BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE COMPRESSION SCREW

    MDR report key: 21708479 · Received March 27, 2025

    Report

    Report Number
    1038671-2025-01676
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    June 20, 2023
    Report Date
    March 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY FROM PROTHESIS WEAR OF THE HUMERAL LINER FROM SCAPULAR NOTCHING AND/OR AN INSUFFICIENT BOND BETWEEN THE GLENOID COMPONENT AND BONE LEADING TO ASEPTIC (NON-INFECTED) LOOSENING. FURTHERMORE, THE LOOSENING LIKELY CAUSED THE SCREW FRACTURE DUE TO INCREASED BENDING MOMENTS. HOWEVER, THE CAUSE AND/OR SEQUENCE OF EVENTS CANNOT BE CONFIRMED FROM THE PROVIDED INFORMATION. D10: 5001221153 A10012 - GPS IMPLANT KIT V2 5651064 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM 6484286 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM 6492721 320-15-05 - EQ REV LOCKING SCREW 7002980 320-31-36 - GLENOSPHERE, 36MM 7008863 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 7101420 320-36-03 - 145-DEG PE 36MM HUM LINER +2.5 7141041 531-78-20 - SHOULDR GPS HEX PINS KIT 7170416 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM 7195415 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 7221263 531-20-00 - SHLDR GPS RVRS DRILL KIT S057843 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM S328616 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1 YEAR AND 4 MONTHS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED WITH LOOSENING OF THE GLENOID SIDE COMPONENTS. NO INFECTION WAS PRESENT. THE PATIENT WAS REVISED AND THE SURGEON REMOVED THE GLENOID IMPLANTS, AND PACKED IT WITH BONE GRAFT. THE IMPLANT WAS CONVERTED TO A HEMI AND THE PATIENT WILL REVISIT IN 3 MONTHS TO DETERMINE WHEN A REVERSE CAN BE IMPLANTED. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2416309 EQUINOXE COMPRESSION SCREW PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization SEE H11