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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Date 01/01/2014

Event Type  Injury  

Event Description

This unsolicited device case from (b)(6) was received on (b)(6) 2015 from an orthopedist.This case involves a (b)(6) female patient who received treatment with synvisc and experienced osteonecrosis of the medial condyle of the femur.The patient's medical history, concomitant medications or concurrent conditions were not reported.It was reported that the patient received treatment with hyaluronate sodium (artz) at an unspecified dose for osteoarthritis (oa) three times, and then the medication was switched from hyaluronate sodium (artz) to synvisc.On an unknown date in 2014 (in the fall), the patient initiated treatment with intra-articular synvisc 2 ml injection (frequency, dose, batch/lot number and expiry date was not provided) for osteoarthritis.In the fall of 2014, after unknown latency, at the time of the second dose of synvisc, the reporting orthopedist received the impression that the medial condyle of the femur was low only a little.It was reported that just to be safe, synvisc was discontinued.Action taken; drug withdrawn nos.

Manufacturer Narrative

Corrective treatment: not reported.Outcome: unknown.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same seriousness criteria: important medical event.Reporting orthopedist's causality assessment: unknown.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2015: this case concerns a (b)(6) female patient who received treatment with synvisc and later experienced osteonecrosis.The role of drug in the occurrence of event cannot be denied with synvisc and later experienced osteonecrosis.The role of drug in the occurrence of event cannot be denied as they occurred in a close proximal relationship with the administration of drug.However, lack of detailed information about medical history, concurrent conditions and concomitant medication precludes a comprehensive assessment in this case.

• Brand Name: SYNVISC (SYNVISC)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corporate drive; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4660244
• MDR Text Key: 20371713
• Report Number: 2246315-2015-40702
• 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: Foreign,Health Professional
• Type of Report: Initial
• Report Date: 03/27/2015

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: Health Professional
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/02/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARTZ (PREV)
• Patient Outcome(s): Other
• Patient Age: 60 YR