BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2820451 · Received November 6, 2012

    Report

    Report Number
    1818910-2012-22861
    Event Type
    Death
    Date Received
    November 6, 2012
    Report Date
    October 18, 2012
    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
    NJ, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). LITIGATION ALLEGES PATIENT HAD PAIN AND WRONGFUL DEATH AFTER ASR HIP IMPLANT. ALTHOUGH WRONGFUL DEATH IS CLAIMED IN THE LITIGATION, NO INFORMATION REGARDING THE DEATH WAS PROVIDED. DEPUY STILL 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

    PATIENT SEEKING LEGAL ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2612547

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O