|
This unsolicited case from united states was received on 08-jan-2018 from patient.This case concerns (b)(6) year old female patient who received treatment with synvisc one and later after few hours of receiving injection patient had infection, could not walk and could not put pressure on knee.Also, device malfunction was identified for the reported lot number.No concomitant medication or concurrent condition was provided.Patient denied allergy to eggs but states that she has asthma and is allergic to feathers, plants and ragweed.Caller has asthma and panic attacks.On an unknown date in (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, at a dose of 6 ml once (batch/lot number: 7rsl021, expiry date: not reported) for osteoarthritis in left knee.This was patient first time receiving the synvisc- one injection.On an unknown date in (b)(6) 2017, after few hours of receiving injection, it was stated that day after the synvisc-one injection, patient knee started "acting up" with swelling and she could not put any pressure on it.Pain score of 10.It was stated that by the 2nd or 3rd day, patient could not walk and called the ambulance to get her out of bed.Patient was taken to the hospital and admitted for three days where she received antibiotics, fluids and pain medication.Patient did not do any exercise post injection, had a walker to use for ambulation and was unsure if she had a fever.Patient stated at the hospital they took blood work, drained the knee and performed cultures which showed infection.Patient stated that the swelling has gone down quite a bit, but she still had a pain score of 7 with weight bearing activities.Patient stated that her knee was worse than before she took the synvisc- one.Patient taken naproxen and was supposed to go back to the hcp (health care professional) on (b)(6) 2018.Patient does not have prosthetic, defibrillator, pacemaker.Patient stated that disinfectant was used prior to synvisc-one injection corrective treatment: antibiotics, fluids and pain med cation (naproxen) for infection; walker for ambulation for could i not walk; not reported for rest events outcome: not recovered for could not walk; recovering for rest events an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation was completed, corrective and preventive actions would be implemented.Seriousness criterion: hospitalization for all events pharmacovigilance comment: sanofi company comment dated 11-jan-2018: this case concerns a female patient who had received synvisc-one injection from re-called lot and later developed joint infection, swelling, pain, had walking and weight bearing difficulties and had knee effusion.The temporal relationship is significant and hence, causal role of suspect product cannot be ruled out in occurrence of the event.Furthermore, the concerned lot has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
|
|
Device malfunction.Infection/ infective arthritis [arthritis infective] ([swelling of l knee], [knee pain], [effusion (l) knee], [joint inflammation], [injection site erythema], [joint warmth]).Could not walk.Could not put pressure on knee/unable to bear a lot of weight [weight bearing difficulty].Pseudosepsis arthritis.Pneumonia.Activities of daily living impaired.Pain with range of motion [joint range of motion decreased].Synovial fluid appearance turbid [synovial fluid analysis abnormal].Synovial fluid wbc 79000 [synovial fluid white blood cells positive].Knee stiffness.Case narrative: based on additional information received on 30-oct-2018, the case was medically confirmed.This unsolicited legal case from united states was received on 08-jan-2018 from patient.This case concerns 56 year old female patient (165 cm and 113.5 kg) who received treatment with synvisc one and experienced infection/infective arthritis(latency: 8 day), could not put pressure on knee (latency: 8 days), could not walk(latency: 9 days), pseudo sepsis arthritis/reaction, pain with range of motion, synovial fluid appearance turbid and synovial fluid wbc 79000 (latencies : 9 days), knee stiffness, activities of daily living impaired (latencies: 11 days), pneumonia (3months 2 days).Also, device malfunction (latency: 8 day) was identified for the reported lot number.Patient denied allergy to eggs but states that she has asthma and is allergic to feathers, plants and ragweed.Patient's past medical history included gallbladder problems, degenerative disc disease, heartburn, depression, anxiety disorder, alcohol use, gall bladder surgery/cholecystectomy, gastric bypass/tubal ligation gastric bypass, left thumb cmc arthritis, right knee arthroplasty, septic arthritis of right knee, peptic ulcer, hysterectomy, vitamin b 12 deficiency, osteoporosis, hypertension, mood disorder and balance disorder, nausea, diarrhea, sore throat, weakness, fatigue, erythema nodosum /red painful spots on legs, cough, myalgia, chronic back pain and right basal atelectasis, cellulitis left leg, leg swelling and probably trace edema.The patient's family history included diabetes mellitus (mother), cerebrovascular accident, renal failure (sibling and mother) and hypertension (father, mother and siblings).The patient's past medical treatment(s), vaccination(s) was not provided.Patient was reported to be a smoker (1 pack per day)and alcohol user.Concomitant medications included codeine phosphate, paracetamol (tylenol w/codeine) for pain; meloxicam (mobic); paracetamol, tramadol hydrochloride (ultram) for pain; naproxen; dexlansoprazole (dexilant); fluoxetine hcl ; methocarbamol; naloxone hydrochloride, pentazocine hydrochloride (pentazocine naloxone hydrochloride); cyclobenzaprine hcl; clarithromycin (claritin) ; sucralfate (sucralfate); azilsartan kamedoxomil (edarbi); cyanocobalamin; fluticasone propionate, salmeterol xinafoate (advair); furosemide (lasix) oxycodone hydrochloride, oxycodone terephthalate, paracetamol (percocet); zolpidem tartrate (ambien); albuterol sulfate ; diclofenac (voltaren); hydrochlorothiazide, triamterene (triamterene hctz); and salbutamol sulfate (ventolin hfa).On (b)(6) 2017 at 1:17 pm, the patient was administered with intra-articular synvisc one injection, at a dose of 6 ml once (batch/lot number: 7rsl021, expiry date: may-2020) for osteoarthritis in left knee.This was patient first time receiving the synvisc- one injection.She had received cortisone injections in the past and had received relief but that was short-lived.Left knee was prepped and anesthetized with 2 cc 1% lidocaine and then injected with synvisc one.Patient tolerated the procedure well.On (b)(6) 2017, patient went to emergency department with left knee/lower leg pain and swelling since night before.The doctor thought that there could possibly be pseudosepsis following injection.The patient had moderate amount of pain present.Patient was unable to bear a lot of weight the left knee was edematous and tender to touch patient was admitted to hospital on (b)(6) 2017.Patient was also able to able to work with physical therapy and able to ambulator with a rolling walker was able to walk approx 25 feet.A rolling walker was arranged for the patient at home.Pain medication was given.Patient continued to complain of some stiffness and left knee pain.Knee was aspirated and fluid cultured.Patient was given iv steroid, toradol, physical therapy, roller walker and percocet.Upon discharge the patient vitals were stable.It was reported that patient vital signs were stable and her pain was at tolerable level at this time.Both the cultures of the knee and blood were negative and the patient was discharged to home with home health and rolling walker.On (b)(6) 2017, after few hours of receiving injection, it was stated that day after the synvisc-one injection, patient knee started "acting up" with swelling/ left knee/lower leg swelling and she could not put any pressure on it.Pain score of 10/ left knee/lower leg pain.It was stated that by the 2nd or 3rd day, patient could not walk and called the ambulance to get her out of bed.Patient was admitted to the hospital on (b)(6) 2017 at 13:03 hours where she received antibiotics, fluids and pain medication.It was reported that the patient underwent synvisc one injection last week and developed pain , swelling , probable pseudo sepsis following synvisc one injection.Knee aspiration revealed increased white blood cell count but no evidence of bacteria.Left knee demonstrated mild swelling, tenderness, pain with range of motion, aspirate demonstrated a leukocytosis in the knee with elevated white blood cell count 79,000 and turbid synovial fluid.Patient did not do any exercise post injection, had a walker to use for ambulation and was unsure if she had a fever.Patient stated at the hospital they took blood work, drained the knee and performed cultures which showed infection.Patient stated that the swelling has gone down quite a bit, but she still had a pain score of 7 with weight bearing activities.Patient stated that her knee was worse than before she took the synvisc-one.On (b)(6) 2017, blood results revealed wbc 12.7 10*3/ul (high) , rbc 3.52 10*6/ul (low), hemoglobin 10.8 g/dl(low), hematocrit 31.8 (low) (%), red ell distribution width 14.6 (high)(%), neutrophil percentage 87.3( high) (%), lymphocyte percentage 8.1 (low) (%), monocyte percentage 3.9 (low) (%), eosinophil percentage 0.0(low) (%), neutrophil count 11.1 (high), immature granulocyte 0.06 (high), glucose 132 mg/dl (high), blood urea nitrogen 27 mg/dl(high), creatinine 1.4 mg/dl (high), albumin 2.4 g/dl (low) , alkaline phosphatase 198(high), alt 9 u/l (low), albumin globulin ratio 0.4 (low), cal ionized calcium 3.9 mg/dl (low), glomerular filtration rate 41 ml/min/1.73 m2(low), prothrombin time 11 second (high) partial thromboplastin time was 31 seconds (high).On (b)(6) 2017, lab tests reported were wbc 9.5 10*3/ul (high), rbc 3.77 10*6/ul (low), hemoglobin 11.4 g/dl(low), hematocrit 34.6 (low) (%), red cell distribution width 15.2 (high)(%), immature granulocyte 0.06 (high).At the time of discharge on (b)(6) 2017, patient reported of daily activities of living being impaired characterized by difficulty in climbing stairs, walking down the stairs, walking, bathing, difficulty in dressing and doing errands alone.Patient was discharged from the hospital on (b)(6) 2017 at 16:54 hours on wheelchair.On (b)(6) 2018, patient reported that she had reaction from injection.Patient's left knee was prepped and anesthetized with 2 cc 1% lidocaine, left knee was then injected with 5 cc 1%lidocaine and 60 mg depo medrol.Patient tolerated the procedure well.Patient taken naproxen and was supposed to go back to the hcp (health care professional) on (b)(6) 2018.Patient does not have prosthetic, defibrillator, pacemaker.Patient stated that disinfectant was used prior to synvisc-one injection.On (b)(6) 2018, patient came for follow up and reported that she felt she has pneumonia.As of (b)(6) 2018, it was reported that about a week ago the swelling got to be little bit worse than normal and then the past few days it started to turn red.On (b)(6) 2018, the pain was excruciating, could not walk, the redness flared up and became very warm to touch.This was happening in both legs and no trauma had occurred.There seemed to be an infection.Also reported that patient was voiding normally, had no kidney disease, no hepatic disease, no history of congestive heart failure (chf).Again patient was in excruciating pain with walking or movement.Corrective treatment: antibiotics, fluids and pain med cation (naproxen) for infection; walker for ambulation for could i not walk; lidocaine, buspirone, cyclobenzaprine, doxepin (doxepin hydrochloride), loratadine, omeprazole, oxycodone and acetaminophen, potassium chloride, vitamin d3, zolpidem; not reported for rest events.Outcome: not recovered for could not walk, pain with range of motion, red blood cell count decreased, hemoglobin low, hematocrit low, red cell distribution width increased, immature granulocyte count increased; recovering for infection/infective arthritis, device malfunction, could not put pressure on knee, unknown for rest of the events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation was completed, corrective and preventive actions would be implemented.Seriousness criterion: medically significant for infection/infective arthritis; hospitalization and intervention required for infection/infective arthritis, could not put pressure on knee, could not walk, pseudo sepsis arthritis/reaction; disability for activities of daily living impaired.Follow up was received on 29-jan-2018.No new information was received.Follow up was received on 06-feb-2018.Global ptc number was added.Additional information received on 30-oct-2018 from healthcare professional.Additional events of pseudo sepsis arthritis/reaction, pain with range of motion, knee stiffness, activities of daily living impaired were added with details.Concomitant medications were added.Medical history were added.Clinical course was updated and text amended accordingly.Additional information received on 30-oct-2018 from lawyer.Classification of the case was updated.Medical history and family history was added.Pregnancy status was updated.Verbatim of could not put pressure on knee/ unable to bear a lot of weight was updated.Additional event of synovial fluid appearance turbid and synovial fluid wbc 79000 was added with details.Clinical course was updated and text amended accordingly.Additional information was received on 12-nov-2018 from healthcare professional.Medical history was updated.Outcome of pain with range of motion and pain score of 10; left knee/lower leg pain/left knee tender to touch was updated from unknown to not recovered.Clinical course was updated and text amended accordingly.Follow up information received on 17-dec-2018.No new information was received.
|
