BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2061156 · Received January 6, 2011

    Report

    Report Number
    1818910-2011-00131
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 16, 2010
    Report Date
    December 7, 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
    CA, US
    Reporter Occupation
    OTHER

    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

    USER FACILITY MEDWATCH REPORT STATES: PT WITH A HISTORY OF OSTEOARTHRITIS UNDERWENT A RIGHT TOTAL HIP REPLACEMENT IN 2006. THE PT EXPERIENCED SQUEAKING AND PAIN. THE PT'S ION LEVELS WERE ELEVATED. A RIGHT TOTAL HIP REVISION WAS DONE AND THE ASR ACETABULAR CUP REMOVED. A COMPETITOR'S CUP/LINER AND DEPUY HEAD WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2168215

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention