BEUDAMED
    FDA Adverse Event Other Summary report: N

    JOHNSON + JOHNSON

    MDR report key: 2170647 · Received July 18, 2011

    Report

    Report Number
    MW5021379
    Event Type
    Other
    Date Received
    July 18, 2011
    Date of Event
    September 17, 2007
    Report Date
    July 5, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    STARTED HAVING SEVERE MUSCLE SPASMS THAT WOULDN'T LET UP. I COULDN'T SLEEP, STAND, SIT, I WAS IN UNRELENTING PAIN. THEY DETERMINED THAT NEW HIP REALIGNED ENOUGH TO KICK IN THE MUSCLE SPASMS. COULD HAVE BEEN A REACTION TO THE METAL IONS. TRANSITIONAL CELL CARCINOMA - ONE TUMOR REMOVED FROM THE BLADDER. RECURRENCE - 3 TUMORS REMOVED (B)(6) 2011. POSSIBLY CAUSED BY METALLOSIS SINCE I DON'T SMOKE OR WORK WITH CHEMICALS. DEVELOPED SEVERE PAIN IN LEFT EYE. VISITED (B)(4) ON (B)(6) 2011 AND THEY DIDN'T KNOW WHAT WAS WRONG. OPTOMETRIST DIAGNOSED IRITIS. HE SPECULATED I GOT SOMETHING IN MY EYE. IT CAN BE RELATED TO CROHN'S DISEASE. COULD THIS BE A REACTION TO METALLOSIS?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOHNSON + JOHNSON ASR XL ACETABULAR SYSTEM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. 2155103
    2 JOHNSON + JOHNSON ASR XL ACETABULAR SYSTEM UNIFEMORAL IMPLANT KXA DEPUY ORTHOPAEDICS, INC. 2192535
    3 JOHNSON + JOHNSON ASR XL ACETABULAR SYSTEM S ROM TOTAL HIP KWA DEPUY ORTHOPAEDICS, INC. 1922192
    4 JOHNSON + JOHNSON ASR XL ACETABULAR SYSTEM TAPER SLEEVE ADAPTER KXA DEPUY ORTHOPAEDICS, INC. 2185480

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other