BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19963015 · Received August 12, 2024

    Report

    Report Number
    1038671-2024-02785
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    April 24, 2024
    Report Date
    March 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION: PLEASE DISREGARD THIS REPORT AS IT WAS SUBMITTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT # 1038671-2024-02581.

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE(S): 320-42-00: 145-DEG PE 42MM HUM LINER +0: S341634. 300-30-08: EQUINOXE PRESERVE STEM 8MM: 7251167. 320-08-42: GLENOSPHERE EXP 42MM +4MM OFFSET: 7323652. 320-10-00: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: A057263. 320-15-01: EQ REV GLENOID PLATE: A005242. 320-15-05: EQ REV LOCKING SCREW: 7313068. 320-20-00: EQ REVERSE TORQUE DEFINING SCREW KIT: 7294592. 320-20-18: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM: A051246. 320-20-22: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: S286988. 320-20-22: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: S287434. 320-20-26: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: S366818. A10012: GPS IMPLANT KIT V2: 10099121367. EXC-EQRV42-US: ORTHOSENSOR 42MM USA: 562760059.

    Description of Event or Problem · 0

    APPROXIMATELY 1 YEAR(S), 9 MONTH(S) AND 0 DAY(S) POST-OPERATIVE OF A RIGHT TSA, THE PATIENT PRESENTED WITH A TYPE 1 ACROMIAL FRACTURE. THE PATIENT DENIES ANY TRAUMATIC EVENTS. STARTED OVER TIME: PAIN WAS WORSENING AND THEN HAD MUCH GREATER PAIN ABOUT 1-2 WEEKS AGO WITH DIFFUSE ECCHYMOSIS ACROSS SHOULDER REGION. PAIN CAN BE MODERATE TO SEVERE. THERE WERE NO DIRECT ACTIONS TAKEN ON THE PATIENT¿S BEHALF AND THE OUTCOME OF THIS EVENT IS REPORTED AS RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779580 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male