BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 16910094 · Received May 11, 2023

    Report

    Report Number
    1038671-2023-00965
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    March 21, 2023
    Report Date
    October 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086662
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 4889713 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM. 4804237 315-35-00 - GLND KWIRE. 4917471 315-35-00 - GLND KWIRE. 5068769 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE. 5092937 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 5014300 320-15-04 - RS GLENOID PLATE POST AUG, 8 DEG, RIGHT. 4957307 320-15-05 - EQ REV LOCKING SCREW. 5075494 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. 4923453 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 4988872 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 5012648 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 4550033 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. 8011017076 A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INSTABILITY AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL RIGHT TSA, THIS 68 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. GLENOSHERE, LOCKING SCREW , LINER , ADAPTER TRAY AND TORQUE SCREW WERE CHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. UNABLE TO OBTAIN X-RAYS/PHOTOS. PRODUCT NOT RETURNING - DISPOSED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864253 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862086662

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H SEE H10