BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20286925 · Received September 23, 2024

    Report

    Report Number
    1038671-2024-03664
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    April 18, 2023
    Report Date
    September 23, 2024
    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): 320-46-03 - 145-DEG PE 46MM HUM LINER +2.5: 7150354. 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM: 7238225. 320-08-46 - GLENOSPHERE EXP 46MM +4MM OFFSET: 6580678. 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5: 7218471. 320-15-01 - EQ REV GLENOID PLATE: 7288726. 320-15-05 - EQ REV LOCKING SCREW: 7304942. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 7294567. 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM: S337395. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: S354750. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: S354790. 315-35-00 - GLND KWIRE: 7289378. 321-52-07 - 3.2MM DRILL BIT STERILE: 6562949. 531-78-20 - SHOULDR GPS HEX PINS KIT: 7312131. A10012 - GPS IMPLANT KIT V2: 08000321102. A10012 - GPS IMPLANT KIT V2: 11018421021.

    Description of Event or Problem · 0

    APPROXIMATELY 11 MONTH(S) AND 15 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISLOCATION. PATIENT UNABLE TO EXPLAIN THE NOISE COMING FROM THE RIGHT SHOULDER. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION, IN WHICH THE STANDARD HUMERAL STEM, HUMERAL TRAY, HUMERAL LINER AND GLENOSPHERE WERE REMOVED. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869192 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male SEE H11