BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

    MDR report key: 19892394 · Received August 2, 2024

    Report

    Report Number
    1038671-2024-02648
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    January 28, 2024
    Report Date
    August 2, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-30-08 - EQUINOXE PRESERVE STEM 8MM: 7251192. 320-42-00 - 145-DEG PE 42MM HUM LINER +0: A001613. 320-06-42 - GLENOSPHERE 42MM: 6695708. 320-15-03 - RS GLENOID PLATE L POST AUG, 8 DEG, LEFT: 7097355. 320-15-05 - EQ REV LOCKING SCREW: 7328425. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: A005049. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: S316691. 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: 5891712. 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: 7024315. 531-78-20 - SHOULDR GPS HEX PINS KIT: 7311956. 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS: 315590. 620-12-02 - ACCELERATE PRP 60 ML & ACD-A: A20220001. A10012 - GPS IMPLANT KIT V2: 12000621028.

    Description of Event or Problem · 0

    APPROXIMATELY 2 YEAR(S), 1 MONTH(S) AND 17 DAY(S) POST-OPERATIVE OF A LEFT TSA, THE PATIENT PRESENTED WITH BREAKAGE OF A COMPONENT (SCREWS, STEM, ETC.) - FAILED/BROKEN HUMERAL ADAPTER TRAY. THE PATIENT UNDERWENT STANDARD REVERSE WITH PRESERVE STEM REVISION, AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND DID NOT INDICATE ANY RELATION TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985081 EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male SEE H11