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

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 61 YR
• Patient Weight: 95