BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 21034614 · Received December 30, 2024

    Report

    Report Number
    1038671-2024-05048
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    December 18, 2024
    Report Date
    December 30, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: A10012 - GPS IMPLANT KIT V2 03000121158,L 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM 5886059, 320-31-36 - GLENOSPHERE, 36MM 6464318, 320-36-00 - 145-DEG PE 36MM HUM LINER +0 6488947,, 320-35-01 - SMALL GLENOID PLATE 6495839 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM 6764234, 320-15-05 - EQ REV LOCKING SCREW 6827652, 531-78-20 - SHOULDR GPS HEX PINS KIT 6873617, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 6876444, 531-20-00 - SHLDR GPS RVRS DRILL KIT 6894356, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S080485, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S081180, 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM S247933.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED IN (B)(6) 2021, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 3 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. TWO REVERSE SCREWS BROKE REQUIRING THE REVISION. THE GLENOID COMPONENTS, LINER, AND TRAY WERE REPLACED. NONE OF THE BROKE PIECES FELL INTO THE PATIENT WOUND SITE. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE SENT TO PATHOLOGY. NO DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2429584 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H11