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 Fever (1858); Synovitis (2094); Arthralgia (2355)

Event Date 01/01/1998

Event Type  Injury  

Event Description

Proliferative synvitis [synovitis of knee] ([aching (r) knee], [fever]).Case narrative: initial information received on 14-dec-2020 regarding an unsolicited valid serious case received from health care professional via health authorities of united states under reference mw5097870.This case involves an unknown age patient who had proliferative synovitis, while he/she was 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.Concomitant medications included oxycodone hydrochloride, paracetamol (percocet); doxazosin mesilate (cardura); guanfacine hydrochloride (tenex); nifedipine (procardia); atenolol; and calcium acetate (phoslo).On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection via intra-articular route in right knee (unknown dose, frequency, batch number) for unknown indication.On (b)(6) 1998, eighth day after last injection, the patient developed a serious acute knee pain, fever and was hospitalized for the same (latency: few days).The culture of synovial fluid showed no organisms or crystals and eventually went for synovial biopsy which showed proliferative synovitis (synovitis; onset date: 1998 and latency: few days).Action taken: unknown.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown.A product technical complaint (ptc) was initiated on 14-dec-2020 for synvisc for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.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 (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 23-dec-2020.Additional information was received on 23-dec-2020 from healthcare professional.Investigational 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: 11094292
• MDR Text Key: 231196651
• Report Number: 2246315-2020-00191
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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
• 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): Hospitalization; Required Intervention