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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Arthritis (1723); Hemorrhage/Bleeding (1888); Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

This unsolicited device case from united states was received on (b)(6) 2014 from the pt.This case involves an (b)(6) y/o female pt who could barely walk, her left knee was painful, had nose bleeds and pt-inr too high after receiving treatment with synvisc one and warfarin sodium (coumadin).No medical history, concomitant medications and concurrent conditions were reported.It was reported that pt initially received the synvisc (3 injections) in both knees about 4 or 5 years ago and at first she had pain but it helped, after that she received synvisc one in bilateral knees about every six months.On (b)(6) 2014, the pt received treatment with synvisc one injection at a dose of 6 ml, once (route, batch/lot number and expiry date; not provided) in both knees for osteoarthritis.On the same day, pt's left knee was painful.It was reported that pt could barely walk out of the office on it and iced it a lot.Pt reported that after about 48 hours, knee improved and that pt's physician wanted pt to have surgery on knees.On an unspecified date, the pt initiated treatment with warfarin sodium daily (dose, route, frequency, form, batch/lot number was expiration date: not provided) for atrial fibrillation.On (b)(6) 2014, pt had her prothrombin time - international normalised ratio (pt-inr) and the result was at 4.4 (too high) (units and normal ranges: not provided) with her goal pt-inr at 2.5 to 3.The pt was not sure if she did changed her diet that significantly to cause this.It was reported that pt liked green vegetables and that there were some days that she did not have as many vegetables during this time but she was not certain.Pt was instructed not to take her warfarin sodium.On (b)(6) 2014, pt's pt-inr was 2.2.Pt wanted to know if the synvisc one injections that could have caused the elevated pt-inr tests.Further reported, after taking warfarin sodium pt had nose bleeds especially in the winter time with the dry air.Pt could not take chondroitin tablets for supplements for her knees because the pills over the years since getting the injections of the synvisc product and wanted to know if this injection could also cause that.Action taken: stopped temporarily for warfarin sodium.Outcome: recovered for pt-inr too high, recovering for her left knee was painful, and unk for rest of the events.Seriousness criterion: important medical event for pt-inr too high.

Manufacturer Narrative

A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same pharmacovigilance comment: sanofi company comment dated (b)(4) 2014: this case concerns the pt who experienced increased pt-inr while receiving synvisc one for osteoarthritis.Although the role of the device cannot be ruled out, however, co-suspect drug coumadin may play a confounding role in the occurence of event.

• Brand Name: SYNVISC ONE
• 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: 4195982
• MDR Text Key: 5152415
• Report Number: 2246315-2014-42974
• 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: Consumer
• Type of Report: Initial
• Report Date: 10/15/2014

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 10/21/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR