BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM DISTAL FEMUR IMPLANT

    MDR report key: 6066980 · Received October 31, 2016

    Report

    Report Number
    3004105610-2016-00110
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K140898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT SUCCESSFUL REVISION OF THE DISTAL FEMUR. A DEFINITIVE ROOT CAUSE OF THE LOOSENING HAS NOT BEEN IDENTIFIED. THE OBSERVED LOOSENING COULD BE AS A RESULT OF PATIENT FACTORS SUCH AS TRAUMA, OBESITY, ACTIVITY LEVELS, DISEASE PROGRESSION AND/OR SURGICAL FACTORS, AS IN THIS REPORTED EVENT, OR SURGICAL PREFERENCES AND NOT NECESSARILY RELATED TO THE DEVICE ITSELF. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED. THIS COMPLAINT FILE WAS REVIEWED AS PART OF STANMORE IMPLANTS WORLDWIDE COMPLAINT FILE REMEDIATION PROGRAMME AND IT HAS BEEN DETERMINED THAT AN MDR SHOULD BE FILED. THIS COMPLAINT WAS RECEIVED BY (B)(4) IN (B)(6) 2013.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT'S DISTAL FEMUR IMPLANT, HAS LOOSENING OF THE INTRAMEDULLARY STEM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719381 CUSTOM DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 15959 PIN 15959

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization