BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID MEDIUM, ALPHA

    MDR report key: 18622871 · Received February 1, 2024

    Report

    Report Number
    1038671-2024-00145
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    January 11, 2024
    Report Date
    January 15, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 5258477-300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM. 5045987-300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S. 4968187-300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. 5131701-310-01-44 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA) 3693545-314-13-03 - EQUINOXE. CAGE GLENOID MEDIUM, ALPHA 5130583-315-35-00 - GLND KWIRE.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF ROTATOR CUFF FAILURE, WHICH MAY HAVE CONTRIBUTED TO THE PROSTHESIS WEAR. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR AND ROTATOR CUFF FAILURE CANNOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2018. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO ROTATOR CUFF FAILURE. THE EQUINOXE ANATOMIC WAS CONVERTED TO AN EQUINOXE REVERSE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420876 EQUINOXE CAGE GLENOID MEDIUM, ALPHA PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention