BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4784825 · Received May 15, 2015

    Report

    Report Number
    3004105610-2015-00046
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 16, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K140898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE POST OPERATIVE X-RAYS CONFIRMS THE REPORTED FEMUR FRACTURE. THE CIRCLAGE WIRES THAT WERE USED TO REPAIR THE FRACTURE CAN ALSO BE IDENTIFIED. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRM THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION WITH NO ABNORMALITIES OR DEVIATIONS IDENTIFIED. FURTHER INFORMATION HAS BEEN REQUESTED AND A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR (K121029).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT DURING THE IMPACTION OF THE FEMORAL COMPONENT, ABOUT 10MM BEFORE IT WAS FULLY INSERTED, THE FEMUR FRACTURED WITH A LONGITUDINAL FRACTURE. THE FRACTURE WAS REPAIRED USING CIRCLAGE WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318618 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME 19348 BME 19348

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male Required Intervention