BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID L, POST AUG, RIGHT

    MDR report key: 20665250 · Received November 12, 2024

    Report

    Report Number
    1038671-2024-04366
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    October 4, 2024
    Report Date
    May 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862201027
    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) REPORTED CONCOMITANT DEVICE(S): 300-30-12 - EQUINOXE PRESERVE STEM 12MM: 5070264. 310-00-53 - EQUINOXE, HUMERAL HEAD, EXTRA SHORT, 53MM: 4737738. 300-50-15 - 1.5MM SHORT REP PLATE: 4950568.

    Additional Manufacturer Narrative · 0

    THE PAIN REPORTED MAY BE THE RESULT OF THE GLENOID LOOSENING AS REPORTED. HOWEVER, THE GLENOID LOOSENING CANNOT BE CONFIRMED AND THE UNDERLYING REASON AND/OR ANY CONTRIBUTING FACTORS TO THE EVENT CANNOT BE CONFIRMED AS THE DEVICES REMAIN IMPLANTED AND NO RADIOGRAPHS WERE PROVIDED. H6: CORRECTED COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    APPROXIMATELY 7 YEAR(S) AND 1 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. PATIENT BEGAN HAVING PAIN AND NUMBNESS WITHOUT INJURY. THE PATIENT WAS ADMINISTERED MEDICATION, AND THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135069 EQUINOXE CAGE GLENOID L, POST AUG, RIGHT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862201027

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention SEE H11