BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12821224 · Received November 16, 2021

    Report

    Report Number
    1038671-2021-00620
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    October 26, 2021
    Report Date
    May 10, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION . CONCOMITANT DEVICE(S): 320-15-04, 6965886 - RS GLENOID PLATE POST AUG, 8 DEG, RIGHT, 320-15-05, 7064167 - EQ REV LOCKING SCREW 320-01-38, 6745107 - EQUINOXE REVERSE 38MM GLENOSPHERE, 320-20-00, 7005342 - EQ REVERSE TORQUE DEFINING SCREW KIT, 320-10-00, 7022841 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 300-01-11, 7000134 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM.

    Additional Manufacturer Narrative · 0

    (H3) UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED MALFUNCTION AND THERE IS NO ALLEGATION AGAINST THE DEVICE. IMPLANTATION OF A TOTAL JOINT COULD RESULT SCAPULAR NOTCHING AND DISLOCATION. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PATIENT CONDITIONS.

    Description of Event or Problem · 0

    AS REPORTED, THE FEMALE PATIENT DISLOCATED RIGHT SHOULDER ON 1ST POST-OP DAY, PATIENT WAS REVISED THE FOLLOWING DAY WITH A LINER CHANGE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT THE DEVICE WAS DISPOSED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720103 EQUINOXE REVERSE 38MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-38-00 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention| H