BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS LIMB SALVAGE SYSTEM

    MDR report key: 20521993 · Received October 24, 2024

    Report

    Report Number
    3013450937-2024-00346
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    October 10, 2024
    Report Date
    October 24, 2024
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    UDI-DI
    B27825000007E0
    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 INFECTION WAS NOT RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE REVISED ELEOS IMPLANTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY H. LEWIS, AN ONKOS SALES REPRESENTATIVE, THAT A MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO AN ALLEGED PERI-OPERATIVE INFECTION. THE ELEOS CANAL FILLING SEGMENTAL STEM REPORTEDLY LOOSENED DURING THE REMOVAL OF THE ATTACHED MIDSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561364 ELEOS LIMB SALVAGE SYSTEM DISTAL FEMUR KRO ONKOS SURGICAL 1999577 B27825000007E0

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention CANAL FILLING SEGMENTAL STEM| DISTAL FEMUR| DISTAL FEMUR AXIAL PIN| MALE-FEMALE MIDSECTION| TIBIAL POLY SPACER| TIBIAL ROTATIONAL HINGE