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

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

Patient Problems Edema (1820); Pain (1994); Loss of Range of Motion (2032)

Event Date 02/09/1998

Event Type  Injury  

Event Description

Pt was received injections into her knees for bilateral osteoarthritis.In the right knee pt received 5 doses of hyalgan injection without a problem.In the left knee, pt received synvisc.After the third injection of synvisc, the pt developed severe pain, a tense effusion and decrease range of motion of the left knee.An aspirate of the knee revealed joint fluid 15,000 rbc, 7,000 wbc and no crystals.The pt was admitted to the hospital for vest, pain control and physical therapy.She improved over a 10 day hospitalization.She was diagnosed with toxic "synouhs" secondary to synvisc injection.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10836839
• MDR Text Key: 216409733
• Report Number: MW5097846
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 07/23/1998

1 Device was Involved in the Event

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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR