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 11/30/2017

Event Type  Injury  

Event Description

Device malfunction [device malfunction].Had a lot of swelling [joint swelling].Had intense pain [arthralgia].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 (mw5074668).This case involves a male patient of unknown age who received treatment with synvisc one and had a lot of swelling and had intense pain (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 received treatment with intra-articular synvisc one injection (dose, frequency, indication: not reported; lot/batch number: 7rsl021; expiry date: unknown).On (b)(6) 2017, after unknown latency, patient had a lot of swelling and intense pain for about 2 weeks after injection.Patient had synvisc- one injection from lot that was later discovered to be recalled.Corrective treatment: not reported for all the events outcome: unknown 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 the investigation is completed, corrective and preventive actions would be implemented.Seriousness criteria: medically significant for all the events pharmacovigilance comment: sanofi company comment dated 08-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced knee swelling and knee pain.A temporal relationship can be established with the product administration.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: 7334362
• MDR Text Key: 213489277
• Report Number: 2246315-2018-00393
• 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
• Reporter Occupation: Other
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2018
• 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; Other
• Patient Sex: Male