BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SZ 51

    MDR report key: 1905556 · Received November 19, 2010

    Report

    Report Number
    1818910-2010-08533
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4).

    Additional Manufacturer Narrative · 1

    NO 510 (K) NUMBER PROVIDED BECAUSE THIS IMPLANT WAS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT WAS 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

    PATIENT PRESENTED WITH PAINFUL HIP WITH EROSION OF THE CALCAR ON HIS LEFT FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SZ 51 TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL, LTD NA 2268693

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention