BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4717538 · Received April 16, 2015

    Report

    Report Number
    3004105610-2015-00038
    Event Type
    Injury
    Date Received
    April 16, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 23, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING HISTORY OF THE COMPONENT HAS BEEN REVIEWED AND CONFIRMED THAT NO ABNORMALITIES OR DEVIATIONS WERE REPORTED. THE COMPONENT THAT WAS IMPLANTED WAS DESIGNED TO BE EXTENDED OVER TIME. THIS HAS NOW REACHED THE END OF ITS LIFE AND THE PATIENT REQUIRES A LONGER PROSTHESIS. THERE IS NO ALLEGED FAILURE OF THE DEVICE TO MEET ITS PERFORMANCE EXPECTATIONS. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR IMPLANT (K121029).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A DISTAL FEMUR JTS NON-INVASIVE GROWER PROCEDURE ON (B)(6) 2013. THE NON-INVASIVE GROWER HAS NOW REACHED MAXIMUM EXTENSION AND A REVISION PROCEDURE IS REQUIRED. THERE IS NO REPORTED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253032 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT CUSTOM DISTAL FEMORAL IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME 17644 BME 17644

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention