BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOX

    MDR report key: 10458665 · Received August 27, 2020

    Report

    Report Number
    1038671-2020-00505
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    August 12, 2020
    Report Date
    October 27, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086419
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (H3): THE REVISION DUE TO DISLOCATION REPORTED WAS MOST LIKELY THE RESULT OF INSUFFICIENT TENSIONING IN THE JOINT AND SUBSEQUENT INSTABILITY. THE REVISION OF ALL HUMERAL SIDE COMPONENTS WAS LIKELY THE RESULT OF EXCESS CEMENT RESULTING IN THE MODULAR COMPONENTS BECOMING ADHERED TOGETHER. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 300-01-07, 6150215 - EQUINOXE HUMERAL STEM PRIMARY 7MM, 320-38-10, 5870262 - EQUINOXE REVERSE SHOULDER LINER 38MM +0, 320-01-38, 6320049 - EQUINOXE REVERSE 38MM GLENOSPHERE, 320-15-05, 6490896 - EQUINOXE REVERSE SHOULDER GLENOSPHERE LOCKING SCREW, 315-35-00, 5160934 - GLND KWIRE, 321-20-00, 5241024 - EQUINOXE REVERSE SHOULDER DRILL KIT, 320-15-01, 5497446 - EQUINOXE REVERSE GLENOID PLATE, 320-20-00, 6527741 - EQUINOXE REVERSE TORQUE DEFINING SCREW KIT, 320-20-30, 5553362 - EQUINOXE REVERSE COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, 320-20-30, 5551326 - EQUINOXE REVERSE COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, 320-20-30, 5552922 - EQUINOXE REVERSE COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM.

    Description of Event or Problem · 1

    AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT EXPERIENCED A DISLOCATION ONE (1) DAY AFTER THE INITIAL IMPLANT OF THE LEFT TSA. THE DISLOCATION WAS DUE TO THE JOINT BEING TOO LOOSE. HUMERAL IMPLANTS CAME OUT DUE TO ANTIBIOTIC CEMENT HOLDING IT TOGETHER IN HUMERAL CANAL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WERE DISPOSED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923710 EQUINOX REVERSE TRAY ADAPTER PLATE TRAY +0 KWT EXACTECH, INC. 320-10-00 UNK 10885862086419

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R SEE H10.