BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 3150712 · Received June 6, 2013

    Report

    Report Number
    1818910-2013-06887
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    January 17, 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
    CA, 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE FOLLOWING: ON OR ABOUT THE (B)(6) 2007, PRODUCTS WERE USED AND PLAINTIFF UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY SURGERIES IN WHICH DEPUY ASR COMPONENTS WERE USED AND PLACED INTO BOTH OF PATIENTS HIPS. PLAINTIFF WAS INJURED RESULTING IN SEVERE AND SERIOUS INJURY TO HIS PERSON. PATIENT FACT SHEET FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249866 ASR UNI FEMORAL IMPL SIZE 47 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2380322

    Patients

    Seq Age Sex Outcome Treatment
    1 Other