BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 2213946 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-14859
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 15, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. (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.

    Additional Manufacturer Narrative · 1

    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

    LITIGATION PAPERS ALLEGE THE PATIENT HAD PERSISTENT SEVERE PAIN AND DISCOMFORT IN HIS RIGHT HIP, BUTTOCKS, GROIN, AND THIGH, WHICH HAS INCREASED OVER TIME; SENSATION OF MISALIGNMENT, WEAKNESS, AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING SUCH AS WALKING AND STANDING AFTER BEING SEATED. IT IS ADDITIONALLY ALLEGED THE PATIENT SUFFERS FROM ELEVATED, IF NOT TOXIC, LEVELS OF COBALT METAL IONS IN HIS BLOODSTREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 53 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2868844

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention