BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS LIMB SALVAGE SYSTEM

    MDR report key: 21464222 · Received February 25, 2025

    Report

    Report Number
    3013450937-2025-00024
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    January 31, 2025
    Report Date
    February 25, 2025
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    UDI-DI
    B27826000026E0
    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 REPORTED DISLOCATION WERE NOT RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE INVESTIGATED IMPLANTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY K. HLAVATY, AN ONKOS SALES REPRESENTATIVE, THAT A 72-YEAR-OLD MALE PATIENT WITH AN ELEOS TOTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON 31 JANUARY 2025 DUE TO THE DISLOCATION OF THE IMPLANTED ELEOS FEMORAL HEAD FROM A NON-ONKOS BIPOLAR ACETABULAR LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249584 ELEOS LIMB SALVAGE SYSTEM FEMORAL HEAD KRO ONKOS SURGICAL 1711958 B27826000026E0

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention FEMORAL HEAD| PROXIMAL FEMUR