BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRESERVE STEM 6MM

    MDR report key: 21914518 · Received April 25, 2025

    Report

    Report Number
    1038671-2025-01899
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    April 4, 2025
    Report Date
    April 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    UDI-DI
    10885862515742
    PMA / PMN Number
    K162726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. D10: (B)(6), 320-08-42 - GLENOSPHERE EXP 42MM +4MM OFFSET. (B)(6), 320-15-01 - EQ REV GLENOID PLATE. (B)(6), 320-15-05 - EQ REV LOCKING SCREW. (B)(6), 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. (B)(6), 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. (B)(6), 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM. (B)(6), 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1 YEAR AND 3 MONTHS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO THE STEM BEING LOOSE AND THE POLY BEING DISSOCIATED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346344 EQUINOXE PRESERVE STEM 6MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC. 10885862515742

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization SEE H11