BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 38MM GLENOSPHERE

    MDR report key: 17640866 · Received August 29, 2023

    Report

    Report Number
    1038671-2023-02069
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    June 20, 2023
    Report Date
    January 6, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086389
    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): EQ REV GLENOID PLATE, 320-15-01 ,6234160. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, 320-20-30, 6241389. EQ REV LOCKING SCREW 320-15-05 6217896 EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM, 320-20-34 6239591. EQUINOXE, HUMERAL LONG STEM 8MM 175MM ,306-01-08 ,3786648. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 320-10-00 ,6257804. EQ REVERSE TORQUE DEFINING SCREW KIT, 320-20-00, 6237635. EQUINOXE REVERSE 38MM HUMERAL LINER +0, 320-38-00, 6218754.

    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 DISLOCATION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND THE RESULT OF LOOSENED SUPPORTING LIGAMENTS AND MUSCLES, WHICH ALLOWED FOR DISLOCATION OCCURRING DUE TO THE SIGNIFICANT LIGAMENT RE-CONSTRUCTION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (G2) REPORT SOURCE - COMPANY REPRESENTATIVE SHOULD HAVE BEEN CHECKED (G4) DATE RECEIVED BY MANUFACTURER ¿ DATE ON FINAL SUBMISSION SHOULD HAVE BEEN (16-DEC-2023 (G6) TYPE OF REPORT - 30-DAY SHOULD HAVE BEEN CHECKED ALONG WITH FOLLOW-UP.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL LEFT TKA, THIS 88 Y/O FEMALE PATIENT WAS REVISED DUE TO DISLOCATION. GLENOSPHERE AND LINER WERE EXCHANGED TO EXPANDED 38MM GLENOSPHERE AND +2.5 CONSTRAINED LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING - DISPOSED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729516 EQUINOXE REVERSE 38MM GLENOSPHERE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862086389

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Hospitalization| R SEE H10