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

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 09/01/2014

Event Type  No Answer Provided  

Event Description

This unsolicited device case from united states was received on 04/15/2015 from a pt.This case involved a (b)(6) female pt who broke 3 bones in her left ankle, had back surgery and right knee meniscus tear after receiving treatment with synvisc one.No past drugs, medical history, concomitant medication or concurrent condition was reported.On an unk date in (b)(6) 2014, the pt received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number and expiration date: not provided) into an unspecified location for osteoarthritis.It was reported that the pt was not having pain.On an unk date in (b)(6) 2014, about a month after the injection, the pt broke 3 bones in her left ankle and was wearing a surgical boot.It was reported that wearing the boot caused the right knee meniscus tear.On an unk date (four months ago), the pt received a cortisone injection which did not work and the pt was referred to her healthcare professional (hcp).On an unk date (last month), the pt had back surgery.Corrective treatment: surgical boot for broken 3 bones in her left ankle not reported for back surgery and right knee meniscus tear.Outcome: not recovered for right knee meniscus tear and unk for other two events.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Seriousness criteria: important medical event (ime) for broken 3 bones in her left ankle and required intervention for back surgery.

Manufacturer Narrative

Pharmacovigilance comment: sanofi company comment dated 04/21/2015: this case pertains to a female pt of (b)(6) who was administered synvisc one and after one month reported to have broken bones in her left ankle as per the temporal relationship between the event and product and role of the product cannot be denied.However due to lack of info regarding pt's underlying concurrent medical conditions and concomitant medications precludes the complete medical assessment of the case.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURFERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corporate dr; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4726172
• MDR Text Key: 16990627
• Report Number: 2246315-2015-50681
• 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
• Type of Report: Initial
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR