BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS¿ LIMB SALVAGE SYSTEM

    MDR report key: 23515117 · Received November 10, 2025

    Report

    Report Number
    3013450937-2025-00326
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 15, 2025
    Report Date
    July 30, 2025
    Manufacturer
    ONKOS SURGICAL INC.
    Product Code
    KRO
    UDI-DI
    B278FS1912003M0
    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 ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 SHOWING SIGNS OF LOOSENING ON X-RAY AND ALLEGED INFECTION. 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
    2524774 ELEOS¿ LIMB SALVAGE SYSTEM ELEOS SEGMENTAL STEM, CANAL FILLING, STRAIGHT, SPLINED, FULL PLASMA, 36MM COLLAR KRO ONKOS SURGICAL INC. P230124-002 B278FS1912003M0

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention