BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SZ 51

    MDR report key: 1945732 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-09992
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 30, 2010
    Manufacturer
    DEPUY INT'L., LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE U.S. UNDER A DIFFERENT PART NUMBER. 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

    PAIN TISSUE LOSS AND REACTION AND BONE LOSS DUE TO REACTION TO THE METAL ON METAL ARTICULATION. REVISION: TOTAL HIP REPLACEMENT FOR TISSUE REACTION TO METAL ON METAL ARTICULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SZ 51 TOTAL HIP REPLACEMENT KXA DEPUY INT'L., LTD. NA 2420406

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention