BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL FEMUR IMPLANT

    MDR report key: 4373398 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00144
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED WITH THE DEVICES. THE SURGEON HAD NO OTHER ISSUES WITH THE COMPONENTS THAT WERE PROVIDED AND WAS ABLE TO COMPLETE THE PROCEDURE AS HE HAD PLANNED. REQUESTS ARE BEING MADE FOR ADD'L INFO AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFO IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR PROXIMAL FEMUR IMPLANT (K121056).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE CUSTOM DEVICE THAT WAS DESIGNED AND SUPPLIED FOR THIS PT WAS SUPPLIED WITH A MEDICAL PLATE, WHICH HAD NOT BEEN PREAPPROVED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847150 CUSTOM PROXIMAL FEMUR IMPLANT PROXIMAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME17746

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR