BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 2831800 · Received November 14, 2012

    Report

    Report Number
    1818910-2012-24576
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 22, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    PMA / PMN Number
    K060031
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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 ALLEGED THE PATIENT SUFFERED PAIN, DECREASE MOBILITY, OCCASIONAL CLICKING AND/OR POPPING AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR FEMORAL HEAD FEMORAL HEAD HIP IMPLANT KXA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O