BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

    MDR report key: 17640798 · Received August 29, 2023

    Report

    Report Number
    1038671-2023-02066
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    June 25, 2023
    Report Date
    February 24, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086419
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): A000198 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM. A042970 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 6553221 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG. A000846 320-15-05 - EQ REV LOCKING SCREW. A014336 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S361952 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. S364980 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S365872 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S366135 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. A001731 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0. A003148 531-20-00 - SHLDR GPS RVRS DRILL KIT. A005939 531-78-20 - SHOULDR GPS HEX PINS KIT. 2026522162 A10012 - GPS IMPLANT KIT V2. A042970 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0.

    Additional Manufacturer Narrative · 0

    SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D1) BRAND NAME: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 (D4) CATALOG NUMBER: 320-10-00, SERIAL NUMBER: (B)(6), UNIQUE IDENTIFIER (UDI) #: (B)(4), IF EXPLANTED, GIVE DATE: (B)(6) 2023 (D10) CONCOMITANT DEVICE(S): (B)(6) - EQUINOXE REVERSE 42MM HUMERAL LINER +(B)(6) - EQ REVERSE TORQUE DEFINING SCREW KIT (H4) DEVICE MANUFACTURE DATE: (B)(6) 2022

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED MALFUNCTION AND THERE IS NO ALLEGATION AGAINST THE DEVICE. IMPLANTATION OF A TOTAL JOINT COULD RESULT SCAPULAR NOTCHING AND DISLOCATION. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PATIENT CONDITIONS.

    Additional Manufacturer Narrative · 0

    SECTION H10: (G2) REPORT SOURCE - COMPANY REPRESENTATIVE SHOULD HAVE BEEN CHECKED (G4) DATE RECEIVED BY MANUFACTURER ¿ DATE ON FINAL SUBMISSION SHOULD HAVE BEEN 15-DEC-2023 (G6) TYPE OF REPORT - 30-DAY SHOULD HAVE BEEN CHECKED ALONG WITH FOLLOW-UP

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1 YEAR POST OP INITIAL LEFT TSA, THIS MALE PATIENT WAS REVISED DUE TO DISLOCATION. YES THE ADAPTER TRAY WAS EXCHANGED TO A +5MM TRAY. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE INSTABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY WAS REPORTED. UNABLE TO OBTAIN PHOTOS/X-RAYS. PRODUCT NOT RETURNING - DISPOSED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2101939 EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862086419

    Patients

    Seq Age Sex Outcome Treatment
    1 Male SEE H10