MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/10/2017

Event Type  Injury  

Event Description

I received a synvisc one injection one (b)(6) 2016.(i have had synvisc previously, over 3 years ago, delivered in 3 separate doses).Over the course of the last two weeks.I have had increased swelling in the knee, culminating last night when it woke me from sleep at 2am with severe pain.The entire joint is over 3 cm larger in diameter, the pain radiated posterior knee down the back of the calf, and i was unable to weight bear on the extremity.Today, i had to leave work for an emergency appointment with my orthopedist, where i reluctantly received a cortisone shot, something i was trying to avoid due to my history of having cortisone in the past.It is still extremely swollen and painful, with restricted rom and abnormal gait pattern.Date the person first started taking or using the product: (b)(6) 2017.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.

• Brand Name: SYNVISC ONE
• Type of Device: SYNVISC ONE
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 6328575
• MDR Text Key: 67476782
• Report Number: MW5067853
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 43 YR
• Patient Weight: 52