BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS¿ LIMB SALVAGE SYSTEM

    MDR report key: 25229968 · Received May 20, 2026

    Report

    Report Number
    3013450937-2026-00208
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 20, 2026
    Manufacturer
    ONKOS SURGICAL INC.
    Product Code
    KRO
    UDI-DI
    B278THSMWRS01M0
    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 ALLEGED INFECTION 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 AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2026 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES ELEOS TIBIAL HINGE. 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
    301245 ELEOS¿ LIMB SALVAGE SYSTEM ELEOS¿ TIBIAL HINGE W/ ROTATIONAL STOP ONE SIZE KRO ONKOS SURGICAL INC. 2073092 B278THSMWRS01M0

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention