| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erythema (1840); Fatigue (1849); Inflammation (1932); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nausea (1970); Rash (2033); Therapeutic Response, Decreased (2271); Anxiety (2328); Arthralgia (2355); Joint Swelling (2356); Sleep Dysfunction (2517); No Code Available (3191)
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| Event Date 01/01/2017 |
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Event Type
Injury
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Event Description
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Bilateral knee pain/tenderness over medical joint/pain in the right knee [knee pain], recurrent swelling [knee swelling], trace effusion [knee effusion], crepitus [joint crepitation].Initial information received on (b)(6) 2018 regarding an unsolicited valid serious case received from a lawyer.This case involves a (b)(6) patient (b)(6) who experienced bilateral knee pain/tenderness over medical joint/pain in the right knee, recurrent swelling, trace effusion, crepitus while he was using medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history included colectomy and arthritis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing arthralgia, osteoarthritis, diabetes mellitus, alcohol use, joint effusion, joint swelling, joint range of motion decreased and non-tobacco user.On an unknown date in 2017, the patient received treatment with intra- articular synvisc injection with a dosage of 2 ml once a week for 3 weeks (with an unknown batch number) for bilateral osteoarthritis knee.On an unknown date in (b)(6) 2017, patient had severe bilateral knee pain and swelling.Patient still having effects from recent synvisc injection.Patient knees were examined that showed knee was in varus alignment and there was a trace effusion.There was tenderness over the medial joint line with range of motion was from 0-125 degrees.Along with there was crepitus with knee range of motion.The patient had normal quadriceps strength.Lachman, anterior drawer, and posterior drawer tests are (b)(6).There was no instability to varus or valgus stressing of the knee at 0 or 30 degrees.Mcmurray's test is (b)(6).Calves are soft and non-tender.Roman's sign is (b)(6).Patient was neurovasculary intact distally.Patient received both right and left knew corticosteroid mixture injection including triamcinolone, xylocaine, and marcaine.Sterile technique was maintained throughout the procedure.Patient tolerated the procedure well.Injection site was dressed in a sterile band-aid.It was reported that patient had recurrent swelling and pain in the right knee.Final diagnosis was crepitus, trace effusion, severe recurrent swelling and severe bilateral knee pain/tenderness over medical joint/pain in the right knee.Corrective treatment: corticosteroid injection: triamcinolone, lidocaine (xylocaine) and bupivacaine hydrochloride (marcaine) for bilateral knee pain/tenderness over medical joint/pain in the right knee, recurrent swelling, trace effusion and icing and elevating the affected area for, recurrent swelling, trace effusion; not reported for other event.The patient outcome is reported as not recovered / not resolved on an unknown date for bilateral knee pain/tenderness over medical joint/pain in the right knee, as not recovered / not resolved on an unknown date for recurrent swelling, as not recovered / not resolved on an unknown date for trace effusion, as not recovered / not resolved on an unknown date for crepitus seriousness criteria: intervention required for bilateral knee pain/tenderness over medical joint/pain in the right knee, recurrent swelling and trace effusion.
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Event Description
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Chondral necrosis [cartilage disorder] gait with a limp [limping] pseudo-sepsis reaction [pseudosepsis] ([pain upon movement], [knee swelling], [knee pain]) trace effusion [knee effusion] crepitus [joint crepitation] case narrative: initial information received on 02-oct-2018 regarding an unsolicited valid serious case received from a lawyer.This case involves a 49 years old male patient who experienced trace effusion, crepitus, pseudo-sepsis reaction, and chondral necrosis while he was using medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history included colectomy.Arthritis, bph (benign prostatic hypertrophy), herpes.The patient's past medical treatments included colonoscopy proc, closure ileostomy, cystoscopy insertion stent adult, resection intestinal (colon sigmoid), laproscopic, hemicolectomy laparascopic right and irrigation & debridement abscess.His past vaccination(s) was not provided.His family history included arthritis and diabetes.At