BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS¿ LIMB SALVAGE SYSTEM

    MDR report key: 25318158 · Received May 28, 2026

    Report

    Report Number
    3013450937-2026-00222
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 28, 2026
    Manufacturer
    ONKOS SURGICAL INC.
    Product Code
    KRO
    UDI-DI
    B278HC1112003M0
    PMA / PMN Number
    K161520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THIS COMPLAINT WAS NOT DETERMINED. BASED ON THE REVIEW OF KNOWN DEVICE HISTORY RECORDS, THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE LOOSENING WAS NOT RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE REVISED IMPLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT AN 81-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION ON (B)(6) 2026 DUE TO LOOSENING OF THE FEMORAL STEM. THIS REPORT CAPTURES ELEOS SEGMENTAL STEM. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358774 ELEOS¿ LIMB SALVAGE SYSTEM SEGMENTAL COLLAR STEM, CEMENTED, 11MM X 120MM KRO ONKOS SURGICAL INC. P230194-101 B278HC1112003M0

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention