BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4616404 · Received March 13, 2015

    Report

    Report Number
    3004105610-2015-00028
    Event Type
    Malfunction
    Date Received
    March 13, 2015
    Date of Event
    February 13, 2015
    Report Date
    February 13, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. BASED ON THE LENGTH OF IMPLANTATION OF 29 YEARS THE PLASTIC COMPONENTS NEED REPLACING DUE TO NORMAL WEAR AND TEAR. THERE IS NO ALLEGED FAILURE OF THE DEVICE TO PERFORM. 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 SURGEON THAT THE PATIENT UNDERWENT A PRIMARY DISTAL FEMUR PROCEDURE FOR THE TREATMENT OF OSTEOSARCOMA ON (B)(6) 1986. SUBSEQUENTLY THE PATIENT NOW REQUIRES A PROCEDURE TO REPLACE THE PLASTIC BEARING COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174686 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT CUSTOM DISTAL FEMORAL IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME 819 BME 819

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention