BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREMET

    MDR report key: 2171291 · Received July 14, 2011

    Report

    Report Number
    MW5021397
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    January 4, 2010
    Report Date
    July 14, 2011
    Manufacturer
    STRYKER
    Product Code
    KXA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, I RECEIVED HIP RESURFACING ON MY RIGHT HIP. SHORTLY THEREAFTER, PAIN DEVELOPED. ONE YEAR LATER, BLOOD TEST REVEALED VERY HIGH LEVELS OF COBALT (52) AND CHROMIUM (37) IONS IN MY BLOOD. ORIGINATING SURGEON ADVISED THE ORIGINAL DEVICE (STRYKER - COREMET) NEEDED TO BE REMOVED. ON (B)(6) 2011, I HAD REVISION SURGERY TO TRADITIONAL HIP REPLACEMENT. ORIGINAL DEVICE CAUSED APPROXIMATELY 33% OF THE FEMUR TO BE NECROTIC, NECESSITATING REMOVAL OF THE ENTIRE BALL JOINT. PHYSICAL THERAPY (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COREMET HIP RESURFACING SYSTEM KXA STRYKER

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| S