BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTSET MV ENDURANCE 40G

    MDR report key: 2431565 · Received January 30, 2012

    Report

    Report Number
    1818910-2012-02703
    Event Type
    Death
    Date Received
    January 30, 2012
    Date of Event
    May 31, 2011
    Report Date
    August 2, 2012
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    P960001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES WERE CONDITIONED AND TESTED AT AN AMBIENT TEMPERATURE OF 23 DEG C. ALL TESTING RESULTS WERE REVIEWED AND THEY ARE ALL WITHIN SPECIFICATION. THE DEVICE HISTORY RECORDS WERE REVIEWED, NO NON CONFORMANCES ON THIS BATCH THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    UPDATED INFORMATION RECEIVED 8/3/2012.

    Description of Event or Problem · 1

    HAPPENED WHILE INSERTING THE FINAL FEMORAL IMPLANT AFTER RETROGRADE CEMENT FILLING INTO THE FEMORAL CANAL. THE SURGEON CLAIMS THAT EVENT HAPPEND FOLLOWING THE USE OF THE REPORTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET MV ENDURANCE 40G BONE CEMENT LOD DEPUY CMW 3276583

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death