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); No Code Available (3191)

Event Date 11/08/2017

Event Type  malfunction  

Event Description

(b)(4).This unsolicited case from united states was received on 27-feb-2018 from a patient.This case involves a (b)(6) female patient who received treatment with synvisc one and the same day had knee effusion aspiration, knee joint effusion and knee pain.Also, device malfunction was identified for the reported lot number.No past drugs, medical history, concomitant medication or concurrent condition was reported.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (route, batch/ lot number: 7rsl021and expiration date: may-2020) for knee osteoarthritis.On the same day, the patient had knee joint effusion and pain and the fluid was sent for analysis.Corrective treatment: steroid, knee effusion aspiration for knee joint effusion; steroid for knee pain.Outcome: recovered 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 this investigation is completed, corrective and preventive actions would be implemented.Seriousness criteria: required intervention for all the events.Pharmacovigilance comment: sanofi company comment dated 07-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced knee pain and knee effusion.A temporal relationship can be established with the product administration.In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product 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: 7334208
• MDR Text Key: 102750296
• Report Number: 2246315-2018-00387
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 86