BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACRYLOC GHV G 40G

    MDR report key: 3076643 · Received April 25, 2013

    Report

    Report Number
    1818910-2013-15907
    Event Type
    Death
    Date Received
    April 25, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    9610921 DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    PK033563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATES THAT AFTER THE USE OF THE CEMENT THE PATIENT HAD A CARDIAC ARREST AND DIED. 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 WERE REVIEWED AND THEY ARE ALL WITHIN SPECIFICATION. THE RETAINED SAMPLES WERE TESTED FOR BENZOYLE PEROXIDE CONTENT, DMPT CONTENT AND IDENTIFICATION OF POLYMER AND MONOMETHYL METHACRYLATE. THE RESULTS WERE REVIEWED AND THESE ARE ALL WITHIN SPECIFICATION. THE DEVICE HISTORY WAS REVIEWED:NO NON CONFORMANCES ON THIS BATCH. FINAL MICRO AND STERILITY TESTS PASSED. A SEARCH OF THE COMPLAINT DATABASE FOUND COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE - BY LOT NUMBER - 0, BY PRODUCT CODE - 3, BY PRODUCT FAMILY - 5 (3X SMARTSET GHV GENTAMICIN, 2X SMARTSET GMV ENDURANCE GENTAMICIN). 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.

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

    Description of Event or Problem · 1

    HEMI HIP ARTHROPLASTY- AFTER THE USE OF THE CEMENT THE PATIENT HAD A CARDIAC ARREST AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179312 ACRYLOC GHV G 40G BONE CEMENT LOD 9610921 DEPUY CMW 3528516

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death