BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2071694 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06371
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS HIP DISCOMFORT AND OSTEOLYSIS. **UPDATE** (B)(6) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH INDICATES THAT PATIENT IS SEEKING LEGAL ACTION. **UPDATE** (B)(6) 2013 - LITIGATION PAPERS RECEIVED (B)(6) 2012 ALLEGE PATIENT SUFFERED INCREASED PAIN; IMPAIRED ABILITY TO PERFORM NORMAL DAILY ACTIVITIES, WORK, SLEEP AND WALK; INCREASED METAL ION LEVELS.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS HIP DISCOMFORT AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 87KWA KWA DEPUY INTERNATIONAL, LTD NA 2350085

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention