BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 2674257 · Received July 30, 2012

    Report

    Report Number
    1818910-2012-17667
    Event Type
    Death
    Date Received
    July 30, 2012
    Date of Event
    July 19, 2012
    Report Date
    July 25, 2012
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    K033563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE RETAINED SAMPLES WERE CONDITIONED AND TESTED AT AN AMBIENT TEMPERATURE OF 23 DEG C. ALL HANDLING AND SETTING TIME RESULTS, DMPT RESULTS AND BPO RESULTS WERE REVIEWED AND THEY ARE ALL WITHIN SPECIFICATION. A SEARCH OF THE COMPLAINT DATABASE FOUND COMPLAINTS RECEIVED BY (B)(4) IN THE LAST 12 MONTHS FOR THIS ISSUE - BY LOT NUMBER - 0; BY PRODUCT CODE - 3; BY PRODUCT FAMILY - 11 (HV 1, GHV 3, MV 3, GMV 4). THE DEVICE HISTORY WAS REVIEWED: 3 UNRELATED NON CONFORMANCES ON THIS BATCH. MICRO AND STERILITY TESTS PASSED. 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 AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    PRODUCT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER (B)(4). 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 DEATH. HAPPENED AFTER INSERTING THE FINAL FEMORAL IMPLANT AFTER RETROGRADE CEMENT FILLING INTO THE FEMORAL CANAL. SUBCAPITAL FRUCTURES CONVERTED TO HEMI ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET GHV GENTAMICIN 40G DEPUY BONE CEMENT LOD DEPUY CMW 3409070

    Patients

    Seq Age Sex Outcome Treatment
    1 Death