BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19962814 · Received August 12, 2024

    Report

    Report Number
    1038671-2024-02784
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    August 28, 2023
    Report Date
    July 25, 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

    CONCOMITANT DEVICE(S): 320-38-00 - 145-DEG PE 38MM HUM LINER +0: (B)(6), 300-30-13 - EQUINOXE PRESERVE STEM 13MM: (B)(6), 320-08-38 - GLENOSPHERE EXP 38MM +4MM OFFSET: (B)(6), 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: (B)(6), 320-15-03 - RS GLENOID PLATE L POST AUG, 8 DEG, LEFT: (B)(6), 315-35-00 - GLND KWIRE: (B)(6), 320-15-05 - EQ REV LOCKING SCREW:(B)(6), 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: (B)(6), 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM: (B)(6), 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: (B)(6), 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: (B)(6), 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: (B)(6), A10012 - GPS IMPLANT KIT V2: (B)(6), EXC-EQRV38-US - ORTHOSENSOR 38MM USA: (B)(6).

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE POST OPERATIVE BONE FRACTURE REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO IMPLANT POSITIONING, PATIENT BONE QUALITY, A TRAUMA, AND/OR ANOTHER PATIENT RELATED CONDITION. HOWEVER, THIS CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    APPROXIMATELY 2 MONTH(S) AND 2 DAY(S) POST-OPERATIVE OF A LEFT TSA, THE PATIENT PRESENTED WITH A SCAPULAR SPINE FRACTURE (TYPE 2). PATIENT DROPPED A PACK OF WATER AND HAD IMMEDIATE PAIN IN THE LEFT ACROMION AREA. THE PATIENT WAS ORDERED A CT SCAN, AND THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING. 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
    1844383 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male SEE H11