BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQINOXE REVERSE COMPRESSION SCREW

    MDR report key: 23528882 · Received November 11, 2025

    Report

    Report Number
    1038671-2025-03326
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 3, 2025
    Report Date
    February 25, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE: (B)(6), 320-15-05 - EQ REV LOCKING SCREW: (B)(6), 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: (B)(6), 320-20-34 - EQ REV COMP SCREW LCK CAP KIT, 4.5 X 34MM: (B)(6), 320-20-34 - EQ REV COMP SCREW LCK CAP KIT, 4.5 X 34MM: (B)(6), 320-20-34 - EQ REV COMP SCREW LCK CAP KIT, 4.5 X 34MM: (B)(6), 320-20-38 - EQ REV COMP SCREW LCK CAP KIT, 4.5 X 38MM: (B)(6), 320-20-38 - EQ REV COMP SCREW LCK CAP KIT, 4.5 X 38MM: (B)(6), 320-20-46 - EQ REV COMP SCREW LCK CAP KIT, 4.5 X 46MM: (B)(6), 322-10-00 - HUMERAL ADAPTER TRAY, +0: (B)(6), 322-42-00 - 145-DEG PE 42MM HUM LINER +0: (B)(6), 531-20-00 - SHLDR GPS RVRS DRILL KIT: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3, H6, H11. ENGINEERING EVALUATION NOTED THE REVISION REPORTED WAS LIKELY THE RESULT OF INSUFFICIENT INITIAL FIXATION OF THE GLENOID BASEPLATE, RESULTING IN BASEPLATE LOOSENING, MIGRATION, AND COMPRESSION SCREW FRACTURE. THE CAUSE OF THE LOOSENING CANNOT BE CONCLUSIVELY DETERMINED, BUT MAY BE RELATED TO THE REPORTED METALOSIS, GLENOID BONE LOSS, AND/OR BONE GRAFT FAILURE. HOWEVER, LOOSENING, MIGRATION, PROSTHESIS FRACTURE, AND THE SERIES OF EVENTS CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 64 YO MALE PATIENT WHO HAD AN INITIAL RIGHT SIDE ANATOMIC SHOULDER REPLACEMENT THAT HAD BEEN REVISED TO A REVERSE DUE TO A POLY BREAK, UNDERWENT A 2ND REVISION PROCEDURE FOR AN UNSTABLE BASE PLATE. DUE TO THE BONE LOSS/LYSIS AND METALOSIS THE BASE PLATE OF THE REVERSE FAILED TO INCORPORATE AND THE BASE PLATE MIGRATED BREAKING 2 BASE PLATE SCREWS. THERE WAS ALSO LYSIS AROUND THE STEM SO EVERYTHING WAS REMOVED AND REPLACED WITH AN ANTIBIOTIC SPACER WHILE A CUSTOM BASEPLATE COULD BE MANUFACTURED. DEVICE BREAKAGE WAS REPORTED AS THE BASE PLATE SCREWS HAD BROKEN. THERE WAS NO SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 4 REPORTS FOR THIS EVENT. THIS IS 1 OF 3 EVENTS FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034302 EQINOXE REVERSE COMPRESSION SCREW PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention