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 Arthralgia (2355); Joint Swelling (2356)

Event Date 11/03/2020

Event Type  Injury  

Event Description

Knees swelled and became incredibly painful [knee pain].Knees swelled and became incredibly painful [knee swelling].Case narrative: this case was cross linked with the case (b)(4) (multiple device, same patient).Initial information from received on 08-jan-2021 regarding an unsolicited valid serious case received from the patient via health authorities of united states under reference number mw5097697.This case involves an adult female patient whose knees swelled and became incredibly painful, 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 received second injection of the series of hylan g-f 20, sodium hyaluronate injection (3x2ml) via intra-articular route (lot, indication, dose and frequency: unknown).On (b)(6) 2020, after a latency of few days patient reported that her knees swelled and became incredibly painful (arthralgia and joint swelling).The events were considered to cause serious injury (medically significant).Action taken: no action taken for both events.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for both events.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc, batch number: unknown with global ptc 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 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 22-jan-2021.Additional information was received on 08-jan-2021 from other healthcare professional.Gptc number was added.Additional information was received on 22-jan-2021 from other health care professional.Ptc results were added.

• 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: 11257041
• MDR Text Key: 229576516
• Report Number: 2246315-2021-00051
• 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: 02/01/2021

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: 02/01/2021
• 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): Other; Required Intervention