BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTSET GMV ENDURANGE 40G (ANTIBIOTIC BONE CEMENT)

    MDR report key: 6303979 · Received February 6, 2017

    Report

    Report Number
    1818910-2017-11952
    Event Type
    Death
    Date Received
    February 6, 2017
    Date of Event
    February 5, 2017
    Report Date
    February 5, 2017
    Manufacturer
    DEPUY CMW ¿ REG. # 9610921
    Product Code
    MBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DHR AND COMPLAINT HISTORY REVIEW COMPLETED. NO NON-CONFORMANCES ON THIS BATCH. FINAL MICRO AND STERILITY TESTS PASSED. A COMPLAINT DATABASE SEARCH FINDS NO ADDITIONAL REPORTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. BASED ON THE INABILITY TO FIND ANY OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE, IT IS REASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. (B)(4) HAS BEEN REVIEWED AND INCLUDES CARDIOVASCULAR EVENT AS A POTENTIAL HARM WITH A SEVERITY OF 10 AND OCCURRENCE OF 2. THE IFU WAS REVIEWED AND CONTAINS THE FOLLOWING WARNING: "THE FOLLOWING SERIOUS AND FREQUENT ADVERSE REACTIONS MAY OCCUR DURING OR FOLLOWING THE USE OF BONE CEMENT BUT ARE NOT NECESSARILY DIRECTLY RELATED TO THE ACRYLIC BONE CEMENT ITSELF. THE SURGEON SHOULD BE AWARE OF THESE REACTIONS AND BE PREPARED TO TREAT SUCH REACTIONS IF THEY ARE ENCOUNTERED. SERIOUS: MYOCARDIAL INFARCTION, CEREBROVASCULAR ACCIDENT, CARDIAC ARREST, SUDDEN DEATH AND (PULMONARY EMBOLISM. MOST FREQUENT: TRANSITORY FALL IN BLOOD PRESSURE, THROMBOPHLEBITIS, HAEMORRHAGE AND HAEMATOMA LOOSENING OR DISPLACEMENT OF THE PROSTHESIS, SUPERFICIAL OR DEEP WOUND INFECTION, TROCHANTERIC BURSITIS, AND SHORT TERM CARDIAC CONDUCTION IRREGULARITIES." RETAINED SAMPLES WERE CONDITIONED AND TESTED AT AN AMBIENT TEMPERATURE OF 23 DEGREES CELSIUS. THE BATCH WAS TESTED FOR BPO, DMPT, DOUGH TIME/ SETTING TIME AND HANDLING CHARACTERISTICS, AND IR TESTING ON POWDER AND LIQUID COMPONENTS. THE RESULTS WERE REVIEWED AND THESE ARE ALL WITHIN SPECIFICATION. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). THERE IS NO 510K NUMBER, AS THIS PRODUCT IS SOLD UNDER A DIFFERENT PRODUCT CODE IN THE U.S. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE PATIENT ACCEPTED HEMIARTHROPLASTY ON (B)(6) 2017. THE CEMENT WAS INJECTED TO MEDULLARY CAVITY SMOOTHLY. AFTER 5 MINUTES THE BLOOD PRESSURE OF PATIENT DROPPED AND HEART SLOWED DOWN. THE SURGEON TRIED HIS BEST TO SAVE HER LIFE BUT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86767 SMARTSET GMV ENDURANGE 40G (ANTIBIOTIC BONE CEMENT) CEMENT / CEMENT ACCESSORY MBB DEPUY CMW ¿ REG. # 9610921 7822322

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death