BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID MEDIUM, ALPHA

    MDR report key: 20072414 · Received August 26, 2024

    Report

    Report Number
    1038671-2024-03090
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    August 8, 2024
    Report Date
    April 24, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862172686
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM: 6850907. 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S: 6729931. 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT: 6926508. 310-02-44 - EQUINOXE, HUMERAL HEAD TALL, 44MM (ALPHA): 6522283. 531-78-20 - SHOULDR GPS HEX PINS KIT: 6954723. A10012 - GPS IMPLANT KIT V2: 02055321242.

    Additional Manufacturer Narrative · 0

    NO MANUFACTURING PROCESS-RELATED NON-CONFORMANCES, DEVIATIONS, OR EXCEPTIONS ARE ASSOCIATED WITH THIS ANATOMIC CAGE GLENOID. THEREFORE, THIS DOES NOT APPEAR TO BE MANUFACTURING RELATED. USER-RELATED CONSIDERATIONS: THERE WERE NO USER-RELATED ISSUES REPORTED THAT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED EVENT. PATIENT-RELATED CONSIDERATIONS: THERE ARE NO PATIENT CONDITIONS REPORTED THAT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF FRACTURE. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3 YEARS AND ONE MONTH POST THE INITIAL RIGHT TSA, THE PATIENT WAS REVISED DUE TO THE CENTER CAGE DISASSOCIATING FROM THE POLYETHYLENE GLENOID. THE GLENOID WAS BONE GRAFTED AND THE STEM REMOVED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882271 EQUINOXE CAGE GLENOID MEDIUM, ALPHA PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862172686

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention SEE H11