BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2253903 · Received September 19, 2011

    Report

    Report Number
    1818910-2011-18436
    Event Type
    Injury
    Date Received
    September 19, 2011
    Report Date
    August 22, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT EXPERIENCES PAIN FROM HIS RIGHT HIP AND HAS INCURRED OUT-OF-POCKET EXPENSES, AND COSTS TO ATTEND HIS MEDICAL CARE APPOINTMENTS. IT IS ALSO ALLEGED THE PATIENT COULD NOT HAVE KNOWN THAT HE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE HE HAD HIS BLOOD DRAWN AND HE WAS ADVISED OF THE RESULTS OF SAID BLOOD-WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2917933

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention