BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20332851 · Received September 30, 2024

    Report

    Report Number
    1038671-2024-03735
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    September 12, 2024
    Report Date
    June 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 02000624293 A10012 - GPS IMPLANT KIT V2, A805335 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM, A934599 300-30-07 - EQUINOXE PRESERVE STEM 7MM, A971111 320-15-05 - EQ REV LOCKING SCREW, B002620 322-42-00 - 145-DEG PE 42MM HUM LINER +0, B022229 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM, B031817 320-06-42 - GLENOSPHERE 42MM, B035736 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, B040305 320-15-01 - EQ REV GLENOID PLATE, B046065 531-78-20 - SHOULDR GPS HEX PINS KIT, B050699 322-10-00 - HUMERAL ADAPTER TRAY, +0, B068921 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT, B084047 531-20-00 - SHLDR GPS RVRS DRILL KIT, S509709 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM.

    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.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 MONTHS POST THE INITIAL RIGHT TSA, THE PATIENT DEVELOPED AND INFECTION AND WAS REVISED. ALL IMPLANTS WERE REMOVED, CULTURES TAKEN, AND AN ANTIBIOTIC SPACER AND BEADS WERE IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040388 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention SEE H11