BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID MEDIUM, ALPHA

    MDR report key: 19702748 · Received July 9, 2024

    Report

    Report Number
    1038671-2024-02326
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    July 23, 2021
    Report Date
    January 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862172686
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER REVIEW OF INFORMATION RECEIVED AND THE COMPLETION OF INVESTIGATION, THE FOLLOWING SECTIONS G1, G3, G6, H1, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3): THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE CAGE GLENOID COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D6. THE FOLLOWING SECTIONS WERE CORRECTED: H6. THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE CAGE GLENOID COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND IMAGES AND 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.

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM: 4889445; 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S: 4895026; 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT: 4848147; 310-01-44 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA): 4902190; A10012 - GPS IMPLANT KIT V2: 05005017040.

    Description of Event or Problem · 0

    APPROXIMATELY 4 YEAR(S) AND 17 DAY(S) POST-OPERATIVE OF A RIGHT TSA, THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING. IT WAS REPORTED AS MIGRATION OF THE CENTRAL PEG, NOW RESULTING IN COMPLETE GLENOID LOOSENING. THE PATIENT IS SCHEDULE FOR REVISION TO HEMIARTHROPLASTY, HOWEVER THE OUTCOME OF THIS EVENT IS STILL CONSIDERED CONTINUING AND THE DEVICE(S) REMAIN IMPLANTED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND DEFINITELY NOT RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498073 EQUINOXE CAGE GLENOID MEDIUM, ALPHA PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862172686

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female SEE H11.