BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID SMALL, ALPHA

    MDR report key: 19185842 · Received April 25, 2024

    Report

    Report Number
    1038671-2024-00986
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    April 1, 2024
    Report Date
    August 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862172679
    PMA / PMN Number
    K113309
    Removal / Correction Number
    Z-1412-2024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4356081 - 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM 2683993 - 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S 4177450 - 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT 3951189 - 310-01-41 - EQUINOXE, HUMERAL HEAD SHORT, 41MM (ALPHA) 3868642 - 314-13-02 - EQUINOXE CAGE GLENOID SMALL, ALPHA 4333994 - 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT H3:THE REVISION REPORTED WAS LIKELY THE RESULT OF FRACTURE OF THE IMPLANT. THE CAUSE OF FRACTURE IS GENERALLY A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: G1, H6 MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS FRACTURE OF THE GLENOID COMPONENT. THE CAUSE OF THE FRACTURE COULD HAVE BEEN DUE TO IMPROPER INITIAL SEATING OF THE GLENOID AND/OR DUE TO OFF-AXIS DRILLING OF THE PERIPHERAL PEGS RESULTING IN A ROCKING HORSE MOTION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INITIAL POST-OPERATIVE RADIOGRAPHS WERE NOT PROVIDED. 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

    AS REPORTED, THE 77 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6)2016. THE PATIENT WAS REVISED ON (B)(6)2024 DUE TO A FAILED GLENOID/DISASSOCIATION. 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
    856498 EQUINOXE CAGE GLENOID SMALL, ALPHA PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862172679

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE H10.