BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19630124 · Received June 27, 2024

    Report

    Report Number
    1038671-2024-02198
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    June 7, 2024
    Report Date
    July 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086617
    PMA / PMN Number
    K093275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 320-31-36 - GLENOSPHERE, 36MM: 6677425, 320-36-00 - 145-DEG PE 36MM HUM LINER +0: 6555478, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 6758888, 320-15-05 - EQ REV LOCKING SCREW: 6749251, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6738080, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: S103174, 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: S213774, 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM: S123484, 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 6785071.

    Additional Manufacturer Narrative · 0

    D1: CORRECTED D4/D6: DEVICE, SERIAL #, UDI #, EXPIRATION, IMPLANT AND EXPLANT DATES UNKNOWN. G3: MANUFACTURED DATES UNKNOWN. G4: PMA 510K CANNOT BE DETERMINED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    APPROXIMATELY 1 YEAR, 7 MONTHS. AND 7 DAYS AFTER AN INITIAL LEFT TSA, THE PATIENT DISLOCATED THE SHOULDER DUE TO RECURRENT INSTABILITY EPISODES OVER 2 YEARS. 3 YEARS AND 5 MONTHS AFTER INITIAL IMPLANTATION, THE PATIENT UNDERWENT STANDARD REVERSE WITH PRESERVE STEM REVISION AND THE EVENT IS CONSIDERED RESOLVED. THE CASE REPORT INDICATES THAT THE EVENT IS POSSIBLY RELATED TO DEVICE(S) AND/OR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820806 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086617

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female SEE H11.