BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3163456 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-06892
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    August 17, 2011
    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. 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE FOLLOWING: SINCE COMPLETION OF PATIENTS HIP REPLACEMENT SURGERIES, PATIENT HAS SUFFERED FROM INJURIES OF A PERMANENT, LASTING AND PAINFUL NATURE. PATIENTS ABILITY TO PERFORM NORMAL AND ENJOY REGULAR ACTIVITIES HAS BEEN IMPAIRED. PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264322 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2777243

    Patients

    Seq Age Sex Outcome Treatment
    1 Other