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); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Device malfunction [device malfunction].Unable to fully bear weight on knees [weight bearing difficulty].Knee pain [knee pain].Knee swelling [knee 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 21-mar-2018 from a nurse via health authority (usafda: food and drug administration; reference number: mw5075402) this case involves a male patient (age not provided) who received treatment with synvisc one and after unknown latency was unable to fully bear weight on knees, knee pain, knee swelling.Also, device malfunction was identified for the reported lot number.No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported.On an unknow date in 2017, the patient receive treatment with intra-articular synvisc one, injection (batch/lot number: 7rsl021; expiration date: 31-may-2020; dose not provided) for osteoarthritis of bilateral knees.On an unknown date, after unknown latency, at 2 am, the patient woke up with severe bilateral knee pain and swelling.The patient reported that he was unable to fully bear weight on his knees(onset date: 2017; latency: unknown).Corrective treatment: not reported for all the events.Outcome: unknown for all the events.Seriousness criteria: medically significant for all the events.A product technical complaint was initiated with following results: 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.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later had pain in both knees, knee swelling, and weight bearing difficulty.A temporal relationship cannot be established with the product administration, but since 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.Further information regarding complete medical history, any concomitant or past medications and any concurrent medical conditions will aid in comprehensive assessment of this case.

• 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: 10453919
• MDR Text Key: 213231588
• Report Number: 2246315-2020-00105
• 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
• 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 Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• 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