BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4630202 · Received March 20, 2015

    Report

    Report Number
    3004105610-2015-00031
    Event Type
    Injury
    Date Received
    March 20, 2015
    Date of Event
    March 18, 2015
    Report Date
    February 25, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    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. THE COMPONENT WAS IMPLANTED IN 1986, SO THE FAILURE IS MOST LIKELY DUE TO NORMAL WEAR AND TEAR OF THE DEVICE. NO DEVICE FAILURE HAS BEEN ALLEGED BY THE SURGEON. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR IMPLANT (K121029).

    Description of Event or Problem · 1

    DURING A REBUSHING PROCEDURE THAT WAS CARRIED OUT THE SURGEON IDENTIFIED THAT THE PROSTHESIS WAS WORN AND REQUIRED A REVISING. THE ORIGINAL PROSTHESIS WAS IMPLANTED ON (B)(6) 1986.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192082 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