MAUDE Adverse Event Report: GENZYME CORP. SYNVISC ONE ACID, HYALURONIC, INTRAARTICULAR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 04/28/2018

Event Type  Injury  

Event Description

Received outpatient injection of 4ml of synvisc (hyaluronic acid) in left knee on (b)(6) 2018 (13:00 ct) at orthopedic surgery and sports medicine outpatient clinic (opc building, floor 25) of houston methodist hospital. Suffered severe effusion and joint pain 48-96 hours post injection. Still difficult to walk on left leg 5 days post-injection. Case reports (publications) call this a type iv immune response similar to a positive tb test, since this is my 3rd injection over a 5 year period (already exposed to antigen). Suspect: yes. Primary: yes. Product type: drug/biologic. Synviscone. Com. Strength: 4 ml millilitre(s). Did the problem stop after the person reduced the dose or stopped taking or using the product: no. Did the problem return if the person started taking or using the product again: yes. Do you still have the product in case we need to evaluate it: no. Quantity: other: 1 injection. How was it taken or used: injected in synovial sac. Date the person first started taking or using the product: (b)(6) 2015. Date the person stopped taking or using the product: (b)(6) 2018.

• Brand Name: SYNVISC ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORP.
• MDR Report Key: 7486209
• MDR Text Key: 107489511
• Report Number: MW5077003
• Device Sequence Number: 1
• 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

• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 05/03/2018 Patient Sequence Number: 1