BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL FEMUR

    MDR report key: 7577093 · Received June 7, 2018

    Report

    Report Number
    3004105610-2018-00046
    Event Type
    Injury
    Date Received
    June 7, 2018
    Date of Event
    May 11, 2018
    Report Date
    June 7, 2018
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR TOTAL FEMUR IMPLANT (K121055) . DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT HAS A FRACTURE OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419422 TOTAL FEMUR LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE PIN 18786

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention SMBPR00 EXTRA SMALL BUMPER PAD B13002| SMBSH00 EXTRA SMALL BUSHES B13213| SMCAP01 EXTRA SMALL AXLE CAPS B11938