BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS¿ LIMB SALVAGE SYSTEM

    MDR report key: 23744565 · Received December 8, 2025

    Report

    Report Number
    3013450937-2025-00394
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 8, 2025
    Manufacturer
    ONKOS SURGICAL INC.
    Product Code
    KRO
    UDI-DI
    B278CS1312003M0
    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 OF THE SEGMENTAL STEM WAS NOT RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE REVISED IMPLANTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY M. POST, AN ONKOS DISTRIBUTOR, THAT A 15-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL TIBIAL REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO ASEPTIC LOOSENING OF A CEMENTED SEGMENTAL 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
    2437372 ELEOS¿ LIMB SALVAGE SYSTEM ELEOS SEGMENTAL STEM, CEMENTED, STRAIGHT, FLUTED, 28MM COLLAR, 13MM X 120MM KRO ONKOS SURGICAL INC. P241108-004 B278CS1312003M0

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Required Intervention