BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19155764 · Received April 22, 2024

    Report

    Report Number
    1038671-2024-00929
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    March 29, 2024
    Report Date
    June 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086709
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 7085596 - 300-30-14 - EQUINOXE PRESERVE STEM 14MM. A620259 - 320-06-42 - GLENOSPHERE 42MM. A797142 - 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5. A131404 - 320-15-04 - RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT. A610024 - 320-15-05 - EQ REV LOCKING SCREW. A560891 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. A737215 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. A737229 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. A737235 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. S492917 - 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. S488029 - 320-42-03 - 145-DEG PE 42MM HUM LINER +2.5. S448092 - 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK. A789082 - 531-55-88 - ERGO GPS 3.2MM DRILL KIT STERILE. A677253 - 531-78-20 - SHOULDR GPS HEX PINS KIT. 7025123305 - A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE PATIENT¿S SHOULDER INSTABILITY AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. INSTABILITY IS A KNOWN RISK, AS OUTLINED IN THE IFU.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO INSTABILITY AND A NEW LINER AND TRAY WERE IMPLANTED. NO ISSUES. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035114 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK 10885862086709

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H10.