BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SZ 46

    MDR report key: 2232781 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15794
    Event Type
    Injury
    Date Received
    August 18, 2011
    Report Date
    July 22, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE SUBJECT UNDERWENT PRIMARY TOTAL HIP REPLACEMENT IN (B)(6) 2006 FOR DEVELOPMENTAL DYSPLASIA OF THE HIP. IT WAS REPORTED IN (B)(6) 2011 THAT THE SUBJECT HAD BEEN REVIEWED AND HAD BLOOD METAL ION TESTS AS PART OF THE ASR RECALL AND HAS HIGH COBALT LEVELS. RIGHT HIP. REVISION (B)(6) 2011. A GREY STAINED EFFUSION WAS FOUND WITHIN THE JOINT CAPSULE AND THE SYNOVIUM INSIDE THE CAPSULE WAS STAINED ALSO. THE PT HIP WAS NOT REVISED AND REMAINS IN SITU. COBALT LEVELS WERE FOUND TO BE 1500NMOL/L AND CHROMIUM 1000NMOL/L. THE SUBJECT WAS OTHERWISE ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SZ 46 TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL, LTD. NA 1849619

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention