BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 24674918 · Received March 24, 2026

    Report

    Report Number
    1038671-2026-00326
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 24, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 300-30-11 - EQUINOXE PRESERVE STEM 11MM: 6860297 322-38-00 - 145-DEG PE 38MM HUM LINER +0: B772042 322-10-05 - HUMERAL ADAPTER TRAY, +5: B592054 320-06-38 - GLENOSPHERE 38MM: B517773 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG: B545700 320-15-05 - EQ REV LOCKING SCREW: B795014 SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A CLINICAL STUDY, THAT A 68 YO FEMALE PATIENT HAD A GREATER TUBEROSITY FRACTURE DURING DISLOCATION INTRAOPERATIVELY WHILE PERFORMING A TSA PROCEDURE. ACTION TAKEN WAS THAT THE GLENOID WAS REMOVED AND THE TSA WAS CONVERTED TO A RTSA INTRAOPERATIVELY. THE REPORTED INFORMATION INDICATED THE EVENT WAS UNLIKELY TO BE RELATED TO THE DEVICES BUT DEFINITELY RELATED TO THE PROCEDURE. THE OUTCOME INDICATES CONTINUING. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736693 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H SEE H11