BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRESERVE STEM 6MM

    MDR report key: 17411030 · Received July 27, 2023

    Report

    Report Number
    1038671-2023-01803
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    June 26, 2023
    Report Date
    October 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862515742
    PMA / PMN Number
    K162726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: HUMERAL STEM OR STEMLESS 3003006. REVERSE HUMERAL LINER 3203800. REVERSE HUMERAL TRAY 3201000. REVERSE GLENOSPHERE BASEPLATE 3201508.

    Description of Event or Problem · 0

    IT WAS REPORTED POST-OP VIA CLINICAL STUDY THAT THE 73 YO FEMALE PATIENT EXPERIENCED A PROXIMAL THIRD OF HUMERUS PERIPROSTHETIC FRACTURE (HUMERAL FX TUBEROSITY). THE DATE OF EVENT ONSET IS (B)(6) 2023. THE PATIENT WAS REVISED ON (B)(6) 2023. THE OUTCOME WAS LAST KNOWN AS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920712 EQUINOXE PRESERVE STEM 6MM PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862515742

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other| R