MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Wear and tear on his knee joints causes his knees to deteriorate (right knee) [unspecified disorder of knee joint].Right knee drained of fluid [effusion (r) knee] ([aching (r) knee], [swelling of r knee]).Case narrative: initial information received on 06-may-2021 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves an unknown age male patient who experienced wear and tear on his knee joints causes his knees to deteriorate (right knee) and right knee drained of fluid while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, patient started treatment with three-injection series of hylan g-f 20, sodium hyaluronate (strength: 16 mg) (dose, frequency, route, batch number unknown) for osteoarthritis knee pain about 3 or 4 times, in right knee, over the course of several years.It was reported that hylan g-f 20, sodium hyaluronate worked well, but over the time since unknown date, after unknown latency, the wear and tear on his knee joints caused his right knee to deteriorate (arthropathy), so that approximately 3 years ago (2018) he had total knee replacement in his right knee.Since unknown date, after total knee replacement in right knee, after unknown latency, patient was experiencing pain and swelling in his right knee (arthralgia, joint swelling).Patient stated that he had to have his right knee drained of fluid (joint effusion) (onset and latency unknown).Patient further stated that they had done blood tests, and determined there was no infection in his right knee.Patient was told by healthcare provider that for some reason his body might just not be accepting the right total knee replacement.Action taken: not applicable for all events.Corrective treatment: total knee replacement for arthropathy; not reported for other event.At time of reporting, the outcome was not recovered / not resolved for all events.Seriousness criteria: intervention required for all events.

Event Description

Wear and tear on his knee joints causes his knees to deteriorate (right knee) [unspecified disorder of knee joint] right knee drained of fluid [effusion (r) knee] ([aching (r) knee], [swelling of r knee]) case narrative: initial information received on (b)(6) 2021 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves an unknown age male patient who experienced wear and tear on his knee joints causes his knees to deteriorate (right knee) and right knee drained of fluid while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, patient started treatment with three-injection series of hylan g-f 20, sodium hyaluronate (strength: 16 mg) (dose, frequency, route, batch number unknown) for osteoarthritis knee pain about 3 or 4 times, in right knee, over the course of several years.It was reported that hylan g-f 20, sodium hyaluronate worked well, but over the time since unknown date, after unknown latency, the wear and tear on his knee joints caused his right knee to deteriorate (arthropathy), so that approximately 3 years ago (2018) he had total knee replacement in his right knee.Since unknown date, after total knee replacement in right knee, after unknown latency, patient was experiencing pain and swelling in his right knee (arthralgia, joint swelling).Patient stated that he had to have his right knee drained of fluid (joint effusion) (onset and latency unknown).Patient further stated that they had done blood tests, and determined there was no infection in his right knee.Patient was told by healthcare provider that for some reason his body might just not be accepting the right total knee replacement.Action taken: not applicable for all events corrective treatment: total knee replacement for arthropathy; not reported for other event at time of reporting, the outcome was not recovered / not resolved for all events a product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc, batch number: unknown with global ptc number: 100124111.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.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Final investigation was completed on (b)(6) 2021 seriousness criteria: intervention required for all events follow up information was received on (b)(6) 2021 from other healthcare professional.Global ptc number was added.No significant information was received.Additional information was received on (b)(6) 2021 from other healthcare professional.Ptc results were added.Text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11811812
• MDR Text Key: 264825712
• Report Number: 2246315-2021-00102
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention