BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2832138 · Received November 14, 2012

    Report

    Report Number
    1818910-2012-24744
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    February 9, 2011
    Report Date
    August 16, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED EXTREME PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, LOSS OF ENERGY, IMMOBILIZATION, ACUTE AND LOCALIZED DAMAGE TO TISSUE AND BONE SURROUNDING THE ACETABULUM, SYSTEMATIC INJURIES, DISFIGUREMENT AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2193889

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention