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 11/09/2017

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment follow up dated 21-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced swelling and pain.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.

Event Description

Device malfunction [device malfunction], swelling [injection site swelling], pain [injection site pain].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 non-healthcare professional via fda (food and drug administration) (regulatory number: mw5075448).This case concerns a patient (demographics not provided) who experienced swelling and pain after unknown latency 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, the patient initiated treatment with intra-articular synvisc one injection 6 ml (48 units) once (batch/lot number: 7rsl021, expiry date: 31-may-2020) for right knee pain in right knee.On (b)(6) 2017 after unknown latency, the patient experienced swelling and pain 5xs, as a result of injection.Corrective treatment: not reported for swelling and pain.Outcome: recovered 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 follow up dated 21-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced swelling and pain.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.

• 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: 7404154
• MDR Text Key: 213407246
• Report Number: 2246315-2018-00426
• 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

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• 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