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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Event Description

Significant pain [pain], device malfunction [device malfunction], trouble walking [difficulty in walking].Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request this unsolicited case was received from united states on 27-feb-2018 from other non-healthcare professional via health authority: usa-fda.This case involves a female patient of unknown age who received treatment with synvisc one and had significant pain, trouble walking (both after unknown latency).Also, device malfunction was identified for the reported lot number.No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported.On unknown date, patient started treatment with intra-articular synvisc one injection (dose, frequency, indication: not reported; batch/lot number: 7rsl021; expiry date: not reported).On unknown dates, after unknown latencies, she had significant pain and trouble walking for several days post injection.Event abated after dose stopped or dose reduced.Action taken: unknown.Corrective treatment: not reported for all the events.Outcome: recovering/resolving for all the 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 criteria: medically significant for significant pain, trouble walking, device malfunction.Pharmacovigilance comments: sanofi follow-up company comment dated: 07-mar2018: this case concerns a patient who received treatment with synvisc one and later had significant pain and trouble walking.Since the events occured after synvic injection from recalled lot, the causal role of the device cannot be denied for the occurrence of event.Further, as the concerned lot number has been identified to have device malfunction the causal role in the occurence of the events 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: 10453916
• MDR Text Key: 213415311
• Report Number: 2246315-2020-00121
• 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: No Information
• 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; Required Intervention