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 Pain (1994); Loss of Range of Motion (2032); Joint Swelling (2356); Ambulation Difficulties (2544)

Event Date 11/06/2017

Event Type  Injury  

Event Description

(b)(4).This unsolicited case was received from united states on 28-feb-2018 from a patient.This case involves a (b)(6) female patient who received treatment with synvisc one and after unknown latency was having difficulty bearing full weight when bending the knee and aspirated the right knee and after few hours the right knee was severely painful and swollen.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 1 df once (route, batch/ lot number: 7rsl021; and expiration date: unknown) (indication: not provided).On the same day, few years after the first injection, the patient's right knee was severely painful and swollen.On an unknown date in (b)(6) 2017, after unknown latency, the patient was having difficulty bearing full weight when bending the knee for two days and doctor aspirated the right knee.Action taken: no action taken.Corrective treatment: not reported for all the events.Outcome: unknown for all the events.Seriousness criteria: important medical event for device malfunction.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.Pharmacovigilance comment: sanofi company comment dated 06-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced the right knee pain, swelling and weight bearing difficulty.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: 7334133
• MDR Text Key: 102315355
• Report Number: 2246315-2018-00386
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/28/2018

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 Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/13/2018
• 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: 54 YR