BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECH CEM BOW SZ 12R 300MM

    MDR report key: 6120058 · Received November 22, 2016

    Report

    Report Number
    1020279-2016-00896
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    November 12, 2016
    Report Date
    May 4, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDI
    PMA / PMN Number
    K963486
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILST IMPLANTING THE STEM WHICH WAS ABOUT 5 MINUTES INTO IT BEING IMPLANTED, THE PATIENT HAD A CARDIAC ARREST. THE HIP WAS REDUCED AND THE STANDARD RESUSCITATION PROCEDURE COMMENCED. THE PATIENT COULD NOT BE REVIVED AND HAD PASSED ON. THE SURGEON WAS UNABLE TO COMPLETE THE PROCEDURE THEREFORE ONLY THE STEM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771755 ECH CEM BOW SZ 12R 300MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW, INC. 15MM03812

    Patients

    Seq Age Sex Outcome Treatment
    1 Death