BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 1210975 · Received October 23, 2008

    Report

    Report Number
    MW5008761
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    February 1, 2008
    Report Date
    October 23, 2008
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THREE SHOTS OF SYNVISC IN EARLY 2008. WITHIN A FEW DAYS OF THE THIRD SHOT, I STARTED GETTING STIFFNESS IN MY WEIGHTBEARING JOINTS. THIS BECAME INCREASINGLY WORSE FOR THE NEXT TWO MONTHS. I HAD DEBILITATING PAIN IN ALL JOINTS FROM THE HIPS DOWN AND PAIN IN THE FRONT MUSCLE OF THE THIGHS AND THE OUTSIDE MUSCLE IN THE LOWER LEG. IT WAS SO BAD, I WENT FROM WALKING 5 MILES REGULARLY AND EASILY TO BARELY MAKING IT TO THE CORNER. THE PAIN WAS SO BAD THAT I COULD NOT SLEEP WITH MEDIATION. GRADUALLY OVER A FEW MONTHS, MOST OF THE PAIN SUBSIDED EXCEPT IN MY KNEES. MY KNEES ARE A STILL VERY VERY STIFF AND SORE. WHEN THE PAIN WAS SEVERE, I WENT BACK TO THE ORTHOPEDIST, WHO INSISTED THAT THIS WAS NOT AN ALLERGIC REACTION TO THE SYNVISC. HE SAID A SYSTEMIC REACTION COULD NOT AFFECT ONLY WEIGHT BEARING JOINTS, THAT IT WOULD BE ALL MY JOINTS. I AM CONVINCED THAT THE SHOTS OF SYNVISC CAUSED SOME TYPE OF ARTHRITIS LIKE REACTION. ALTHOUGH I DID HAVE SURGERY TO REPAIR A TORN MENISCUS ORIGINALLY -IN 2007- THIS WAS A TOTALLY DIFFERENT TYPE OF PAIN. FREQUENCY: 3 SHOTS 1-WK APART. DATES OF USE: 2008 DIAGNOSIS OR REASON FOR USE: TO PROVIDE CUSHION BONE ON BONE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC NONE MOZ

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other