BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 46

    MDR report key: 2840554 · Received November 20, 2012

    Report

    Report Number
    1818910-2012-24207
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    August 30, 2012
    Report Date
    August 23, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    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 US 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 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). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT WAS FOUND TO HAVE ELEVATED COBALT AND CHROMIUM LEVELS. BECAUSE THE BILATERAL ASR HIP IMPLANTS CONTINUED TO DETERIORATE, THE PATIENT UNDERWENT BILATERAL HIP REVISION SURGERY. THE PATIENT SUFFERED INJURIES OF A PERMANENT NATURE; ENDURED PAIN AND SUFFERING AND IS UNABLE TO ATTEND TO HER NORMAL AFFAIRS AND DUTIES FOR AN INDEFINITE PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 46 FEMORAL HEAD HIP IMPLANT KXA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention