BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3151488 · Received June 7, 2013

    Report

    Report Number
    1818910-2013-05511
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 1, 2011
    Report Date
    January 11, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

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

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON (B)(6) 2009, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS RIGHT SIDE. PATIENT HAS SINCE THEN SUFFERED ECONOMIC LOSSES INCLUDING, BUT NOT LIMITED TO, LOSS OF HIS JOB, LOSS OF INCOME AND FRINGE BENEFITS, AND MEDICAL, PHARMACEUTICAL AND OTHER INCIDENTAL EXPENSES. THERE IS NO MENTION OF A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253364 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2864986

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention