BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4365000 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00110
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    August 29, 2012
    Report Date
    August 22, 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. AS THE DEVICE HAS BEEN IMPLANTED FOR 19 YEARS, IT IS LIKELY THAT THE WEAR OF THE BUSHES IS RELATED TO NORMAL WEAR AND TEAR OF THE DEVICE, HOWEVER, THIS CANNOT BE CONFIRMED WITH THE CURRENT AVAILABLE INFORMATION. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. 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 DISTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 1993 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 AS A REBUSHING WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839330 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME2783

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention