BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2874752 · Received December 16, 2012

    Report

    Report Number
    1818910-2012-29138
    Event Type
    Injury
    Date Received
    December 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
    TX, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: SUFFERS FROM PAIN IN HER LEG AND HIP AREA WHEN WALKING, HAS A NOTICEABLE LIMP AND MUST USE A CANE FOR STABILITY. IN ADDITION IS HARD FOR HER TO GO PLACES, FOR INSTANCE, TO DOCTORS APPOINTMENTS, BECAUSE IT IS SO DIFFICULT AND PAINFUL TO GET IN AND OUT OF AN AUTOMOBILE. **UPDATE: (B)(6) 2011 PLAINTIFF FACT SHEET RECEIVED WITH PART/LOT INFORMATION,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2872820

    Patients

    Seq Age Sex Outcome Treatment
    1