BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20397069 · Received October 8, 2024

    Report

    Report Number
    1038671-2024-03847
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 20, 2024
    Report Date
    June 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): A10012 - GPS IMPLANT KIT V2, 03020824205; 320-40-03 - 145-DEG PE 40MM HUM LINER +2.5, A761542; 531-78-20 - SHOULDR GPS HEX PINS KIT, A786959; 320-35-02 - SMALL SUPERIOR AUGMENT GLENOID PLATE, A899340; 300-30-11 - EQUINOXE PRESERVE STEM 11MM, A976958; 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, B026471; 322-10-00 - HUMERAL ADAPTER TRAY, +0, B029933; 320-31-40 - GLENOSPHERE, 40MM, B052794; 320-15-05 - EQ REV LOCKING SCREW, B057561; 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT, B059446; 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM, S104476; 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM, S327588; 320-20-22 - EQ REV COMPRESS S.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT HAD AN ORIGINAL EXACTECH REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA) ON THEIR RIGHT SIDE. POST OPERATIVELY THE PATIENT WAS NOT WEARING THEIR ARM/SHOULDER SLING WHILE SIMULTANEOUSLY PERFORMING MOTIONS WITH THEIR SHOULDER THAT IS OUT OF THE RANGE AND NON-COMPLIANT TO THE POST OPERATIVE INSTRUCTIONS. THE PATIENT SUBSEQUENTLY DISLOCATED THEIR REVERSE SHOULDER COMPONENTS. THE JOINT WAS CLOSED REDUCED HOWEVER THE PATIENT HAS CONTINUED TO DISLOCATION THEIR SHOULDER JOINT. THE PATIENT WAS SCHEDULED FOR A REVISION RIGHT RTSA WITH GLENOSPHERE LATERALIZATION AND CONSTRAINED LINER PLACEMENT. THE PATIENT'S SHOULDER IMPLANTS WERE CONVERTED TO A LATERALIZED 40 GLENOSPHERE, A +5MM HUMERAL TRAY, AND A +0 CONSTRAINED HUMERAL LINER. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22463 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11