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 Problem Pain (1994)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on (b)(6) 2018 from a patient's daughter.This case concerns a (b)(6) female patient who received treatment with synvisc one and on the same day pain came with injection.Also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with single intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number: 7rsl021; expiry date: unknown) for left knee osteoarthritis.On the same day after the injection, patient did have some pain which the doctor told that came with the injection at first other than that patient was okay.It was reported that this was patient first time has received a synvisc-one injection.Patient was using it trying to avoid knee surgery.Patient walked two miles a day.It was reported that patient does not experience any adverse effect from receiving the recalled lot in her left knee.Patient has been walking a little less lately after the shot, but still walked at least a mile.Patient does not walk as much when it was cold outside.Corrective treatment: not reported outcome: recovered 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 criterion: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 01-feb-2018: this case concerns a female patient who received synvisc one injection from the recalled lot and pain came with injection.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: 7265957
• MDR Text Key: 100269139
• Report Number: 2246315-2018-00260
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 01/25/2018
• 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): Other
• Patient Age: 82 YR