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].Severe pain [knee pain.] stiffness [joint stiffness].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 healthcare professional via fda (food and drug administration) (regulatory number: mw5075406).This case concerns a patient (demographics not provided) who experienced severe pain, stiffness and swelling few hours after receiving treatment with synvisc one.Also device malfunction was identified for the reported lot number.No relevant medical history, past drugs, concomitant medication or concurrent condition was provided.On an unspecified date in 2017, the patient initiated treatment with intra-articular synvisc one injection 6 ml once (batch/lot number: 7rsl021, expiry date: unknown) was injected into both knees for degenerative joint disease.The same day within 4 hours, the patient had severe pain, stiffness, swelling.Corrective treatment: not reported for severe pain, stiffness and swelling 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: medically significant for all events.Pharmacovigilance comment: sanofi company comment dated 29-mar-2018.This case concerns a patient who received treatment with synvisc one injection from recall lot and later experienced pain, stiffness and swelling.Since events occurred few hours after administration of synvisc one injection, significant temporal relationship can be established.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: 10453927
• MDR Text Key: 213247062
• Report Number: 2246315-2020-00116
• 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 Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• 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