BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 18109260 · Received November 10, 2023

    Report

    Report Number
    1038671-2023-02737
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    October 2, 2023
    Report Date
    July 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: (B)(6), 300-30-08 - EQUINOXE PRESERVE STEM 8MM. (B)(6), 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6990310 320-06-38 - GLENOSPHERE 38MM. (B)(6), 320-15-03 - RS GLENOID PLATE L POST AUG, 8 DEG, LEFT.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2021. THE PATIENT PRESENTED ON (B)(6) 2023 AND PATIENT DISLOCATED SHOULDER WHILE SLEEPING, SEEN IN ED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE, DEFINITELY NOT RELATED TO PROCEDURE. OUTCOME: RESOLVED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867016 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10