BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL GLENOID PLATE

    MDR report key: 23187509 · Received September 30, 2025

    Report

    Report Number
    1038671-2025-03023
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    September 10, 2025
    Report Date
    September 30, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: B409485 300-30-10 - EQUINOXE PRESERVE STEM 10MM. B449146 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. B057109 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. B209238 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. B240577 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. B292385 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. B033249 320-32-40 - EXPANDED GLENOSPHERE, 40MM, FOR SMALL REVERSE. B432258 322-10-00 - HUMERAL ADAPTER TRAY, +0. B221017 322-40-00 - 145-DEG PE 40MM HUM LINER +0. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT WHO HAD A LEFT SHOULDER IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 MONTHS POST THE INITIAL PROCEDURE. THE GLENOSPHERE LOCKING SCREW BACKED OUT BUT WAS STILL ATTACHED TO BASEPLATE. THE SURGEON ASKED TO SEND EQUIPMENT IN A TEST, (POST-OP X-RAYS FOR FOLLOW UP). THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED FOR REVIEW. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155412 SMALL GLENOID PLATE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11.