MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Pain (1994); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 07/22/2021

Event Type  Injury  

Event Description

This is the 2nd adverse reaction to synvisc injections in both knees.The 1st time was on (b)(6) 2021 then again on (b)(6) 2021.Severe swelling and pain in both knees occurred and the knees were unable to support me to walk, if sitting i was unable to stand.This happened with the 2nd and 3rd injections in the 3 week series of injections.The pain began under the knee caps 7 hrs after the injections and continued to extreme swelling surrounding both knees and they were unable to bend or support standing, walking and getting up from a sitting position.I elevated, iced and took ibuprofen and cyclobenzaprine for the pain and muscle spasms but neither of those medications eliminated the pain, swelling or muscle spasms.My pain score was a 10 plus.No testing was done.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 12226698
• MDR Text Key: 263975701
• Report Number: MW5102783
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 07/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• 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): Other
• Patient Age: 69 YR
• Patient Weight: 75