BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS LIMB SALVAGE SYSTEM

    MDR report key: 20339735 · Received September 30, 2024

    Report

    Report Number
    3013450937-2024-00307
    Event Type
    Injury
    Date Received
    September 30, 2024
    Report Date
    September 30, 2024
    Manufacturer
    ONKOS SURGICAL INC
    Product Code
    KRO
    UDI-DI
    B278THSMWRS01M0
    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

    IT WAS REPORTED THAT THE PATIENT HAD AN ALLEGED INFECTION. THE PATIENT WAS IMPLANTED WITH AN ONKOS DISTAL FEMORAL REPLACEMENT ON (B)(6) 2024. THE PATIENT UNDERWENT A PROCEDURE TO REMOVE ALL HARDWARE AND ELECTED TO UNDERGO AN AMPUTATION ON (B)(6) 2024. ALL MANUFACTURING RECORDS OF IMPLANTED DEVICES WERE REVIEWED AND NO MANUFACTURING ABNORMALITIES WERE OBSERVED. AS DETAILED IN THE ELEOS LIMB SALVAGE SYSTEM IFU AND SURGICAL TECHNIQUE DOCUMENTATION, ELEMENTS SUCH AS PATIENT CONTRAINDICATIONS, PATIENT SELECTION FACTORS, SURGICAL PROCEDURES/TECHNIQUES AND OTHER PRECAUTIONS/CONDITIONS MAY CONTRIBUTE TO ADVERSE EFFECTS. THE ROOT CAUSE OF THIS EVENT 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 LIKELY RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE ONKOS IMPLANTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH AN ONKOS DISTAL FEMORAL REPLACEMENT HAD AN ALLEGED INFECTION. THE PATIENT'S INDEX PROCEDURE OCCURED ON (B)(6) 2024. THE PATIENT UNDERWENT A PROCEDURE TO REMOVE ALL HARDWARE AND ELECTED TO UNDERGO AN AMPUTATION ON (B)(6) 2024. THIS EVENT WILL BE REPORTABLE TO THE FDA DUE TO THE REVISION PROCEDURE. THIS REPORT CAPTURES THE EXPLANTED ELEOS TIBIAL HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41637 ELEOS LIMB SALVAGE SYSTEM TIBIAL HINGE WITH ROTATIONAL STOP KRO ONKOS SURGICAL INC 1993054 B278THSMWRS01M0

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention