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

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

Patient Problems Inflammation (1932); Joint Disorder (2373)

Event Date 04/29/2004

Event Type  Injury  

Event Description

Acute inflammatory knee effusion [injection site joint inflammation] ([injection site joint effusion]).Case narrative: initial information was received on (b)(6) 2020 regarding an unsolicited valid serious case from a physician via health authorities of united states under reference mw5097798.This case involves a patient (with unknown demographics) who experienced acute inflammatory knee effusion, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On an unknown date in 2004, the patient received third injection of synvisc (hylan g-f 20, sodium hyaluronate) via intra-articular route in knee (unspecified) (dose, frequency, indication and lot - unknown).There would be no information available on the batch number of this case.On (b)(6) 2004, after unknown latency following 3rd injection of synvisc in knee, the patient had an acute inflammatory knee effusion (injection site joint inflammation and injection site joint effusion).This event was leading to intervention (not specified).Final diagnosis was acute inflammatory knee effusion.Action taken: not applicable.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for acute inflammatory knee effusion a product technical complaint (ptc) was initiated on 14-dec-2020 for synvisc, batch number: unknown; 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 (corrective and preventive action) 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 (non-conformance) process.Sanofi global pharmacovigilance and epidemiology would continuously monitor 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 had not indicated any safety issue.Sanofi will continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to determine if a capa was required.Final investigation was completed on (b)(6) 2020.Additional information was received on 23-dec-2020 from other healthcare professional: ptc results were received and added to the case.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: 11086258
• MDR Text Key: 229909091
• Report Number: 2246315-2020-00185
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Required Intervention