BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER HIP IMPLANT

    MDR report key: 6375895 · Received February 28, 2017

    Report

    Report Number
    MW5068231
    Event Type
    Injury
    Date Received
    February 28, 2017
    Date of Event
    October 17, 2016
    Report Date
    February 28, 2017
    Manufacturer
    ZIMMER
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, MY ORTHOPEDIC SURGEON SAMPLED MY BLOOD AS PART OF PERIOD MONITORING OF MY METALIC ZIMMER HIP IMPLANT. THE BLOOD TEST FOUND 2.3 MCG/L OF CHROMIUM AND 7.6 MCG/L OF COBALT. HE RECOMMENDED THAT THE DEVICE BE REPLACED. THE REPLACEMENT TOOK PLACE ON (B)(6) 2016. DURING THE PLACEMENT, THE SURGEON NOTED CORROSION BETWEEN THE STEM AND THE BALL AND NOTED IT ON THE OPERATIVE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146448 ZIMMER HIP IMPLANT ZIMMER HIP IMPLANT KWA ZIMMER METASUS HEAD40 CODE F 2533451

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O