BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID MEDIUM, ALPHA

    MDR report key: 19246503 · Received May 6, 2024

    Report

    Report Number
    1038671-2024-01057
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    April 11, 2024
    Report Date
    March 24, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862172686
    PMA / PMN Number
    K113309
    Removal / Correction Number
    Z-1412-2024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 3682403 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM. 3951264 310-01-44 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA). 4130549 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. 4153578 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. 4173877 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. THE REVISION REPORTED WAS LIKELY DUE TO GLENOID COMPONENT WEAR. ADDITIONAL REASONS FOR THE REVISION INCLUDE AN INSUFFICIENT BOND BETWEEN THE GLENOID COMPONENT AND THE BONE AND THE HUMERAL COMPONENT AND THE BONE LEADING TO GLENOID AND HUMERAL LOOSENING RESPECTIVELY, POSSIBLE FRACTURE OF THE SUPERIOR EDGE OF THE GLENOID COMPONENT, AND/OR THE INCLUSION OF THE GLENOID COMPONENT IN THE PACKAGING RECALL. HOWEVER, THESE CANNOT BE CONFIRMED FROM THE PROVIDED INFORMATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WAS REVISED ON (B)(6) 2024. ALL THE COMPONENTS WERE LOOSE AND EASILY REMOVED. ARTHREX REVERSE WAS THEN PERFORMED AFTER BONE GRAFTING THE DEFECTS. NO ISSUES WITH SURGERY. EXPLANTS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764175 EQUINOXE CAGE GLENOID MEDIUM, ALPHA PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK 10885862172686

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention