BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 2924654 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-02178
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    September 7, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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 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. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT SINCE COMPLETION OF THE HIP REPLACEMENT SURGERY, THE PATIENT HAS SUFFERED FROM INJURIES OF A PERMANENT, LASTING AND PAINFUL NATURE. IT IS FURTHER ALLEGED THE PATIENT'S ABILITY TO PERFORM NORMAL AND ENJOY REGULAR ACTIVITIES HAS BEEN IMPAIRED. THE PATIENT'S ABILITY TO PERFORM NORMAL AND ENJOY REGULAR ACTIVITIES HAS BEEN IMPAIRED AND THE PATIENT HAS BEEN TOLD THAT A REVISION IS NECESSARY TO REMOVE THE DEVICE. **UPDATE** (B)(6) 2011 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31035 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2118786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other