BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 24173085 · Received January 24, 2026

    Report

    Report Number
    1038671-2026-00075
    Event Type
    Injury
    Date Received
    January 24, 2026
    Date of Event
    January 13, 2026
    Report Date
    March 3, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION PERTAINING TO THIS EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. AS A RESULT, THIS COMPLAINT EVENT IS NO LONGER CONSIDERED REPORTABLE BY EXACTECH AND THIS REPORT MAY BE DISREGARDED.

    Additional Manufacturer Narrative · 0

    D10: 300-30-08 - EQ PRESERVE STEM 8MM: A887061. 320-01-42 - EQ REV 42MM GLENOSPHERE: B107069. 320-10-00 - EQ REVTRAY ADAPTER PLATE TRAY +0: B093345. 320-15-04 - RS GLENOID PLATE POST AUG, 8 DEG, RIGHT: B052519. 320-15-05 - EQ REV LOCKING SCREW: B229955. 320-20-00 - EQ REVTORQUE DEFINING SCREW KIT: B098607. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED AN 85 YO MALE PATIENT, WHO HAD A RIGHT TSA UNDERWENT A REVISION PROCEDURE. THE PATIENT HAD A TRAUMATIC DISLOCATION. THE GLENOSPHERE, LINER, AND ADAPTOR TRAY WERE REPLACED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE UNABLE TO BE OBTAINED. THE EXPLANTED PRODUCTS WERE DISCARDED BY THE CUSTOMER. NO PHOTOS WERE OBTAINED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545691 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention| H SEE H11.