BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20007381 · Received August 20, 2024

    Report

    Report Number
    1038671-2024-02910
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    August 6, 2024
    Report Date
    October 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 5053378 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0. 5109143 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE. 5083225 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 5084191 320-15-01 - EQ REV GLENOID PLATE. 4969481 320-15-05 - EQ REV LOCKING SCREW. 5049534 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 4969348 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 4739241 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. 5083527 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. 5103863 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 6 YEARS AND 8 MONTHS POST THE INITIAL LEFT TSA, THE PATIENT WAS REVISED DUE TO THE TORQUE DEFINING SCREW GETTING STUCK INSIDE THE TRAY/STEM. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153187 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention SEE H11