BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 481665 · Received September 3, 2003

    Report

    Report Number
    2246315-2003-00035
    Event Type
    Injury
    Date Received
    September 3, 2003
    Date of Event
    June 2, 2003
    Report Date
    September 3, 2003
    Manufacturer
    GENZYME CORPORATION, GENZYME BIOSURGERY
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    KNEE EFFUSION; KNEE PAIN; KNEE SWELLING. INFO WAS RECEIVED IN 2003 FROM A PHEUMATOLOGIST VIA A RADIOLOGIC TECHNOLOGIST, REGISTERED (RTR), REGARDING A PT, WITH A HISTORY OF OSTEOARTHRITIS (OA) AND GOUT. THE PT RECEIVED THEIR FIRST SERIES OF THREE SYNVISC INJECTIONS TO THE LEFT KNEE (DATES AND OUTCOME UNK). THE PT RECEIVED A SECOND SERIES OF THREE SYNVISC INJECTIONS TO THE LEFT KNEE IN 2003. IN 2003, THE PT'S PHYSICIAN ASPIRATED 45 CC OF SYNOVIAL FLUID FROM THE LEFT KNEE. THE RTR REPORTED THAT THE PT RECEIVED THE THIRD SYNVISC INJECTION WITHOUT ASPIRATION OF SYNOVIAL FLUID, AND DID NOT RETURN FOR FOLLOW-UP. ADDITIONAL INFORMATION WAS RECEIVED IN 2003 FROM THE PT'S RHEUMATOLOGIST, WHO REPORTED THAT THE PT HAS A HISTORY OF SEVERE OA IN THE LEFT KNEE WITH A HISTORY OF PRIOR EFFUSIONS. THE PT HAS BEEN TREATED FOR THEIR OA WITH NSAIDS, STEROIDS, AND BEXTRA 10 MG (PO) DAILY, BUT HAS NOT RECEIVED PRIOR VISCOSUPPLEMENTATION TREATMENT. THE PT HAS BEEN TREATED FOR THEIR GOUT WITH ALLOPURINOL 300 MG (PO) DAILY AND COLCHICINE 0.6 MG (PO) DAILY AND IN ADDITION, THE PT TAKES "CLONOCHINE HCL" 0.2 MG THREE TIMES A DAY (INDICATION UNK). THE RHEUMATOLOGIST REPORTED THAT PRIOR TO THE FIRST SYNVISC INJECTION HE ASPIRATED 40 CC OF SYNOVIAL FLUID FROM THE PT'S KNEE. FOLLOWING THE FIRST INJECTION, THE PT EXPERIENCED KNEE PAIN AND SWELLING. IN 2003, THE RHEUMATOLOGIST ASPIRATED 85 CC OF SYNOVIAL FLUID FROM THE PT'S KNEE AND SET THE FLUID FOR ANALYSIS (RESULTS NOT PROVIDED). FOLLOWING THE SECOND INJECTION, THE RHEUMATOLOGIST ASPIRATED 25 CC OF SYNOVIAL FLUID FROM THE PT'S KNEE AND FOLLOWING THE INJECTION, THE PT CONTINUED TO EXPERIENCE KNEE PAIN AND SWELLING, AND AN EFFUSION. IN 2003, THE PT'S SWELLING WAS TREATED BY ASPRIATING 65 CC OF SYNOVIAL FLUID AND WITH THE ADMINISTRATION OF A CELESTONE INJECTION TO THE KNEE. AT THE TIME OF THIS REPORT, THE PT'S OUTCOME IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC HYLAN G-F 20 MOZ GENZYME CORPORATION, GENZYME BIOSURGERY NA N0308

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention