BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 42MM HUMERAL LINER +0

    MDR report key: 19516163 · Received June 11, 2024

    Report

    Report Number
    1038671-2024-01908
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    July 30, 2020
    Report Date
    January 14, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET: 5335144. 320-15-05 - EQ REV LOCKING SCREW: 6113806. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6274444.

    Description of Event or Problem · 0

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 0 YEAR(S) AND 5 MONTH(S) POST IMPLANTATION OF LEFT REVISED TSA (REVISION REPORTED ON (B)(4)THE PATIENT PRESENTED WITH DISASSOCIATION OF POLYETHYLENE - STANDARD REVERSE. THIS OUTCOME OF THE EVENT WAS RESOLVED BY STANDARD REVERSE REVISION OF THE LEFT SHOULDER. THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND DEFINITELY NOT RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373106 EQUINOXE REVERSE 42MM HUMERAL LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male SEE H11