BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 1945552 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-10205
    Event Type
    Injury
    Date Received
    December 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE PATIENT'S IMPLANTS ARE BEGINNING TO PRODUCE METALLIC FRAGMENTS. IT IS FURTHER ALLEGED THAT BLOOD TESTING CONFIRMED ELEVATED BLOOD ION LEVELS OF COBALT-CHROMIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 52 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2709808

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention