MAUDE Adverse Event Report: GENZYME SYNVISC ONE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Ambulation Difficulties (2544)

Event Date 06/07/2017

Event Type  Injury  

Event Description

My doctor injected synvisc one into my right knee due to lack of cartilage.After the injection i was barely able to walk for three months.With some concern i elected to have the shot in my left knee and it was ok.I have since found out that there was a problem with the syringe that come with synvisc one and can cause an infection with pain.Date the person stopped taking or using the product: (b)(6) 2017.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Why was the person using the product: osteoarthritis.

• Brand Name: SYNVISC ONE
• Type of Device: SYNVISC ONE
• Manufacturer (Section D): GENZYME
• MDR Report Key: 7224591
• MDR Text Key: 98566716
• Report Number: MW5074929
• Device Sequence Number: 0
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 70 YR
• Patient Weight: 95