BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS LIMB SALVAGE SYSTEM

    MDR report key: 22797836 · Received August 13, 2025

    Report

    Report Number
    3013450937-2025-00164
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 13, 2025
    Manufacturer
    ONKOS SURGICAL INC
    Product Code
    KRO
    PMA / PMN Number
    K161520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 LOOSENING WAS NOT RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE REVISED IMPLANTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY J. ELLINTHORPE, AND ONKOS SALES REPRESENTATIVE, THAT A 22-YEAR-OLD FEMALE PATIENT WITH AN ELEOS PROXIMAL TIBIA REPLACEMENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025 DUE TO LOOSENING ON THE FEMORAL SIDE. THIS REPORT CAPTURES THE ELEOS STEM EXTENSION. 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
    624738 ELEOS LIMB SALVAGE SYSTEM ELEOS¿ STEM EXTENSION15X100MM STRAIGHT, SPLINED, SLOTTED 15X100MM  KRO ONKOS SURGICAL INC  1895747 

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention