BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 18576347 · Received January 24, 2024

    Report

    Report Number
    1038671-2024-00127
    Event Type
    Injury
    Date Received
    January 24, 2024
    Date of Event
    December 26, 2023
    Report Date
    October 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    UDI-DI
    10885862580405
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: A641424 300-30-06 - EQUINOXE PRESERVE STEM 6MM. A781399 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. A562951 320-15-05 - EQ REV LOCKING SCREW. A652595 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S479699 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. A758168 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. A737718 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. S277091 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM. A353661 320-31-40 - GLENOSPHERE, 40MM. A656268 320-35-07 - SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE,LEFT. 7241820 320-40-00 - 145-DEG PE 40MM HUM LINER +0. A769138 321-52-09 - 3.2MM K-WIRE, TROCAR TIP. A595664 321-52-10 - 3.2MM K-WIRE, THD, SHORT 2 K-WIRES PER PACK. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6), 2023. DURING THE COURSE OF THE INITIAL SURGERY, THE HUMERAL HEAD PROTECTOR DISASSOCIATED FROM THE TRIAL PRESERVE STEM. THE EVENT WAS NOT NOTICED. THE DISASSOCIATED HUMERAL HEAD PROTECTOR MOVED POSTERIOR TO THE GLENOID AND WAS THEREFORE NOT VISIBLE FROM THE INCISION. THE SURGERY WAS COMPLETED SUCCESSFULLY, HOWEVER THE DEVICE COMPONENT REMAINED IN THE SHOULDER WHICH THE SURGEON BECAME AWARE OF DURING A REVIEW OF POST OPERATIVE X-RAYS. THERE WAS AN INSTRUMENT COUNT COMPLETED PRIOR TO WOUND CLOSURE, BUT THIS INSTRUMENT WAS NOT INCLUDED IN THE COUNT. THE REVISION SURGERY WAS COMPLETED TO REMOVE THE INSTRUMENT. THE GLENOSPHERE, TRAY, AND LINER WERE EXCHANGED, AND THE HUMERAL HEAD PROTECTOR WAS SUCCESSFULLY REMOVED. REMOVING THE DEVICE CAUSED A GREATER THAN 45-MINUTE SURGICAL DELAY/PROLONGATION DURING THE PROCEDURE. THERE WAS NO ADVERSE EVENT TO THE PATIENT AS A RESULT. NO PATIENT INFORMATION, X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191438 EQUINOXE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH EXACTECH, INC. SMALL STEM PROTECTOR 285700027 10885862580405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10