BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 18179104 · Received November 20, 2023

    Report

    Report Number
    1038671-2023-02823
    Event Type
    Injury
    Date Received
    November 20, 2023
    Date of Event
    October 19, 2023
    Report Date
    June 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 6813673 300-30-06 - EQUINOXE PRESERVE STEM 6MM , A483954 320-06-42 - GLENOSPHERE 42MM , A477015 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 , A132747 320-15-03 - RS GLENOID PLATE L POST AUG, 8 DEG, LEFT A425238 320-15-05 - EQ REV LOCKING SCREW , A415651 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A061650 320-20-34 - EQ REV COMPRESS, SCREW LCK CAP KIT, 4.5 X 34MM , S390821 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM , S373879 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM , S419807 320-42-00 - 145-DEG PE 42MM HUM LINER +0 , A240742 321-52-10 - 3.2MM K-WIRE, THD, SHORT 2 K-WIRES PER PACK A366414 531-55-88 - ERGO GPS, 3.2MM DRILL KIT STERILE , A366156 531-78-20 - SHOULDR GPS HEX PINS KIT , 11000222105 A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    H3: A REVIEW OF THE STERILE CERTIFICATES AND/OR THE FINAL ENDOTOXIN TEST REPORTS WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR THE SURGICAL PROCEDURE. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: THE FOLLOWING SECTIONS WERE CORRECTED: D1, D2A, D2B, REMOVE INFORMATION FROM D4: CATALOG NUMBER, EXPIRATION DATE, SERIAL NUMBER, AND UDI#, D7A, REMOVE INFORMATION FROM G4: 510(K), REMOVE INFORMATION FROM H4: DEVICE MANUFACTURE DATE, H6 CLINICAL CODE AND COMPONENT CODE.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2023 . OVER TIME THE PATIENT BECAME INFECTED AND WAS WASHED OUT AND REVISED ON (B)(6) 2023 . 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720046 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention