BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 22499059 · Received July 14, 2025

    Report

    Report Number
    1038671-2025-02495
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    August 1, 2024
    Report Date
    July 14, 2025
    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) CONCOMITANT DEVICES: 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET: 6094427. 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5: 5963139. 320-15-05 - EQ REV LOCKING SCREW: 6183115. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6115462. 320-42-03 - EQUINOXE REVERSE 42MM HUMERAL LINER +2.5: 6139329. 315-35-00 - GLND KWIRE: 6103264. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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

    APPROXIMATELY 5 YEAR(S) AND 2 DAY(S) POST-OPERATIVE OF A REVISED RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED SEPTIC LOOSENING. IT WAS FURTHER STATED; FAILED BASEPLATE OF REVISION RTSA WITH GROSS PURULENCE. IN THE EARLIER REVISION, THE PATIENT EXPERIENCED INSTABILITY AND DISLOCATION THAT WAS RESOLVED WITH THE REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW. THE PATIENT UNDERWENT ANOTHER STANDARD REVERSE REVISION WITH THE REMOVAL OF THE STANDARD HUMERAL STEM, TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW, GLENOID BASE PLATE, AND COMPRESSION SCREW/LOCKING CAP. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195232 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R SEE H11.