the time of the event, the patient had ongoing arthralgia, osteoarthritis, diabetes mellitus, alcohol use, joint effusion, joint swelling, joint range of motion decreased, non-tobacco user, diverticulitis.On 16-jan-2017, patient had x-ray examination of knee which showed that no acute fracture or dislocation.Moderate osteoarthritis of both knees noted with joint space lost worst in the medial compartments bilaterally his concomitant medication included rabeprazole sodium (aciphex), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (adderall), lactobacillus acidophilus, oxycodone, sildenafil and tramadol and codeine.On (b)(6) 2017 , the patient received treatment with intra- articular synvisc injection with a dosage of 2 ml once a week for 3 weeks (with an unknown batch number, there will be no information available on the batch number for this case) for bilateral osteoarthritis knee.On (b)(6) 2017 , patient had severe bilateral knee pain and swelling.Patient was still having effects from recent synvisc injection.Patient knees were examined that showed knee was in varus alignment and there was a trace effusion.There was tenderness over the medial joint line with range of motion was from 0-125 degrees.Along with there was crepitus with knee range of motion.The patient had normal quadriceps strength.Lachman, anterior drawer, and posterior drawer tests are negative.There was no instability to varus or valgus stressing of the knee at 0 or 30 degrees.Mcmurray's test is negative.Calves are soft and non-tender.Roman's sign is negative.Patient was neurovasculary intact distally.The same day, patient received both right and left knew corticosteroid mixture injection including triamcinolone, xylocaine, and marcaine.Sterile technique was maintained throughout the procedure.Patient tolerated the procedure well.Injection site was dressed in a sterile band-aid.It was reported that patient had recurrent swelling and pain in the right knee.On his visit of (b)(6) 2018 in healthcare facility, he was observed with pseudo-sepsis reaction.He had recurrent swelling and increasing pain since that time.He complained 9 out of 10 sharp pain right greater than left.Pain radiated posteriorly worse with stairs and chairs better with the rest.He was ambulating with heel towards getting a gait with a limp on the right side of muscle tone and was given cortisone in right knee.On 14-mar-2018, patient had x-ray examination of knee which showed moderate osteoarthritis of both knees are noted with joint space lost worst in the medial compartments.On 03-jan-2019, patient had a visit in healthcare facility and reported to have bilateral knee pain and swelling post total knee replacement.On an unknown date, patient had x-ray examination of knee which showed severe acceleration and complete obliteration.On 06-mar-2019, patient when presented to medical facility, it was reported that patient was suffering from chondral necrosis which ultimately necessitated him to have bilateral early knee replacements.Action taken: unknown.Corrective treatment: bilateral knee replacement, corticosteroid injection: triamcinolone, lidocaine (xylocaine) and bupivacaine hydrochloride (marcaine) for bilateral knee pain/tenderness over medical joint/pain in the right knee, recurrent swelling, trace effusion and icing and elevating the affected area for, recurrent swelling, trace effusion, gait with a limp and pseudo-sepsis reaction; not reported for other event the patient outcome is reported as as not recovered / not resolved on an unknown date for trace effusion, as not recovered / not resolved on an unknown date for crepitus; unknown for chondral necrosis, gait with a limp and pseudo-sepsis reaction.Seriousness criteria: intervention required for trace effusion, pseudo-sepsis reaction, chondral necrosis and gait with a limp.A product technical complaint (ptc) was initiated on 25-apr-2019 for synvisc.Batch number unknown, global ptc number: 58079.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 25-apr-2019.No safety issues were indicated in this review.Additional information was received on 04-apr-2019 from the lawyer.Start date for the suspect product was updated.Medical history was updated.Concomitant medications were added.Additional events of pseudo-sepsis reaction, chondral necrosis and gait with a limp was added.Start date for the events of bilateral knee pain/tenderness over medical joint/pain in the right knee and recurrent swelling was updated.Bilateral knee pain/tenderness over medical joint/pain in the right knee, recurrent swelling was updated as symptom of pseudo-sepsis reaction.Clinical course updated, and text amended accordingly.Additional information was received on 25-apr-2019.Global ptc number and ptc results were added.Text amended accordingly.
