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

Lot Number UNKNOWN

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

Patient Problems Synovitis (2094); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/06/1998

Event Type  Injury  

Event Description

Synovitis [synovitis] acute, inflammatory arthritis left knee [inflammatory arthritis].Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5097847 via physician.This case involves adult patient who experienced acute inflammatory arthritis left knee and synovitis, 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.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate at a dose of 2 ml (frequency: unknown) via intra-articular route (lot - unknown) for unknown indication.On (b)(6) 1998 after an unknown latency patient developed an event of a serious acute inflammatory arthritis left knee (arthritis).This event was leading to disability.Synovial culture came out negative ruling out infection as cause of synovitis.This event was leading to disability.Action taken: not applicable for both events final diagnosis was acute inflammatory arthritis left knee.It was not reported if the patient received a corrective treatment.The patient outcome is reported as not recovered / not resolved for both events a product technical complaint (ptc) was initiated on 09-nov-2020 for synvisc.Batch number: unknown; comet (expanded form not specified) compliant id number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventative actions) was required.It was 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 (expanded form not specified) 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.Final investigation complete date was 21-may-2021.No safety issues were indicated in this review.Follow up information was received on 09-jan-2021 from healthcare professional.Global ptc number was added.Text amended accordingly.Additional information was received on 21-may-2021 from the healthcare professional.Ptc results were 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: 11893099
• MDR Text Key: 266279595
• Report Number: 2246315-2021-00107
• 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: health professional
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2021
• 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): Disability