Lot Number CRSP002 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Synovitis (2094)
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment dated 22-jul-2022: this case involves a 61 years old male patient who had chronic synovitis on gonarthrosis, knee hurts and water in the knee while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The causal role of drug cannot be excluded for the event.However, lack of information regarding event details, patient's compliance, treatment received, lab data and concomitant medications precludes the comprehensive assessment of the case.
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Event Description
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Chronic synovitis on gonarthrosis (right knee) [synovitis chronic] ([effusion (r) knee], [knee pain]).Case narrative: this case is linked to case (b)(4) (multiple devices).Initial information was received on 05-jul-2022 regarding a solicited valid serious case from a consumer/non-hcp, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: (b)(6); country: canada.Study title: patient support program involving synvisc.This case involves a 61 years old male patient who had chronic synovitis on gonarthrosis (right knee) with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.The patient had ongoing gonarthrosis with presence of calcium pyrophosphate.Concomitant medication included triamcinolone acetonide (kenalog).On (b)(6) 2022, the patient started receiving synvisc (hylan g-f 20, sodium hyaluronate, 16 mg/2ml) injection at dose of 2 ml 3x as lateral injection in stretched/extended right knee (lot - crsp002, unknown expiry date, strength) for osteoarthritis grade ii.Last injection was on (b)(6) 2022.Since an unknown date, after unknown latency, he occasionally got a little water in his knees, especially in his left knee (joint effusion, mild, intervention required).When the patient went to the physician on tuesday, (b)(6) 2022, he received synvisc injections in his right knee.Also, on (b)(6) 2022, doctor gave 21 ml citrin by puncture in knee (not specified) and on (b)(6) 2022, gave 20 mg kenolog, puncture 7ml citrin and synvisc 6 ml.He did not know when he got the water only knew that his knee hurt (arthralgia, mild, intervention required).It was unknown if the patient experienced any additional symptoms/events.It is unknown if there were lab data/results available.Upon follow up, hcp confirmed that he patient had water in knees due to chronic synovitis on gonarthrosis (synovitis, intervention required, mild).The treatment with synvisc had not contributed to the reported events and the reported events were due to the pre-existing condition of gonarthrosis with presence of calcium pyrophosphate.Medical management of events was done with corticosteroids puncture.This was not an adverse effect of synvisc.Action taken: not applicable.Corrective treatment: corticosteroids puncture.At time of reporting, the outcome was recovering.Reporter causality: not related.Company causality: not reportable.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 06-jul-2022 for synvisc.Batch number: crsp002 and results were pending for the same.Additional information was received on 22-jul-2022 from other healthcare professional.This case previously assessed as non-serious was upgraded to serious because the patient had received corticosteroids puncture for management of reported events.Case became medically confirmed.Event added- chronic synovitis on gonarthrosis.Events- occasionally got a little water in his knees (right knee) and knee hurt (right knee) were considered as symptoms of synovitis; their outcome, intensity, reporter causality was updated.Strength and global ptc number was added.Clinical course was updated.Text was amended accordingly.
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Event Description
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Chronic synovitis on gonarthrosis (right knee) [synovitis chronic] ([effusion (r) knee], [knee pain]).Case narrative: this case is linked to case (b)(4) (multiple devices).Initial information was received on 05-jul-2022 regarding a solicited valid serious case from a consumer/non-hcp(non health care professional), in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: (b)(6).Study title: patient support program involving synvisc.This case involves a 61 years old male patient who had chronic synovitis on gonarthrosis (right knee) with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.The patient had ongoing gonarthrosis with presence of calcium pyrophosphate.Concomitant medication included triamcinolone acetonide (kenalog).On (b)(6) 2022, the patient started receiving synvisc (hylan g-f 20, sodium hyaluronate) injection at dose of 2 ml 3x(thrice) as lateral injection in stretched/extended right knee having the strength 16mg/2ml (lot - crsp002, expiry date: 31-dec-2024) for osteoarthritis grade ii.Last injection was on (b)(6) 2022.Since an unknown date, after unknown latency, he occasionally got a little water in his knees, especially in his left knee (joint effusion, mild, intervention required).When the patient went to the physician on tuesday, (b)(6) 2022, he received synvisc injections in his right knee.Also, on (b)(6) 2022, doctor gave 21 ml citrin by puncture in knee (not specified) and on (b)(6) 2022, gave 20 mg kenolog, puncture 7ml citrin and synvisc 6 ml.He did not know when he got the water only knew that his knee hurt (arthralgia, mild, intervention required).It was unknown if the patient experienced any additional symptoms/events.It is unknown if there were lab data/results available.Upon follow up, hcp(health care professional) confirmed that he patient had water in knees due to chronic synovitis on gonarthrosis (synovitis, intervention required, mild).The treatment with synvisc had not contributed to the reported events and the reported events were due to the pre-existing condition of gonarthrosis with presence of calcium pyrophosphate.Medical management of events was done with corticosteroids puncture.This was not an adverse effect of synvisc.Action taken: not applicable.Corrective treatment: corticosteroids puncture.At time of reporting, the outcome was recovering.A product technical complaint (ptc) was initiated on 06-jul-2022 for synvisc (lot/batch number: crsp002) with global ptc number: (b)(4).The sample status of the ptc(product technical complaint) was not received and the ptc stated: the production and quality control documentation for lot # crsp002 expiration date (2024-12) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # crsp002 no capa(corrective and preventive action) was required.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.As of 8sep22 there are 3 complaints on file for lot# crsp002 and all related sublots.3 complaints are on file for lot#crsp002a: (3) adverse event reports.Sanofi will continue to monitor complaints to determine if a capa(corrective and preventive action) was required.The final investigation was completed on 08-sep-2022 with summarized conclusion as no assessment possible.Reporter causality: not related.Company causality: not reportable.Additional information was received on 22-jul-2022 from other healthcare professional.This case previously assessed as non-serious was upgraded to serious because the patient had received corticosteroids puncture for management of reported events.Case became medically confirmed.Event added- chronic synovitis on gonarthrosis.Events- occasionally got a little water in his knees (right knee) and knee hurt (right knee) were considered as symptoms of synovitis; their outcome, intensity, reporter causality was updated.Strength and global ptc number was added.Clinical course was updated.Text was amended accordingly.Additional information was received on 08-sep-2022 from the quality department.Ptc details was added.Text amended accordingly.
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