| Lot Number 7RSL021 |
| Device Problems
Nonstandard Device (1420); Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
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| Patient Problems
Arthralgia (2355); Malaise (2359); Reaction, Injection Site (2442); No Code Available (3191)
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| Event Date 12/01/2017 |
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Event Type
Injury
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Event Description
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This unsolicited case from united states was received on (b)(6) 2017 from a healthcare professional.This case concerns a male patient (age unspecified) who received treatment with synvisc one and after unknown latency the patient was not feeling good; also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication or concurrent condition was provided.On an unknown date in (b)(6) 2017 (last week), the patient initiated treatment with single intra-articular synvisc one injection (expiry date, indication, dose and frequency : unknown) (batch/lot number: 7rsl021).On an unknown date in (b)(6) 2017, (unknown latency after starting treatment), the patient was not feeling good.Corrective treatment: not reported for both.Outcome: unknown for both.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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 25-dec-2017: this case concerns a patient who received treatment with synvisc one injection from the recalled lot and later experienced being feeling unwell.Although exact event onset date has not been provided in the case, temporal relationship can still be established between the event and the suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, the pharmacological plausibility of the events to the product cannot be excluded.
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Event Description
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This unsolicited case from united states was received on 18-dec-2017 from a healthcare professional.This case concerns a (b)(6) years old male patient who received treatment with synvisc one and after unknown latency the patient was not feeling good, difficulty bending the knee, tenderness in the knee, knee swelling and fluid was removed from the knee; also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication or concurrent condition was provided.The patient had past treatment with synvisc one injection.The patient was not being treated for diabetes or any other chronic disease.On (b)(6) 2017 (last week), the patient initiated treatment with single intra-articular synvisc one injection once (expiry date, indication, dose: unknown) (batch/lot number: 7rsl021).On an unknown date in (b)(6) 2017, (unknown latency after starting treatment), the patient was not feeling good.On an unknown, the patient experienced tenderness, swelling and difficulty bending the knee.It was reported that the physician offered to aspirate the knee, but the patient declined.She prescribed ice, rest and nabumetone 1000mg twice daily.As on (b)(6) 2017, the patient's symptoms persisted.On an unknown date in (b)(6) 2017, patient was seen in the office and the fluid was removed from the knee and sent for culture.No results from the culture are known at this time.No additional information was provided for this report.Corrective treatment: ice, rest and nabumetone 1000mg for tenderness in the knee, knee swelling and fluid was removed from the knee; not reported for rest of the events.Outcome: unknown for device malfunction and not feeling good; not recovered for rest of the 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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction additional information was received on 19-dec-2017 from the patient.The additional events of difficulty bending the knee, tenderness in the knee, knee swelling and fluid was removed from the knee were added with details.The suspect product start date was updated from dec-2017 to 14-dec-2017.Clinical course updated.Information regarding past treatment with synvisc one was added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 25-dec-2017: this case concerns a patient who received treatment with synvisc one injection from the recalled lot and later experienced being feeling unwell.Although exact event onset date has not been provided in the case, temporal relationship can still be established between the event and the suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, the pharmacological plausibility of the events to the product cannot be excluded.
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Event Description
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Device malfunction [device malfunction] , sepsis of the right knee joint [septic joint] , difficulty with ambulation [difficulty in walking], not feeling good [feeling unwell] , difficulty bending the knee [joint range of motion decreased] , edema in right knee [injection site edema] , tenderness in the knee/ right knee pain [knee pain] ([knee swelling], [knee effusion]).Case narrative: this unsolicited legal case from united states was received on 18-dec-2017 from a healthcare professional.This case concerns a 52 years old male patient who received treatment with synvisc one and after unknown latency the patient was not feeling good, difficulty bending the knee, and fluid was removed from the knee, sepsis of the right knee joint, difficulty with ambulation, edema in right knee; also, device malfunction was identified for the reported lot number.No past drug was provided.The patient had past treatment with synvisc one injection.The patient was not being treated for diabetes or any other chronic disease.Concomitant medications include amlodipine besilate (norvasc); nabumetone (relafen); cetirizine hydrochloride (zyrtec [cetirizine hydrochloride]); and atorvastatin (liptor).The patient's past vaccination(s) included influenza vaccine.At the time of the event, the patient had ongoing arthroscopy, gastroesophageal reflux disease, osteoarthritis, seasonal allergy, chest pain, hypertension, deep vein thrombosis, sleep apnoea syndrome, oxygen saturation decreased, drug allergy-bactrim, clindamycin and keflex with full body rash, synvisc allergy, dyslipidaemia, rheumatoid arthritis and meniscus removal, alcohol use, non smoker, obesity, renal stones, renal disorder.On (b)(6) 2017 (last week), the patient initiated treatment with single intra-articular synvisc one injection once (expiry date, indication, dose: unknown) (batch/lot number: 7rsl021).On an unknown date in (b)(6) 2017, (unknown latency after starting treatment), the patient was not feeling good.On an unknown, the patient experienced tenderness, swelling and difficulty bending the knee.It was reported that the physician offered to aspirate the knee, but the patient declined.Soon after the injection, he developed knee swelling and pain.She prescribed ice, rest and nabumetone 1000mg twice daily.As on (b)(6) 2017, the patient's symptoms persisted.On an unknown date in (b)(6) 2017, patient was seen in the office and the fluid was removed from the knee and sent for culture.No results from the culture are known at this time.No additional information was provided for this report.On an unknown date, the patient had sepsis of the right knee joint, edema in right knee, after unknown latency.The patient also had difficulty with ambulation to the point that he had to use crutches.The knee was aspirated three different times after he developed swelling.Relevant laboratory test results included: arthroscopy - on an unknown date: [unknown].Aspiration joint - on an unknown date: [3 times].Culture - on (b)(6) 2017: [negative].Corrective treatment: ice, rest and nabumetone 1000mg for tenderness in the knee, amoxcillin-clavunic acid(augmentin) and ertapenem for septic arthritis; not reported for rest of the events.Outcome: unknown for device malfunction, not feeling good, difficulty with ambulation, edema in right knee; recovered for septic arthritis and difficulty bending the knee; not recovered for rest of the events seriousness criterion: medical significant, disability for device malfunction; disability for difficulty ambulation; medically significant for septic arthritis.A global pharmaceutical technical complaint was initiated with ptc number: 51425 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 is completed, corrective and preventive actions would be implemented.Additional information was received on 19-dec-2017 from the patient.The additional events of difficulty bending the knee, tenderness in the knee, knee swelling and fluid was removed from the knee were added with details.The suspect product start date was updated from (b)(6) 2017 to (b)(6) 2017.Clinical course updated.Information regarding past treatment with synvisc one was added.Text was amended accordingly.Additional information was received on 12-jan-2018.The global ptc number was added.Text amended accordingly.Additional information was received on 07-feb-2019 from lawyer.Event of sepsis of the right knee joint, difficulty with ambulation, edema in right knee added.Labs added.Medical history updated.Concomitant medications added.Clinical course was updated and text amended accordingly.
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Event Description
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Device malfunction [device malfunction] difficulty with ambulation [difficulty in walking] possible sepsis of the right knee joint/pyogenic arthritis of right knee joint [pyogenic arthritis] ([aching (r) knee], [injection site edema], [swelling of r knee], [knee effusion]) not feeling good [feeling unwell] difficulty bending the knee [joint range of motion decreased] case narrative: this unsolicited legal case from united states was received on (b)(6) 2017 from a healthcare professional.This case concerns a 52 years old male patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and experienced sepsis of the right knee joint/pyogenic arthritis of right knee joint (latency: 4 days), difficulty with ambulation (latency: 6 days), not feeling good (latency: unknown), difficulty bending the knee (latency: 1 day).Also, device malfunction was identified for the reported lot number.The past medical history of the patient included right knee arthroscopy on (b)(6) 2014, gerd on (b)(6) 2015, right knee meniscetomy, complex sleep apnea syndrome, renal stones, renal disorder.The concurrent conditions included osteoarthritis since (b)(6) 2015, and has issues with asthma, seasonal allergies since (b)(6) 2015, atypical chest pain since 04-(b)(6) 2017, hypertension (chronic) since (b)(6) 2012, dvt since (b)(6) 2017, alcohol use since (b)(6) 2017 with 1.2 oz total alcohol per week; 2 cans of beer, nocturnal oxygen desaturation since (b)(6) 2017, synvisc allergy, dyslipidemia since (b)(6) 2009, rheumatoid arthritis since (b)(6) 2013, obesity, non-smoker, allergy to bactrim, allergy to clindamycin and allergy to keflex.Family history included prostate cancer.Vaccination history of influenza and influenza tiv.The patient had past treatment with synvisc one injection.The patient was not being treated for diabetes or any other chronic disease.Concomitant medications include amlodipine besilate (norvasc); nabumetone (relafen); cetirizine hydrochloride (zyrtec [cetirizine hydrochloride]), atorvastatin (liptor), omeprazole (prilosec [omeprazole]); meloxicam (mobic); and zolpidem tartrate (ambien).On (b)(6) 2017 (last week), the patient initiated treatment with intra-articular with hylan g-f 20, sodium hyaluronate injection once at a dose of 6 ml (expiry date, indication, dose: unknown) (batch/lot number: 7rsl021, expiration date:(b)(6) 2020) for primary osteoarthritis in the right knee for osteoarthritis.Medial aspect of bilateral knees was prepped with betadine, local anesthetic with ethyl chloride and xylocaine and using sterile technique, injected 40 mg of depomedrol via medial approach into the left knee and injected 48 mg of synvisc one via medial approach into the right knee.The patient tolerated the procedure well, was observed in the office and there were no complications.Patient was asked to rest bilateral knees for 3 days.On (b)(6) 2017, patient experienced tenderness/pain (latency: 1 day), swelling in right knee and difficulty bending the knee.It was reported that the physician offered to aspirate the knee, but the patient declined.Soon after the injection, he developed knee swelling and pain.Patient was prescribed ice, rest and nabumetone 1000mg twice daily.The same day, patient reported to the office and the fluid was removed from the knee and sent for culture.However over the course of the weekend, patients right knee improved only a little but still was quite swollen and painful.As on (b)(6) 2017, the patient's symptoms persisted.On (b)(6) 2017, there was tenderness on palpation along the joint line on the right knee.The same day, it was confirmed that the patient had received the contaminated synvisc one which was found to be contaminated with methylobacterium thiocyanatum.The same day, patient was put on iv levaquin therapy as it was suspected that he may have possible sepsis of the right knee joint/pyogenic arthritis of right knee joint (latency: 4 days).An aspiration of right knee was performed to check for any bacterial infection.The patient tolerated the procedure well.On (b)(6) 2017, patient reported for follow up of his right knee.The patient received his third dose of levaquin today.The same day, patient also had difficulty with ambulation to the point that he had to use crutches due to pain.Patient used tramadol when necessary.On (b)(6) 2017, lab test of the patient confirmed that he had septic right knee joint.The patient was instructed to continue with levaquin 250 mg iv daily for 14 days followed by 14 days of oral antibiotics.The same day, another aspiration of fluid from the right knee was performed to decrease inflammatory proteins.On (b)(6) 2017, patient reported for follow-up visit for evaluation of right septic knee joint.Patient underwent a re-aspiration of a possible septic right knee, this was the third aspiration.Every visit so far patient's symptoms are less with less fluid buildup and thus far serologies of the synovial fluid indicate decreasing white blood cell count.The patient was continued on ertapenem followed by 14 days of oral antibiotics and an aspiration of fluid from the right knee was performed to decrease inflammatory proteins.The patient tolerated the procedure well, was observed in the office and there were no complications.On (b)(6)2017, patient reported for follow up of possible septic right joint and underwent fourth aspiration.The culture was negative and no organisms were found.Patient did not have any symptoms of fever, no nausea, no diarrhea, no lymphangitis.On (b)(6) 2018, patient reported for reevaluation of his right knee and possible re-aspiration.Patient stated that his knee was pretty much back to baseline, no swelling but there is still some pain, patient denied any fevers, denied any lymphangitis, denied any erythema.Every visit so far patient's symptoms were less with less fluid buildup and thus far serologies of the synovial fluid indicate decreasing white blood cell count.It was patients 14th day of iv ertapenem and discussion with physician suggested patient move onto augmentin for another 14 days, patient to start augmentin 875 mg by mouth twice a day tomorrow.The same day, it concluded that so far all cultures were negative and white blood cell count had continued to be less than impressive for inflammatory secondary to infection.Since evaluation by infectious disease was still awaited, no aspiration was performed as so far there was no evidence of infection.On (b)(6) 2018, patient reported for follow up of rheumatological issues.Patient stated that these days, he hasn't had much pain in his knees and wondered if the injection was still working.Patient was a candidate for tka and was considering undergoing it around thanksgiving/christmas season when work is a little slower this year.On an unknown date, the patient reported not feeling good (latency: unknown), difficulty bending the knee (latency: unknown) and edema in right knee (latency: unknown).Action taken: not applicable corrective treatment: ice, rest and nabumetone, amoxcillin-clavunic acid(augmentin) and ertapenem, levaquin for sepsis of the right knee joint/pyogenic arthritis of right knee joint; crutches and tramadol for difficulty with ambulation; not reported for rest outcome: unknown for device malfunction, not feeling good, difficulty with ambulation; recovered/resolved for possible sepsis of the right knee joint/pyogenic arthritis of right knee join, difficulty bending the knee.A global pharmaceutical technical complaint was initiated with ptc number: 51425 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 (b)(6) 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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: disability for difficulty ambulation and device malfunction; medically significant and required intervention for sepsis of the right knee joint/pyogenic arthritis of right knee joint.Additional information was received on (b)(6) 2017 from the patient.The additional events of difficulty bending the knee, tenderness in the knee, knee swelling and fluid was removed from the knee were added with details.The suspect product start date was updated from (b)(6) 2017 to(b)(6) 2017.Clinical course updated.Information regarding past treatment with synvisc one was added.Text was amended accordingly.Additional information was received on (b)(6) 2018.The global ptc number was added.Text amended accordingly.Additional information was received on (b)(6) 2019 from lawyer.Event of sepsis of the right knee joint, difficulty with ambulation, edema in right knee added.Labs added.Medical history updated.Concomitant medications added.Clinical course was updated and text amended accordingly.Additional information received on (b)(6) 2019 from lawyer.Medical history of allergy to bactrim, allergy to clindamycin, allergy to keflex.Vaccination history of influenza.Concomitant medication of mobic, ambien and prilosec added.Event verbatim updated from sepsis of the right knee joint to possible sepsis of the right knee joint/pyogenic arthritis of right knee joint.Event outcome updated for tenderness in the knee/ right knee pain to recovering and swelling in right knee to recovered.Events of fluid was removed from the knee/ knee aspiration and swelling in right knee were updated to separate diagnosis.Clinical course updated.Text amended accordingly.
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