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Event Description
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Chondral necrosis [cartilage disorder] gait with a limp [limping] pseudo-sepsis reaction [pseudosepsis] ([pain upon movement], [knee swelling], [knee pain]) trace effusion [knee effusion] crepitus [joint crepitation] case narrative: initial information received on 02-oct-2018 regarding an unsolicited valid serious case received from a lawyer.This case involves a 49 years old male patient who experienced trace effusion, crepitus, pseudo-sepsis reaction, and chondral necrosis while he was using medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history included colectomy.Arthritis, bph (benign prostatic hypertrophy), herpes.The patient's past medical treatments included colonoscopy proc, closure ileostomy, cystoscopy insertion stent adult, resection intestinal (colon sigmoid), laproscopic, hemicolectomy laparascopic right and irrigation & debridement abscess.His past vaccination(s) was not provided.His family history included arthritis and diabetes.At the time of the event, the patient had ongoing arthralgia, osteoarthritis, diabetes mellitus, alcohol use, joint effusion, joint swelling, joint range of motion decreased, non-tobacco user, diverticulitis.On (b)(6) 2017, patient had x-ray examination of knee which showed that no acute fracture or dislocation.Moderate osteoarthritis of both knees noted with joint space lost worst in the medial compartments bilaterally his concomitant medication included rabeprazole sodium (aciphex), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (adderall), lactobacillus acidophilus, oxycodone, sildenafil and tramadol and codeine.On (b)(6) 2017, the patient received treatment with intra- articular synvisc injection with a dosage of 2 ml once a week for 3 weeks (with an unknown batch number) for bilateral osteoarthritis knee.On (b)(6) 2017, patient had severe bilateral knee pain and swelling.Patient was still having effects from recent synvisc injection.Patient knees were examined that showed knee was in varus alignment and there was a trace effusion.There was tenderness over the medial joint line with range of motion was from 0-125 degrees.Along with there was crepitus with knee range of motion.The patient had normal quadriceps strength.Lachman, anterior drawer, and posterior drawer tests are negative.There was no instability to varus or valgus stressing of the knee at 0 or 30 degrees.Mcmurray's test is negative.Calves are soft and non-tender.Roman's sign is negative.Patient was neurovasculary intact distally.The same day, patient received both right and left knew corticosteroid mixture injection including triamcinolone, xylocaine, and marcaine.Sterile technique was maintained throughout the procedure.Patient tolerated the procedure well.Injection site was dressed in a sterile band-aid.It was reported that patient had recurrent swelling and pain in the right knee.On his visit of (b)(6) 2018 in healthcare facility, he was observed with pseudo-sepsis reaction.He had recurrent swelling and increasing pain since that time.He complained 9 out of 10 sharp pain right greater than left.Pain radiated posteriorly worse with stairs and chairs better with the rest.He was ambulating with heel towards getting a gait with a limp on the right side of muscle tone and was given cortisone in right knee.On (b)(6) 2018, patient had x-ray examination of knee which showed moderate osteoarthritis of both knees are noted with joint space lost worst in the medial compartments.On 03-jan-2019, patient had a visit in healthcare facility and reported to have bilateral knee pain and swelling post total knee replacement.On an unknown date, patient had x-ray examination of knee which showed severe acceleration and complete obliteration.On (b)(6) 2019, patient when presented to medical facility, it was reported that patient was suffering from chondral necrosis which ultimately necessitated him to have bilateral early knee replacements.Action taken: unknown.Corrective treatment: bilateral knee replacement, corticosteroid injection: triamcinolone, lidocaine (xylocaine) and bupivacaine hydrochloride (marcaine) for bilateral knee pain/tenderness over medical joint/pain in the right knee, recurrent swelling, trace effusion and icing and elevating the affected area for, recurrent swelling, trace effusion, gait with a limp and pseudo-sepsis reaction; not reported for other event.The patient outcome is reported as as not recovered not resolved on an unknown date for trace effusion, as not recovered not resolved on an unknown date for crepitus; unknown for chondral necrosis, gait with a limp and pseudo-sepsis reaction.Seriousness criteria: intervention required for trace effusion, pseudo-sepsis reaction, chondral necrosis and gait with a limp.Additional information was received on 04-apr-2019 from the lawyer.Start date for the suspect product was updated.Medical history was updated.Concomitant medications were added.Additional events of pseudo-sepsis reaction, chondral necrosis and gait with a limp was added.Start date for the events of bilateral knee pain/tenderness over medical joint/pain in the right knee and recurrent swelling was updated.Bilateral knee pain/tenderness over medical joint/pain in the right knee, recurrent swelling was updated as symptom of pseudo-sepsis reaction.Clinical course updated, and text amended accordingly.
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Event Description
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Chondral necrosis [chondronecrosis], need assistance with standing, walking or toileting/bathing, dressing, personal hygiene [loss of personal independence in daily activities] ([difficulty in standing]), postoperative acute kidney injury possibly secondary to obstructive uropathy [acute kidney injury] ([urinary retention postoperative]), gait with a limp/other abnormalities of gait/difficulty in walking [gait abnormal], infection [arthritis infective], pseudo-sepsis reaction [pseudosepsis] ([pain upon movement], [knee effusion], [arthralgia aggravated], [knee swelling]), osteoarthritis is severely accelerated/bilateral post traumatic osteoarthritis of knee [osteoarthritis aggravated] ([subtherapeutic response], [joint crepitation]), dry cough [dry cough], multiple mouth sores [sores mouth], foot dryness/impaired skin integrity: dryness b/l heels [dry skin], antemor chest redness/erythema surrounding skin both knees and shin [redness], scab on right/left shin [scab], mobility slightly limited: makes frequent though slight changes in body or extremity position independently [mobility decreased], trouble falling or staying asleep, or sleeping too much [sleep disturbance] , feeling tired or having little energy [tiredness], feeling tired or having little energy [energy decreased] , muscle weakness (generalized) [generalized muscle weakness], acute post procedural pain [post procedural pain] , slow transit constipation [slow transit constipation] , impaired vision [visual impairment], anxiety disorder due to known physiological condition [anxiety] , postoperative anemia and leukocytosis most likely reactive [anemia postoperative] , postoperative anemia and leukocytosis most likely reactive [leukocytosis], self inflicted corneal abrasion in right eye secondary to combative awakening from anesthesia in operating room [corneal abrasion], rash on back and erythema surrounding skin [rash erythematous] , foot edema/edema in bilateral legs [oedema peripheral] , nausea [nausea], muscle spasm [muscle spasm], and insomnia [insomnia].Case narrative: initial information received from united states on 02-oct-2018 regarding an unsolicited valid serious case received from a lawyer.This case involves a 49 years old male patient (180 cm and 104.5 kg) who experienced chondral necrosis, need assistance with standing, walking or toileting/bathing, dressing, personal hygiene, postoperative acute kidney injury possibly secondary to obstructive uropathy, gait with a limp/other abnormalities of gait/difficulty in walking, infection, pseudo-sepsis reaction, osteoarthritis is severely accelerated/bilateral post traumatic osteoarthritis of knee, dry cough, multiple mouth sores, foot dryness/impaired skin integrity: dryness b/l heels, antemor chest redness/erythema surrounding skin both knees and shin, scab on right/left shin, mobility slightly limited: makes frequent though slight changes in body or extremity position independently, trouble falling or staying asleep, or sleeping too much, feeling tired or having little energy, muscle weakness (generalized), acute post procedural pain, slow transit constipation, impaired vision, anxiety disorder due to known physiological condition, postoperative anemia and leukocytosis most likely reactive, insomnia, rash on back and erythema surrounding skin and foot edema/edema in bilateral legs, nausea, muscle spasm, self inflicted corneal abrasion in right eye secondary to combative awakening from anesthesia in operating room while he was using medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included resisted rom (range of motion), arthritis, genital herpes (herpesviral infection of perianal skin and rectum), absent cartilage on the medial condyles of his knees, broad full thickness cartilage loss overlying the medial femoral condyle and medial tibial plateau and complex degenerative tearing of the medial meniscus, urinary frequency, urinary retention, corneal abrasion.The patient's past procedural history included colectomy, hemicolectomy laparascopic right ((b)(6) 2016) and irrigation & debridement abscess ((b)(6) 2016), cystoscopy insertion stent adult ((b)(6) 2016), resection intestinal (colon sigmoid), laproscopic ((b)(6) 2016), colonoscopy proc ((b)(6) 2016), closure ileostomy ((b)(6) 2016).At the time of the event, the patient had ongoing bilateral knee pain/tenderness over medial joint and around patella, osteoarthritis/bilateral knee osteoarthritis, small effusion/large joint effusion, osa (obstructive sleep apnea syndrome), soft tissue swelling around knee, asthma, diverticulitis of sigmoid colon, bph (benign prostatic hypertrophy) with lower urinary tract symp (symptom), add (attention deficit hyperactivity disorder), gerd (gastrooesophageal reflux disease), mild synovitis/debris.On (b)(6) 2017, patient had x-ray examination of knee which showed that no acute fracture or dislocation.Moderate osteoarthritis of both knees noted with joint space lost worst in the medial compartments bilaterally.Patient was non-smoker and drinks occasionally.The patient denied substance abuse.His family history included arthritis and diabetes, positive for father having phlebitis, heart valve abnormality, mother had osteoarthritis and fibromyalgia.His concomitant medication included rabeprazole sodium (aciphex); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (adderall); lactobacillus acidophilus; oxycodone; sildenafil; tramadol; codeine; morniflumate (flomax) for urinary retention and bph (benign prostatic hypertrophy) with lower urinary tract symp; alprazolam (xanax); dextroamphetamine (dexamfetamine) for add; pantoprazole for gerd; tamsulosin for bph (benign prostatic hypertrophy) with lower urinary tract symp; valaciclovir hydrochloride (valtrex) for genital herpes (herpesviral infection of perianal skin and rectum) and apixaban for dvt (deep vein thrombosis) prophylaxis, fluticasone propionate; salbutamol sulfate (ventolin hfa); azithromycin; azelastine hcl; tadalafil (cialis); anastrozole; doxycycline monohydrate; and oxycodone hydrochloride, paracetamol (oxycodone and acetaminophen.On (b)(6) 2017, the patient received treatment with intra- articular hylan g-f 20, sodium hyaluronate injection with a dosage of 2 ml once a week for 3 weeks (with an unknown batch number, there will be no information available on the batch number for this case) for bilateral primary osteoarthritis knee.On (b)(6) 2017 during doctor's visit, after unknown latency, patient was noted to have severe bilateral knee pain and swelling (arthralgia; joint swelling) (onset date: 2017).Patient was still having effects from recent hylan g-f 20, sodium hyaluronate injection.Patient knees were examined that showed knee was in varus alignment and there was a trace effusion (joint effusion) (onset date: 2017).There was tenderness over the medial joint line with range of motion was from 0-125 degrees.Along with there was crepitus (joint noise) with knee range of motion (onset date: 2017).The patient had normal quadriceps strength.Lachman, anterior drawer, and posterior drawer tests are negative.There was no instability to varus or valgus stressing of the knee at 0 or 30 degrees.Mcmurray's test was negative.Calves are soft and non-tender.Homan's sign is negative.Patient was neurovasculary intact distally.The same day, patient received both right and left knee corticosteroid mixture injection including lidocaine (xylocaine), triamcinolone, bupivacaine hydrochloride (marcaine).Sterile technique was maintained throughout the procedure.Patient tolerated the procedure well.Injection site was dressed in a sterile band-aid.It was reported that patient had recurrent swelling and pain in the right knee.On his visit of (b)(6) 2018 in healthcare facility, he was observed with pseudo-sepsis reaction (pseudosepsis; event assessed as serious due to intervention and hospitalization).The patient was aspirated three times over 3 days and injection of steroid was carried out.He had recurrent swelling and increasing pain since that time.He complained 9 out of 10 sharp pain right greater than left.Pain radiated posteriorly worse with stairs and chairs (pain) better with the rest.Anti-inflammatories had not been helpful since the patient had diverticulitis with resection of sigmoid colon so anti-inflammatories should be avoided.He was ambulating with heel towards getting a gait with a limp (gait disturbance; serious event due to disability) on the right side of muscle tone and was given cortisone in right knee, fluid was aspirated and sent for cell count culture and crystals.On (b)(6) 2018, patient had x-ray examination of knee which showed moderate osteoarthritis of both knees are noted with joint space lost worst in the medial compartments.On (b)(6) 2018 visit, patient had severe and debilitating both knee pain affecting his daily activities, had difficulty standing for long period of time (dysstasia) and walking for long period of time (gait disturbance), felt that right knee was worse than left, current pain level 10/10, average was 8/10, symptoms occurring daily while walking, sitting, bending, standing and lifting.Symptoms relieved by acetaminophen, exercise regimen, ice, non-steroidal anti-inflammatory drugs, opioid analgesics, rest, physical therapy.On (b)(6) 2018, patient was hospitalized for bilateral total knee replacement.Intraoperative findings included medium joint effusion and synovitis.On an unknown date, after unknown latency, patient had nausea, insomnia, muscle spasm (muscle spasms).Recently on unknown date in 2018, complained of dry cough (cough) and multiple mouth sores (stomatitis), no fever.On admission it was noted, patient needed assistance with sanding, walking, toileting (loss of personal independence in daily activities, serious event due to disability), had no falls in last 6 months, was not ambulatory or self-mobile in wheelchair.Worst level of pain reported to be 5-10, best level was 1-5 and acceptable was 1-3 and exacerbating factors were movement, walking, bending.Patient had foot dryness/dryness b/l (bilateral) heels (dry skin), foot edema (edema peripheral), antemor chest erythema, rash on back, scab on both shin, erythema surrounding both knees, back, both shin (erythema; rash erythematous, scab; onset, latency: unknown).Patient walked occasionally had slightly limited mobility: makes frequent though slight changes in body or extremity position independently (mobility decreased; onset, latency: unknown).On an unknown date in (b)(6) 2018, red blood cell count (rbc count) was 3.80 m/ul (low; reference: 4.20-5.80); hemoglobin 8.4 g/dl (low; reference: 13.0-17.0); hematocrit 28.1% (low; reference: 39.0-50.0), mean cell volume 73.9fl (low; reference: 80.0-100.0), mean cell hemoglobin 22.1 pg (low; reference: 27.0-34.0), mean cell hemoglobin concentration 29.9 gm/dl (low; reference: 32.0-36.0), red cell distribution width 17.4% (high; reference: 10.3-14.5), glucose, serum 175 mg/dl (high; reference: 70-99).Patient was noted to have slow transit constipation (constipation; onset, latency: unknown) and was told to have adequate fluid intake.Patient was also advised to observe signs/symptoms of bruising bleeding, hematoma and was placed on deep vein thrombosis (dvt) prophylaxis.Patient had impaired mobility, transfers, walking, needed assistance with bathing, dressing, personal hygiene, usual home routine and had walker, wheelchair for primary locomotion.Patient had occupational and physical therapy.Patient had impaired vision (visual impairment) and was using glasses (onset, latency: unknown).Psychotherapy was ordered for anxiety disorder due to known physiological condition (anxiety; onset, latency: unknown).Patient was reported to have trouble falling or staying asleep or sleeping too much (sleep disorder; frequency of 2-6 days) and was feeling tired or having little energy (fatigue; frequency of 7-11 days).On (b)(6) 2018, patient was noted to have postoperative urinary retention (urinary retention) (latency: approximately 1 year).Patient had a foley catheter placed for retention and had a slight increase in creatinine.Patient was complaining of increasing pain in both knees.Patient also had postoperative acute kidney injury, possibly secondary to obstructive uropathy (acute kidney injury; medically significant), postoperative anemia (asymptomatic) and leukocytosis most likely reactive (anaemia postoperative, leukocytosis), postoperative pain (procedural pain) which was getting better now (onset: (b)(6) 2018; latency: approximately 1 year).Once renal function normalized, would be given trial of void.Patient sustained self inflicted corneal abrasion in right eye secondary to combative awakening from anesthesia in operating room, was evaluated and treated by ophthalmology (corneal abrasion; latency: approximately 1 year).On (b)(6) 2018, patient was discharged and was also diagnosed with muscular weakness (generalized) (latency: 1 year 25 days) and was noted to be independent for all adls (activities of daily living), had other abnormalities of gait and mobility.Patient was discharged to home with his spouse and attend out outpatient therapy.On (b)(6) 2018 follow up visit, patient doing very well, slowly returning to previous activities, working with therapy and exercise, noticed a great progression but was doing well after surgery, had constipation at the time.X-ray of both knee showed: hardware in place, no evidence of fracture dislocation or loosening of any hardware.On (b)(6) 2019, patient had a visit in healthcare facility and reported to have bilateral knee pain and swelling post total knee replacement.On an unknown date, patient had x-ray examination of knee which showed severe acceleration and complete obliteration.On (b)(6) 2019 visit, doing well, continued to go to therapy, complained of intermittent swelling to right knee due to extensive walking while working, pain severity 1/10, x-ray showed: hardware in good position, no obvious fractures and good overall alignment, knee replacement grossly intact in anatomic alignment, good bonne prosthesis interface, no gross evidence of prosthetic failure, good overall alignment.It was reported that the patient some mild to moderate osteoarthritis of his knees but certainly was not a candidate for knee replacements but due to the injections in his knee, he had severe reaction and ultimately developed chondral necrosis.On (b)(6) 2019, patient when presented to medical facility, that patient was suffering from chondral necrosis (chondronecrosis; event assessed as serious: medically significant; hospitalization, intervention required), osteoarthritis was severely accelerated following the hylan g-f 20, sodium hyaluronate injections (osteoarthritis; event assessed as serious: medically significant; hospitalization, intervention required), and both knee aspirated, significant post injection pain, x-ray showed acceleration and complete obliteration, the patient ultimately had no choice but to undergo bilateral early total knee replacements to relive his pain.It was reported that there was not much improvement (therapeutic response decreased) after hylan g-f 