BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR IMPLANT

    MDR report key: 4373071 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00172
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    May 1, 2014
    Report Date
    April 16, 2014
    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 MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. RADIOGRAPHS HAVE BEEN REVIEWED AND THE FRACTURE CAN BE OBSERVED. IT IS NOT KNOWN AT THIS TIME THE ROOT CAUSE FOR THE REPORTED FRACTURE. 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 SMILES TOTAL KNEE REPLACEMENT IMPLANT (K120992).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A DISTAL FEMUR REPLACEMENT PROCEDURE ON (B)(6) 2013 AND SUBSEQUENTLY WAS REVISED IN (B)(6) 2014 DUE TO A FRACTURE OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850829 CUSTOM DISTAL FEMUR IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME18146

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other