BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PROXIMAL FEMUR

    MDR report key: 6216865 · Received December 31, 2016

    Report

    Report Number
    3004105610-2016-00128
    Event Type
    Injury
    Date Received
    December 31, 2016
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PATHOLOGY REPORTS, PRODUCT RETURN, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. INFECTION IS A PROCEDURE-RELATED ASPECT OF ARTHROPLASTY WITH SOMETIMES ADDITIONAL PATIENT-RELATED RISK FACTORS FOR INFECTION AND IS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. STANMORE WILL CONTINUE TO MONITOR FOR TRENDS. THIS COMPLAINT WAS IDENTIFIED AS REQUIRING MDR REPORTING DURING THE COMPLAINT INVESTIGATION REMEDIATION PROJECT ONGOING AT STANMORE IMPLANTS WORLDWIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANT WAS INFECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866812 CUSTOM PROXIMAL FEMUR LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 15390 PIN 15390

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention