BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2011451 · Received March 4, 2011

    Report

    Report Number
    1818910-2011-03646
    Event Type
    Injury
    Date Received
    March 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN
    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 PAPERS ALLEGE THE PATIENT'S RIGHT HIP WAS REVISED DUE TO EXCRUCIATING PAIN, MULTIPLE DISLOCATIONS OF THE IMPLANTED HIP SYSTEM AND THE INABILITY TO WALK. THE LEFT HIP REMAINS IMPLANTED. IT IS FURTHER ALLEGED THAT THE PATIENT HAS SUFFERED INJURIES AND DAMAGES FROM METAL-ON-METAL WEAR, WHICH HAS RESULTED IN HER HAVING ELEVATED LEVELS OF CHROMIUM AND COBALT IN HER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2156738

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention