BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

    MDR report key: 21280213 · Received January 30, 2025

    Report

    Report Number
    1038671-2025-00586
    Event Type
    Injury
    Date Received
    January 30, 2025
    Date of Event
    January 16, 2025
    Report Date
    January 30, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086419
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. D10: 6549850 300-30-11 - EQUINOXE PRESERVE STEM 11MM. 6582017 320-06-42 - GLENOSPHERE 42MM. 6654274 320-15-01 - EQ REV GLENOID PLATE. 6490894 320-15-05 - EQ REV LOCKING SCREW. 6644171 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S101119 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. S068533 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S082462 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S101233 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S103361 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S076381 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 6413273 320-42-00 - 145-DEG PE 42MM HUM LINER +0. 6643716 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT.

    Description of Event or Problem · 0

    \AS REPORTED, APPROXIMATELY 4 YEARS AND 3 MONTHS POST THE INITIAL LEFT SHOULDER ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN. IT IS THE REP'S UNDERSTANDING THAT THE PATIENT FELL. A BURR WAS USED TO OSTEOTOMIZE THE HUMERUS TO REMOVE THE STEM. THE HUMERAL ADAPTER TRAY WAS BROKEN. THERE WAS NO REPORTED 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
    442397 EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086419

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization