BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS LIMB SALVAGE SYSTEM

    MDR report key: 22890797 · Received August 25, 2025

    Report

    Report Number
    3013450937-2025-00168
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 25, 2025
    Manufacturer
    ONKOS SURGICAL INC
    Product Code
    KRO
    UDI-DI
    B278HC1512003M0
    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 D. HARDARDT, AND ONKOS SALES REPRESENTATIVE THAT A 33-YEAR-OLD MALE PATIENT WITH AN ELEOS PROXIMAL TIBIAL REPLACEMENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY AND NEEDED A CHANGE IN CONSTRUCT. CONVERTED THEIR RESURFACING FEMUR WITH PTR TO A DTR/PTR. REVISED ELEOS STEM FOR LOOSENING IN TIBIA. THIS REPORT CAPTURES THE ELEOS CANAL FILLING 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
    2723275 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL COLLAR STEM, CEMENTED, 15MM X 100MM KRO ONKOS SURGICAL INC P230013-014 B278HC1512003M0

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention