BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID M, POST AUG, RIGHT

    MDR report key: 17396591 · Received July 26, 2023

    Report

    Report Number
    1038671-2023-01776
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862201010
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: 6117669, 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. 6157388, 300-30-08 - EQUINOXE PRESERVE STEM 8MM. 6230887, 300-50-45 - 4.5MM SHORT REP PLATE. 5207950, 310-01-50 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA). 6350842, 315-35-00 - GLND KWIRE. 5966417, 531-78-20 - SHOULDR GPS HEX PINS KIT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE GLENOID FAILURE REPORTED MAY BE THE RESULT OF THE GLENOID LOOSENING AS REPORTED. HOWEVER, THE FAILURE CANNOT BE CONFIRMED AS NO RELEVANT CLINICAL INFORMATION, IMAGES, OR RADIOGRAPHS WERE PROVIDED. POTENTIAL CONTRIBUTIONS OF MANUFACTURING, PATIENT, OR USER-RELATED ISSUES TO THE EVENT CANNOT BE DETERMINED 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

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE 65 YO MALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. THE DATE OF EVENT ONSET IS (B)(6) 2023. THE PATIENT WAS REVISED ON (B)(6) 2023. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813337 EQUINOXE CAGE GLENOID M, POST AUG, RIGHT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. UNK UNK 10885862201010

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| O SEE H10