BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS¿ LIMB SALVAGE SYSTEM

    MDR report key: 23759853 · Received December 9, 2025

    Report

    Report Number
    3013450937-2025-00397
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 8, 2025
    Manufacturer
    ONKOS SURGICAL INC.
    Product Code
    KRO
    UDI-DI
    B278RFR002E01M0
    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 DISASSOCIATION WAS NOT RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE REVISED IMPLANTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE THAT A PATIENT WITH ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025. RESURFACING FEMUR DISASSOCIATED FROM THE STEM. REPLACED STEM AND FEMUR COMPONENT. THIS REPORT CAPTURES ELEOS RESURFACING FEMUR 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
    2796728 ELEOS¿ LIMB SALVAGE SYSTEM ELEOS¿ RESURFACING FEMUR, SIZE 2, RIGHT KRO ONKOS SURGICAL INC. P220419-002 B278RFR002E01M0

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention