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

Lot Number UNKNOWN

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 (left knee) [unspecified disorder of knee joint].Case narrative: the case is linked to (b)(4) (multiple device; right knee).Initial information from united states received on 06-may-2021 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 (left knee) 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 weekly, sodium hyaluronate (strength: 16 mg) (dose, route, batch number unknown) for osteoarthritis knee pain about 3 or 4 times, in left 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 left knee to deteriorate (arthropathy), so that approximately 3 years ago (2018) he had total knee replacement in his left knee.Patient stated that his left knee was now fine, he would not even know that he had a total knee replacement in that knee.Action taken: not applicable.Corrective treatment: total knee replacement for arthropathy.At time of reporting, the outcome was not recovered / not resolved.Seriousness criteria: intervention required.

Event Description

Wear and tear on his knee joints causes his knees to deteriorate (left knee) [unspecified disorder of knee joint].Case narrative: initial information from united states received on 06-may-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp.The case is linked to (b)(4) (multiple device used in same patient; right knee).This case involves an adult male patient who experienced wear and tear on his knee joints causes his knees to deteriorate (left knee) 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 weekly (strength: 16 mg/2ml) (dose, route, batch number unknown) for osteoarthritis knee pain about 3 or 4 times, in left 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 left knee to deteriorate (arthropathy), so that approximately 3 years ago (2018) he had total knee replacement in his left knee.Patient stated that his left knee was now fine, he would not even know that he had a total knee replacement in that knee.Action taken: not applicable.Corrective treatment: total knee replacement for arthropathy.At time of reporting, the outcome was not recovered / not resolved.Seriousness criteria: intervention required.A product technical complaint (ptc) was initiated on 06-may-2021 for synvisc (hylan g-f 20, sodium hyaluronate) (batch number: unknown) with global ptc number: (b)(4).The sample was not available and ptc was set in process.Additional information was received on 06-may-2021 from quality department: ptc details with global ptc number added.Text was amended accordingly.

Event Description

Wear and tear on his knee joints causes his knees to deteriorate (left knee) [unspecified disorder of knee joint] case narrative: initial information from united states received on (b)(6)2021 regarding an unsolicited valid serious case received from a patient.The case is linked to (b)(4) (multiple devices suspect for same patient; right knee).This case involves an adult male patient who experienced wear and tear on his knee joints causes his knees to deteriorate (left knee) while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant medications, 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 weekly (strength: 16 mg/2ml; liquid solution) (dose, route, batch number and expiry date: unknown) for osteoarthritis knee pain about 3 or 4 times, in left knee, over the course of several years.There will be no information available on batch number of this case (product had been discarded and batch number unknown) it was reported that hylan g-f 20, sodium hyaluronate worked well for his osteoarthritis knee pain, but over the time since unknown date, after unknown latency, the wear and tear on his knee joints caused his left knee to deteriorate (arthropathy), so that approximately 3 years ago (2018) he had total knee replacement in both knees and would like to know if he could use synvisc again.Patient stated that his left knee was now fine, he would not even know that he had a total knee replacement in that knee.Action taken: not applicable corrective treatment: total knee replacement for arthropathy at time of reporting, the outcome was not recovered / not resolved seriousness criteria: intervention required.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc (hylan g-f 20, sodium hyaluronate) (batch number and expiry date: unknown) with global ptc number: (b)(4).The sample of the ptc (product technical complaint) was not available.Ptc stated: preliminary assessment: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction, a death or serious injury.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.The defect class has been updated to ii ((b)(6) 2023).Investigation: ((b)(6) 2023): the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) was required.The final investigation was completed on (b)(6) 2023 and the summarized conclusion was "no assessment possible." additional information was received on (b)(6) 2021 from quality department: ptc details with global ptc number added.Text was amended accordingly.Additional information was received on (b)(6) 2023 from healthcare professional via quality department.Ptc investigation results added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 11820571
• MDR Text Key: 265499433
• Report Number: 2246315-2021-00105
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male