BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY ORTHOPAEDICS - JOHNSON AND JOHNSON

    MDR report key: 1993064 · Received February 10, 2011

    Report

    Report Number
    MW5019408
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 10, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS - JOHNSON AND JOHNSON
    Product Code
    KXA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BOTH HIPS REPLACED IN (B)(6) 2008 AND (B)(6) 2008 WITH DEPUY PINNACLE IMPLANT AND SUMMIT CUP (METAL ON METAL). MY RIGHT HIP NEVER FELT RIGHT, I HAVE HAD A LIMP AND POPPING SINCE SURGERY. ON (B)(6) 2011, MY DOCTOR ORDERED BLOOD WORK. I HAVE JUST FOUND OUT THAT MY SERUM COBALT AND CHROMIUM LEVELS ARE ELEVATED AT 5.1 MCG/L AND 3.2 MCG/L. DATES OF USE: (B)(6) 2008 - (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ORTHOPAEDICS - JOHNSON AND JOHNSON 'SUMMIT' FEMORAL STEM KXA DEPUY ORTHOPAEDICS - JOHNSON AND JOHNSON UNKNOWN
    2 DEPUY ORTHOPAEDICS - JOHNSON AND JOHNSON 'PINNACLE' CUP KWA DEPUY ORTHOPAEDICS - JOHNSON AND JOHNSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other