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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Arthralgia (2355); Joint Swelling (2356)

Event Date 12/06/2017

Event Type  malfunction  

Event Description

Device malfunction.Extreme pain/ tenderness, knee pain, joint swelling.Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request.This unsolicited case from united states was received on (b)(6) 2018 from other non-healthcare professional via health authority (usa-fda: food and drug administration: mw5074666).This case concerns a patient (demographics unspecified) who received treatment with synvisc one and after unknown latency had extreme pain/tenderness and swelling.Also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication or concurrent condition was provided.On an unknown date in 2017, the patient initiated treatment with intra-articular synvisc one injection, one dosage form once (batch/lot number: 7rsl021.Bilateral injections into knees.On (b)(6) 2017, after unknown latency, post injection, patient experienced extreme pain, swelling and tenderness.Corrective treatment: not reported for both events.Outcome: unknown for all events.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criterion: medically significant for all events.Additional information was received on 08-mar-2018.Global ptc number was added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 8-mar-2018: this case concerns a patient who had received synvisc one injection from the recalled lot and later had knee pain and swelling and tenderness.Since the events occurred after receiving the suspect, the causality of the event with suspect cannot be denied.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.

• Brand Name: SYNVISC ONE
• 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: 10453926
• MDR Text Key: 204876158
• Report Number: 2246315-2020-00103
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• 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): Other