BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 3050473 · Received April 10, 2013

    Report

    Report Number
    1818910-2013-02839
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 13, 2013
    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
    NY, 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 ALLEGED TH PATIENT SUFFERED PAIN, SORENESS, SUBCUTANEOUS SCAR TISSUE AND DAMAGE, INCREASED LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD, BONE AND TISSUE DETERIORATION, DECREASED MOBILITY, WEIGHT LOSS, FATIGUE, AND NAUSEA AS A RESULT OF THE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153682 ASR UNI FEMORAL IMPL SIZE 51 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2859605

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention