BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS¿ LIMB SALVAGE SYSTEM

    MDR report key: 24247243 · Received February 3, 2026

    Report

    Report Number
    3013450937-2026-00067
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 3, 2026
    Manufacturer
    ONKOS SURGICAL INC.
    Product Code
    KRO
    UDI-DI
    B27825001050E0
    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.

    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 P. MEDINA, AN ONKOS SALES REPRESENTATIVE, THAT A 21-YEAR-OLD MALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO LOOSENING OF CEMENTED STEM. IT WAS REPORTED THAT THE STEM WAS REPLACED FOR BETTER FIXATION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY P. MEDINA, AN ONKOS SALES REPRESENTATIVE, THAT A 21-YEAR-OLD MALE PATIENT WITH AN ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO LOOSENING OF CEMENTED STEM. IT WAS REPORTED THAT THE STEM WAS REPLACED FOR BETTER FIXATION. THIS REPORT CAPTURES ELEOS MALE-FEMALE MIDSECTION. 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
    312585 ELEOS¿ LIMB SALVAGE SYSTEM ELEOS¿ MALE-FEMALE MIDSECTION 50MM KRO ONKOS SURGICAL INC. 2029637 B27825001050E0

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Male Required Intervention