20, sodium hyaluronate injections and patient had infection (arthritis infective; event assessed as medically significant).On (b)(6) 2019, upon follow up visit mentioned patient was exercising, taking no pain medications, current pain level 0/10 and maximum was 2/10.Symptoms occur while walking and were intermittent.Action taken: not applicable for postoperative acute kidney injury possibly secondary to obstructive uropathy, acute post procedural pain, postoperative anemia and leukocytosis most likely reactive, self inflicted corneal abrasion in right eye secondary to combative awakening from anesthesia in operating room, unknown for rest of the events.Corrective treatment: polyethylene glycol 3350, docusate sodium (colace), sennoside a+b (senna) for slow transit constipation, alprazolam for insomnia, anxiety disorder due to known physiological condition, icing and elevating the affected area, bilateral total knee replacement, acetaminophen, hydromorphone hydrochloride (dilaudid), lidocaine (xylocaine), triamcinolone, bupivacaine hydrochloride (marcaine), cortisone for pseudo-sepsis reaction, celecoxib (celebrex) for acute post procedural pain and pseudo-sepsis reaction, guaifenesin for dry cough, promethazine for nausea, ergocalciferol, retinol (a & d) for foot dryness/impaired skin integrity: dryness b/l heels, paracetamol (tylenol) for acute post procedural pain and diazepam for muscle spasms, bilateral total knee replacement for chondral necrosis, osteoarthritis is severely accelerated/bilateral post traumatic osteoarthritis of knee; foley catheter for postoperative acute kidney injury possibly secondary to obstructive uropathy, glyoxide for multiple mouth sores; glasses for impaired vision; ciprofloxacin for corneal abrasion; wheelchair, lidocaine, triamcinolone, bupivacaine hydrochloride for gait with a limp/other abnormalities of gait/difficulty in walking not reported for rest of the events.Outcome: recovering for acute post procedural pain, recovered for gait with a limp/other abnormalities of gait/difficulty in walking, need assistance with standing, walking or toileting/bathing, dressing, personal hygiene, rash on back and erythema surrounding skin, slow transit constipation, postoperatively developed urinary retention, nausea, difficulty standing for long period; not recovered for bilateral knee pain/tenderness over medial joint/pain in the right knee/increasing pain in both knees, recurrent swelling/bilateral knee swelling, trace effusion, crepitus, pain radiates posteriorly worse with stairs/exacerbating factors: movement, walking, bending; unknown for rest of the events.A product technical complaint (ptc) was initiated on 25-apr-2019 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 (corrective and preventive action) 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 (non conformances report) 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 25-apr-2019.No safety issues were indicated in this review.Additional information was received on 04-apr-2019 from the lawyer.Start date for the suspect product was updated.Medical history was updated.Concomitant medications were added.Additional events of pseudo-sepsis reaction, chondral necrosis and gait with a limp was added.Start date for the events of bilateral knee pain/tenderness over medical joint/pain in the right knee and recurrent swelling was updated.Bilateral knee pain/tenderness over medical joint/pain in the right knee, recurrent swelling was updated as symptom of pseudo-sepsis reaction.Clinical course updated, and text amended accordingly.Additional information was received on 25-apr-2019 from healthcare professional.Global ptc number and ptc results were added.Text amended accordingly.Additional information was received on 21-sep-2020 from lawyer.Events of need assistance with standing, walking or toileting/bathing, dressing, personal hygiene, postoperative acute kidney injury possibly secondary to obstructive uropathy, infection, osteoarthritis is severely accelerated/bilateral post traumatic osteoarthritis of knee, dry cough, multiple mouth sores, foot dryness/impaired skin integrity: dryness b/l heels, antemor chest redness/erythema surrounding skin both knees and shin, scab on right/left shin, mobility slightly limited: makes frequent though slight changes in body or extremity position independently, trouble falling or staying asleep, or sleeping too much, feeling tired or having little energy, muscle weakness (generalized), acute post procedural pain, slow transit constipation, impaired vision, anxiety disorder due to known physiological condition, postoperative anemia and leukocytosis most likely reactive, insomnia, rash on back and erythema surrounding skin and foot edema/edema in bilateral legs, nausea, muscle spasm, self inflicted corneal abrasion in right eye secondary to combative awakening from anesthesia in operating room were added with details.Medical history, seriousness criteria, concomitant medications updated.Clinical course updated.Text amended accordingly.
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