BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4364952 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00114
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    October 24, 2012
    Report Date
    October 2, 2012
    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

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS NOT BEEN RETURNED, THEREFORE A VISUAL INSPECTION HAS NOT BEEN POSSIBLE. REVIEW OF X-RAYS PROVIDED CONFIRM THAT THE PROSTHESIS HAS BECOME DISASSEMBLED. THE INVESTIGATION CONCLUDED THAT THE PROSTHESIS HAD BEEN OVER EXTENDED, WHICH CAUSED IT TO BE DISASSEMBLED. THE PATIENT HAS NOW BEEN REVISED TO A STANDARD DISTAL FEMUR AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. 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 AN EXTENDIBLE DISTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 2009 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO THE EXTENDIBLE PROSTHESIS BECOMING DISASSEMBLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838298 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME14496

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention