BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR RESURFACING HIP

    MDR report key: 2011332 · Received March 4, 2011

    Report

    Report Number
    1818910-2011-03455
    Event Type
    Injury
    Date Received
    March 4, 2011
    Report Date
    February 2, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 PT REC'D A DEPUY ASR XL AND A DEPUY ASR RESURFACING HIP. THE PT HAS SUBSEQUENTLY DEVELOPED GENERAL PAIN AND STIFFNESS AND NOW FACES THE POSSIBILITY OF REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR RESURFACING HIP 87KWA KWA DEPUY INTERNATIONAL, LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention