MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Arthralgia (2355); Joint Swelling (2356)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 21-mar-2018 from the other health care professional.This case involves a patient (unknown gender) who received treatment with synvisc one and after few hours the patient had severe pain, swelling and device malfunction was identified for the reported lot number.No medical history, past drugs, concomitant medications, concurrent condition was provided.On unknown date of (b)(6) 2017, the patient initiated treatment with injection of synvisc one, intraarticular at a dose of 6 ml (frequency: once; lot number: 7rsl021) for unilateral primary osteoarthritis.On (b)(6) 2017, after few hours the patient had severe pain, swelling.Corrective treatment: not reported.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 is completed, corrective and preventive actions would be implemented.Seriousness criteria: medically significant.Pharmacovigilance comment: sanofi company comment dated 21-march-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced knee pain and knee swelling.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: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7402621
• MDR Text Key: 105265557
• Report Number: 2246315-2018-00432
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• 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: 03/21/2018

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 Operator: Other
• Device Lot Number: 7RSL021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other