BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 2211780 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-15423
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    September 24, 2009
    Report Date
    June 24, 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
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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

    LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6) 2009 TO THE PRESENT, PT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES AS A RESULT OF THE IMPLANTATION OF THE ASR HIP IMPLANT: INABILITY TO LEAD A NORMAL LIFE, ANXIETY, FEAR, PAIN, SUFFERING, MENTAL ANGUISH, DIFFICULTY WALKING AND OTHER EMOTIONAL AND PHYSICAL CHANGES. IT IS FURTHER ALLEGED PT COULD NOT HAVE KNOWN THAT SHE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE SHE HAD HER BLOOD DRAWN AND SHE WAS ADVISED OF THE RESULTS OF SAID BLOOD-WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 48 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2138410

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention