BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 2570988 · Received May 11, 2012

    Report

    Report Number
    1818910-2012-12461
    Event Type
    Death
    Date Received
    May 11, 2012
    Date of Event
    March 13, 2012
    Report Date
    May 23, 2012
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    K033563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES WERE CONDITIONED AND TESTED AT AN AMBIENT TEMPERATURE OF 23 DEG C. ALL RESULTS WERE REVIEWED AND THEY ARE ALL WITHIN SPECIFICATION. A SEARCH OF THE COMPLAINT DATABASES FOUND ONE PREVIOUS COMPLAINT AGAINST THE PRODUCT CODE AND LOT CODE COMBINATION. A REVIEW OF DEVICE HISTORY RECORDS FOUND ONE NON-CONFORMANCE ON THIS BATCH FOR DEAGGLOMERATION. THIS NON CONFORMANCE DOES NOT AFFECT THE COMPLAINT FAILURE MODE. MICRO AND STERILITY TESTS PASSED. THE INVESTIGATION DID 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

    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 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 CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY

    Description of Event or Problem · 1

    DEATH OF PATIENT FOLLOWING ORTHOPAEDIC CEMENTING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET GHV GENTAMICIN 40G BONE CEMENT LOD DEPUY CMW 3310529

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death