BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 23866310 · Received December 22, 2025

    Report

    Report Number
    1038671-2025-03595
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 300-01-13 EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM 7183154. 320-01-42 EQUINOXE REVERSE 42MM GLENOSPHERE 7210612. 320-10-00 EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 7259345. 320-15-03 RS GLENOID PLATE POST AUG, 8 DEG, LEFT 6600541. 320-15-05 EQ REV LOCKING SCREW 7323289. 320-20-00 EQ REVERSE TORQUE DEFINING SCREW KIT 7277867. 320-20-26 EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S354751. 320-20-26 EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S357946. 320-20-30 EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S342787. 320-42-00 EQUINOXE REVERSE 42MM HUMERAL LINER +0 S281906. 531-78-20 SHOULDR GPS HEX PINS KIT 7264842. A10012 - GPS IMPLANT KIT V2 08000321121. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTS ARE IN-SITU, THEY WERE NOT REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329478 EQUINOXE REVERSE SHOULDER COMPONENTS SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization SEE H11.