM),UNKNOWN; METHOCARBAMOL (METHOCARBAMOL),UNKNOWN; MULTIVITAMIN & MINERAL,UNKNOWN; OMEGA 3 FISH OILS (FISH OIL),UNKNOWN; ONDANSETRON (ONDANSETRON),; OXYCODONE (OXYCODONE),UNKNOWN; PRILOSEC [OMEPRAZOLE] (OMEPRAZOLE),CAPSULE; PRIMIDONE (PRIMIDONE),UNKNOWN; RIVAROXABAN (RIVAROXABAN),UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),UNKNOWN; TRAZODONE HCL (TRAZODONE HCL),UNKNOWN; UBIDECARENONE (UBIDECARENONE),UNKNOWN; VALSARTAN (VALSARTAN),UNKNOWN; ZOSYN (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM),
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 67 YR
• Patient Weight: 94