BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 513704 · Received February 26, 2004

    Report

    Report Number
    2246315-2004-00021
    Event Type
    Injury
    Date Received
    February 26, 2004
    Date of Event
    November 1, 2003
    Report Date
    February 26, 2004
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SWELLING OF RIGHT KNEE, ASPIRATION, PAIN IN KNEE, PAIN IN BOTH LEGS, {WEAKNESS OF RIGHT KNEE, LEG, NOT BEING ABLE TO PUT MUCH PRESSURE ON IT}, {COULDN'T BEND KNEES, USING CANE}, {TINGLING IN BOTH LEGS, SOFT BONES AND SQUISHING DOWN THE LEGS}. INFORMATION WAS RECEIVED IN JAN 2004 FROM A CONSUMER, WITH HISTORY OF BILATERAL KNEE OSTEOARTHRITIS, WHO RECEIVED A SERIES OF SYNVISC INJECTIONS IN EACH KNEE BEGINNING IN 2003. THE SECOND INJECTIONS WERE ADMINISTERED 3-4 DAYS LATER AND THE THIRD INJECTIONS WERE ADMINISTERED APPROX ONE WEEK LATER. THIS IS THE FIRST KNEE VISCOSUPPLEMENTATION THERAPY THAT THE PATIENT HAS RECEIVED. PATIENT EXPERIENCED 'TINGLING IN BOTH LEGS, SOFT BONES AND SQUISHING DOWN THE LEGS' AFTER BEGINNING THE SYNVISC THERAPY. TWO WEEKS AFTER THE LAST INJECTION, THEY COULD NOT BEND THEIR KNEES. THE TREATING PHYSICIAN REMOVED 70 ML OF FLUID FROM THE LEFT KNEE AFTER THE LAST INJECTION. IN 2004, THE RIGHT KNEE BEGAN TO SWELL AND WAS TREATED WITH AN INTRA-ARTICULAR INJECTION OF KENALOG (STEROID). AT THE TIME OF THIS REPORT, THE 'TINGLING, SOFT BONES AND SQUISHING DOWN THE LEGS' HAS RESOLVED. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFO WAS RECEIVED THE FOLLOWING MONTH FROM THE CONSUMER, WHO REPORTED THAT THEY RECEIVED A SERIES OF SYNVISC INJECTIONS. APPROX ONE HOUR FOLLOWING EACH INJECTION, THEY EXPERIENCED PAINS SHOOTING UP AND DOWN BOTH LEGS. AFTER THEY RECEIVED THE THIRD INJECTION THEY TOLD THEIR PHYSICIAN THEY WERE HAVING PROBLEMS. THEY HAD WEAKNESS ESPECIALLY IN THE RIGHT KNEE AND LEG WHICH CONTINUES. IN 2003 THE PATIENT RETURNED TO THEIR PHYSICIAN AND HAD 70 CC OF FLUID ASPIRATED FROM THE LEFT LEG. THEY HAD SEVERE PAIN AND COULD'T BEND THEIR KNEE. IN 2004, THEY CONTINUED HAVING SEVERE PAIN AND USED A CANE TO HELP THEM WALK. THEY RETURNED TO THEIR PHYSICIAN FOR EXAMINATION AND HE ADMINISTERED PATIENT 'REGULAR SHOT' TO HELP. THE WEAKNESS AND PAIN CONTINUES IN THE RIGHT KNEE AND THEY ARE UNABLE TO PUT MUCH PRESSURE ON IT. PRESENTLY THEY CAN'T WALK WITHOUT USE OF THE CANE. IF THIS CONTINUES, THEY WILL HAVE SURGERY SOONER THAN THEY EXPECTED. THEY STILL NEED TO USE THE CANE WHEN THEY WALK AND IF PATIENT DOESN'T, THEY EXPERIENCE SEVERE PAIN IN THEIR RIGHT KNEE WHICH IS NOW BONE ON BONE AND THE LEFT KNEE IS SENSITIVE TO WALK ON. NO FURTHER DETAILS WERE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention