BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID LARGE, BETA

    MDR report key: 19662545 · Received July 2, 2024

    Report

    Report Number
    1038671-2024-02289
    Event Type
    Injury
    Date Received
    July 2, 2024
    Report Date
    February 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862172716
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-62-03 - STEMLESS HUMERAL COMP INTEGRIP, CAGE, SIZE 3 5990284; 310-60-53 - STEMLESS HUMERAL HEAD EXTRA SHORT, 53MM (BETA) 5768035; 319-01-32 - STEINMANN PIN STERILE 3.2MM X 178MM 5565529.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE GLENOID COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) GLENOID LOOSENING. POTENTIAL CONTRIBUTIONS OF USER-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. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    APPROXIMATELY 4 YEAR(S), 11 MONTH(S), AND 14 DAY(S) POST-OPERATIVE OF A RIGHT TSA, THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING FOR ABOUT 1 MONTH WITHOUT INJURY. A JOINT OPERATION AND CT SCAN ARE SCHEDULED, THE EVENT IS CONTINUING, AND THE DEVICE(S) REMAIN IMPLANTED. THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND UNLIKELY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579433 EQUINOXE CAGE GLENOID LARGE, BETA PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862172716

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male SEE H11.