| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
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| Patient Problems
Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
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| Event Date 11/01/2017 |
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Event Type
Injury
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Event Description
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Difficulty bearing weight [weight bearing difficulty] , device malfunction [device malfunction] , difficulty bending [joint range of motion decreased] , difficulty moving [mobility decreased] , difficulty walking [difficulty in walking] , pain~/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain [knee pain] , swelling/knee swelling [swelling of knees] , fever [fever] , discomfort [discomfort] , reaction like he has never had before in these knees [local reaction] , weakness [weakness] , bruising [bruising].Case narrative: based on additional information received on 10-may-2018, this case initially considered as non-serious was upgraded to serious [required intervention for pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain].Additionally, this case became medically confirmed by physician.This spontaneous case from united states was received on 26-dec-2017 from the patient this case concerns a (b)(6) male patient who initiated treatment with synvisc one and after a few hours had swelling, pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain, difficulty bearing weight, difficulty moving, device malfunction and after 01 day experienced fever, discomfort, difficulty walking, difficulty bending and bruising, after few days had weakness, reaction like he has never had before in these knees medical history included (family history-hypertension, diabetes mellitus, arthritis), tonsillectomy (1979), ibd, apnea, headaches, heartburn, osteoarthritis and polycythemia.Patient was allergic to diphenhydramine hydrochloride (benadryl), naproxen sodium (aleve) and sulfa.Concomitant medication included lisinopril for high blood pressure, rosuvastatin calcium (crestor) and gemfibrozil for high cholesterol, dicycloverine (dicyclomine) and ibuprofen for pain, pravastatin sodium (pravastatin), tramadol hydrochloride (tramadol), gabapentin, tizanidine, orphenadrine citrate, fluticasone, clindamycin phosphate (clindamycin), cyanocobalamin (vitamin b12), rosuvastatin, hydrocortisone (proctosol), lansoprazole (prevacid), benzyl benzoate/bismuth hydroxide/bismuth subgallate/hydrocortisone acetate/myroxylon balsamum var.Pereirae balsam/resorcinol/zinc oxide (anusol-hc), testosterone (androgel), promiseb topical cream.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (lot details: 7rsl021; expiry date: not reported) for osteoarthritis.On the same day, the patient completed the treatment.On the same day patient had device malfunction.On an unknown date (b)(6) 2017, within 24 hours, he developed pain, swelling and difficulty moving or bearing weight.He states that both knees are affected but the right more than left.On (b)(6) 2017, 01 days after the event, the patient experienced fever, discomfort, severe right knee pain, difficulty walking, difficulty walking/bending and bruising.On unknown date of (b)(6) 2017 patient had weakness and reaction like he has never had before in these knees corrective treatment: ibuprofen, cortisone and cold pack for difficulty bending, difficulty moving, difficulty bearing weight, fever, discomfort, difficulty walking, pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain, swelling, difficulty bending and bruising; not reported for rest of the events.Outcome: recovering for fever, difficulty moving, difficulty bearing weight, pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain, swelling; not recovered for rest of the events; unknown for device malfunction, weakness, reaction like he has never had before in these knees.Seriousness criteria: required intervention for pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain.(b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional information was received on 09-feb-2018.The global ptc number and the results were added.Additional information was received on 20-feb-2018 from a patient.Event of discomfort, difficulty walking, difficulty bending and bruising were added with details.Therapy start date and indication were added.Concomitant medication, past drug, medical history and concurrent condition was added.Event start date was updated for fever.Corrective treatment for the event of fever, discomfort, difficulty walking, pain/severe right knee pain was added.Clinical course updated.Text amended accordingly.Additional information was received on 10-may-2018 from physician.This case initially considered as non-serious was upgraded to serious [required intervention for pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain].Additionally, this case became medically confirmed.Verbatim and seriousness updated for pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain.Events of device malfunction, weakness, reaction like he has never had before in these knees.Lot no.Added.Concomitant medications and medical history was added.Clinical course was updated and text was amended accordingly.
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Event Description
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Difficulty bearing weight [weight bearing difficulty] device malfunction [device malfunction] difficulty moving [mobility decreased] difficulty walking [difficulty in walking] difficulty bending [joint range of motion decreased] inflammatory reaction [inflammatory reaction] ([knee pain], [swelling of knees], [joint effusion], [fever]) discomfort [discomfort] reaction like he has never had before in these knees [local reaction] weakness [weakness] bruising [bruising] case narrative: based on additional information received on 10-may-2018, this case initially considered as non-serious was upgraded to serious [required intervention for pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain].Additionally, this case became medically confirmed by physician.This spontaneous case from united states was received on 26-dec-2017 from the patient this case concerns a 44 year old male patient (185.42 cm and 175 kg) who initiated treatment with synvisc one and after a few hours had difficulty bearing weight, difficulty moving, device malfunction and after 01 day experienced discomfort, difficulty walking, difficulty bending and bruising, after few days had weakness, reaction like he has never had before in these knees, after an unknown latency had inflammatory reaction.A device malfunction was also noted for the reported batch number.The patient's past medical history included osteoarthritis, polycythaemia, drug hypersensitivity with benadryl, sulfa and aleve, dyspepsia, headache, sleep apnoea syndrome, tonsillectomy in 1979, musculoskeletal pain, clavicle fracture in 1989, back pain, nausea, vomiting, joint stiffness, arthralgia, cervical spinal stenosis, spinal flattening, spinal cord disorder, hypertension, diabetes mellitus, joint noise, joint range of motion decreased, joint range of motion decreased, crohn's disease, pain in extremity, tendonitis, fibromatosis, epidural injection on 22-nov-2016 and on 8-dec-2016, neck pain, kyphosis and spinal osteoarthritis.The patient's past medical treatment included benadryl and naproxen sodium.The patient's family history included diabetes mellitus with mother, depression with mother, hypertension with mother, arthritis with family, neoplasm malignant with family and cerebrovascular accident with family.The patient's past vaccination(s) was not provided.At the time of the event, the patient had ongoing irritable bowel syndrome, hypertension, blood cholesterol increased and pain.On 17-nov-2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (lot details: 7rsl021; expiry date: not reported) for osteoarthritis.On the same day, the patient completed the treatment.On the same day patient had device malfunction.On an unknown date nov-2017, within 24 hours, he developed pain, swelling and difficulty moving or bearing weight.He states that both knees are affected but the right more than left.On 18-nov-2017, 01 days after the event, the patient experienced fever, discomfort, severe right knee pain, difficulty walking, difficulty walking/bending and bruising.On unknown date of nov-2017 patient had weakness and reaction like he has never had before in these knees.On an unknown date after an unknown latency patient had an inflammatory reaction related to synvisc one.On 27-dec-2018, patient ad his knee aspirated and injected with betamethasone acetate 3 mg and betamethasone phosphate 3 mg.On 02-jul-2018, patient received monovisc injection in both knees.Corrective treatment: ibuprofen, cortisone and cold pack for difficulty bending, difficulty moving, difficulty bearing weight, discomfort, difficulty walking, difficulty bending and bruising; ibuprofen, cortisone and cold pack, tramadol, betamethasone acetate 3 mg and betamethasone phosphate 3 mg for inflammatory reaction; not reported for rest of the events outcome: recovering for difficulty moving, difficulty bearing weight; not recovered for rest of the events; unknown for device malfunction, weakness, reaction like he has never had before in these knees seriousness criteria: required intervention for inflammatory reaction, difficulty bearing weight, device malfunction, difficulty bending, difficulty moving, difficulty walking a pharmaceutical technical complaint (ptc) was initiated with the global ptc number: 51610.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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional information was received on 09-feb-2018.The global ptc number and the results were added.Additional information was received on 20-feb-2018 from a patient.Event of discomfort, difficulty walking, difficulty bending and bruising were added with details.Therapy start date and indication were added.Concomitant medication, past drug, medical history and concurrent condition was added.Event start date was updated for fever.Corrective treatment for the event of fever, discomfort, difficulty walking, pain/severe right knee pain was added.Clinical course updated.Text amended accordingly.Additional information was received on 10-may-2018 from physician.This case initially considered as non-serious was upgraded to serious [required intervention for pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain].Additionally, this case became medically confirmed.Verbatim and seriousness updated for pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain.Events of device malfunction, weakness, reaction like he has never had before in these knees.Lot no.Added.Concomitant medications and medical history was added.Clinical course was updated and text was amended accordingly.Additional information was received on 28-nov-2018 from physician.Medical history was added.Event of inflammatory reaction was added.Events of pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain, swelling/knee swelling and fever were updated as symptoms of inflammatory reaction.Investigation summary was updated as per reported batch lot number.Clinical course was updated and text was amended accordingly.
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