BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID L, POST AUG, RIGHT

    MDR report key: 19264127 · Received May 7, 2024

    Report

    Report Number
    1038671-2024-01105
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 12, 2024
    Report Date
    September 24, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862201027
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 4091614 310-01-50 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA) 4180222 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S 4231957 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT 4286530 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: G3, H6, H11. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. THE REVISION MAY BE THE RESULT OF GLENOID LOOSENING THAT RESULTED IN CENTER CAGE FRACTURE AND PROSTHESIS WEAR. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS FROM USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED FROM THE REPORTED 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

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2016. THE PATIENT WAS REVISED ON (B)(6) 2024; REASON NOT REPORTED. THE PATIENT WAS REVISED TO AN HRP WITH A +10 EXT CAGE BASEPLATE WITH A FEMORAL HEAD STRUCTURAL ALLOGRAFT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621737 EQUINOXE CAGE GLENOID L, POST AUG, RIGHT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862201027

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention SEE H10