MAUDE Adverse Event Report: GENZYME CORPORATION HYALURONATE FOR INTRAARTICULAR INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Swelling (2356); Reaction (2414)

Event Date 05/26/1999

Event Type  Injury  

Event Description

A (b)(6) yo female with known osteoarthritis of the knees, xray and clinical exam.Poorly tolerant of nsaids.We agreed on a series of synvisc injections for the left knee, which were done on (b)(6) 1999.Each injection seemed technically satisfactory, with the synvisc being injected within the joint space.On (b)(6) 1999, the patient developed severe left knee pain.She was seen on (b)(6) 1999, and there appeared to be mild warmth and swelling.C - reactive protein was 2.8, (normal < 1.4).No fever, a diagnostic left knee aspiration was performed; no fluid was obtained (dry tap).She was treated with choline mg salicylate.She was re-examined on (b)(6) 1999, and the knee was significantly better (back towards baseline), without effusion.I believe pt had a reaction to the synvisc, without infection (she received no antibiotics), although i can't rule out the possibility of a crystalline arthritis (e.G., pseudogout) triggered by the injections.

• Brand Name: HYALURONATE FOR INTRAARTICULAR INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10836811
• MDR Text Key: 216370456
• Report Number: MW5097844
• 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: Physician
• Type of Report: Initial
• Report Date: 06/18/1999
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 113