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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problem Swelling (2091)

Event Date 06/01/2017

Event Type  Injury  

Event Description

Device malfunction; swelling of right knee.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 08-feb-2018 from a pharmacist via food and drug administration (regulatory number: mw5073921).This case concerns a patient (demographics not provided) who experienced swelling of right knee after 01 day of 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 jun-2017, the patient initiated treatment with intra-articular synvisc one injection 6 ml once (batch/lot number: 7rsl021, expiry date: not provided) for osteoarthritis of right knee in both knees.On an unspecified date in jun-2017 (01 day after first dose of synvisc one), the patient complained of concern of significant swelling of right knee.Corrective treatment: not reported for swelling of right knee.Outcome: unknown for swelling of right knee.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 both events.Pharmacovigilance comment: sanofi company comment dated: 22-feb-2018: this case concerns a male patient who received treatment with synvisc one and later had numbness in the knee, difficulty in straightening the knee and feeling hot.Based upon the company investigation, the causal role of the product cannot be denied with the occurrence of event.Further information regarding patient's current clinical presentation, medical history, concomitant medications, and other risk factors would aid in the complete medical assessment of the 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: 7298894
• MDR Text Key: 212513294
• Report Number: 2246315-2018-00344
• 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
• Reporter Occupation: Pharmacist
• 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?: No
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2018
• 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