BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS LIMB SALVAGE SYSTEM

    MDR report key: 21450369 · Received February 24, 2025

    Report

    Report Number
    3013450937-2025-00022
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    January 27, 2025
    Report Date
    February 24, 2025
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    PMA / PMN Number
    K161520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THIS COMPLAINT WAS NOT DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY L. WETZEL, AN ONKOS SALES REPRESENTATIVE, THAT A 70-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO LOOSENING OF AN ELEOS SEGMENTAL STEM THAT WAS INSERTED INTO THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404191 ELEOS LIMB SALVAGE SYSTEM ELEOS STEM KRO ONKOS SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention