BEUDAMED
    FDA Adverse Event Death Summary report: N

    EQUINOXE

    MDR report key: 11881821 · Received May 25, 2021

    Report

    Report Number
    1038671-2021-00251
    Event Type
    Death
    Date Received
    May 25, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 3, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862083395
    PMA / PMN Number
    K092900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (DEVICE EVALUATED BY MFR) UPON REVIEW OF THIS EVENT, IT IS FOUND NOT TO MEET THE DEFINITION OF A COMPLAINT, AS THERE IS NO ALLEGED DEFICIENCIES RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE. THERE IS NO REASONABLE CAUSALITY BETWEEN THE DEVICE IN THE EQUINOXE SHOULDER SYSTEM (304-22-09) TO THE DEATH OF THE PATIENT DUE TO A ¿A TENSION DROP & INCREASE OF CO2 WITHOUT ANY EXPLANATION JUST 20 MINUTES INTO THE PROCEDURE¿. THE PROCEDURE AND SUBSEQUENT DEATH WAS 1 WEEK AFTER THE TRAUMA TO THE SHOULDER. IT¿S NOT EXACTLY KNOWN HOW FAT EMBOLI AND SUBSEQUENT FES OCCUR, BUT ONE LEADING GUESS IS THE ¿MECHANICAL OBSTRUCTION THEORY.¿ THE IDEA BEHIND THIS THEORY IS THAT WHEN LARGE BONES BREAK, FAT FROM THE BONE MARROW, WHICH IS MADE UP OF FATTY CELLS, SEEPS INTO THE BLOODSTREAM. THIS FAT CREATES CLOTS (FAT EMBOLI) THAT OBSTRUCT BLOOD FLOW ¿ OFTEN IN THE LUNGS. THESE EMBOLI ALSO PRODUCE WIDESPREAD INFLAMMATION (1). THE PATIENT REPORTED NO CO-MORBIDITIES, OTHER THAN THE PREVIOUS SHOULDER (HUMERAL HEAD) TRAUMA, THAT LEND THEMSELVES TO CIRCULATORY EMBOLI, SPECIFICALLY DEEP VEIN THROMBOSIS (DVT) OR FAT EMBOLUS. AT THIS TIME, THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PATIENT¿S CONDITIONS. OUT OF AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 310-01-47, 6687927 - EQUINOXE, HUMERAL HEAD SHORT, 47MM (BETA); 300-21-00, 6720325 - 0MM FIXED ANGLED KIT.

    Description of Event or Problem · 1

    AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT WITH NO PREVIOUS MEDICAL HISTORY, APPROXIMATELY 1 WEEK BEFORE SUFFERED A SHOULDER TRAUMA (HUMERAL HEAD) AND WAS UNDERGOING PROCEDURE FOR REPAIR. APPROXIMATELY 20 MINUTES AFTER THE PROCEDURE BEGAN, THE PATIENT EXPERIENCED A TENSION DROP & INCREASE OF CO2 WITHOUT ANY EXPLANATION. THE SURGEON WAS THEN INSERTING SUTURE WIRES INTO THE TUBEROSITIES SO THAT HE COULD FIX THEM AFTER THE IMPLANTATION OF THE STEM. THE IMPLANT WAS NOT YET PLACED AND THERE WAS NO CEMENT USED AT THIS TIME. THERE WAS HEART MASSAGE WITH DEFIBRILLATOR. ¿PATIENT CAME BACK¿ FINALLY SO THE ANATOMIC FX SHOULDER HAS BEEN IMPLANTED. AT THE END OF PROCEDURE, THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT AND DIED AFTERWARDS WITHIN THE DAY. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED AT THIS TIME. IT WAS REPORTED THAT THE IMPLANT WAS NOT THE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771828 EQUINOXE 8.5MM PLATFORM FX STEM RIGHT KWT EXACTECH, INC. 304-22-09 UNK 10885862083395

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death