BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID XL, POST AUG, RIGHT

    MDR report key: 19571195 · Received June 19, 2024

    Report

    Report Number
    1038671-2024-02026
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    June 6, 2024
    Report Date
    November 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862201034
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 5184510 300-01-15 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM. 5131398 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. 5169595 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. 5119250 310-01-50 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA). 08012017028 A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 65 Y/O MALE PATIENT'S RIGHT SHOULDER HAD A LOOSE ANATOMIC GLENOID COMPONENT EXTRACTED APPROXIMATELY 6 YEARS 5 MONTHS POST OP INITIAL SURGERY. FRAGMENTS, PARTS AND/OR PIECES FELL INTO THE PATIENT AND WERE REMOVED. PARTS AND/OR PIECES OF THE DEVICE FELL INTO THE PATIENT WOUND SITE. THOSE PARTS AND/OR PIECES WERE REMOVED FROM THE PATIENT: LOOSE ANATOMIC GLENOID WAS EXTRACTED. THE REPORTED EVENT DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762691 EQUINOXE CAGE GLENOID XL, POST AUG, RIGHT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862201034

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male SEE H11