BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PROXIMAL FEMORAL REPLACEMENT IMPLANT

    MDR report key: 6140625 · Received December 2, 2016

    Report

    Report Number
    3004105610-2016-00121
    Event Type
    Injury
    Date Received
    December 2, 2016
    Report Date
    June 26, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    JDI
    PMA / PMN Number
    K121056
    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 PROXIMAL FEMUR. A DEFINITIVE ROOT CAUSE OF THE ASEPTIC LOOSENING HAS NOT BEEN IDENTIFIED, HOWEVER ASEPTIC LOOSENING CAN BE A WELL-KNOWN MODE OF FAILURE FOR ORTHOPAEDIC IMPLANTS, WHICH MAY OCCUR AS AN EARLY OR A LATE COMPLICATION. THERE WERE NO REPORTED COMPLICATIONS RESULTING FROM THE REVISION SURGERY. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SIGNS OF THE IMPLANT STEM LOOSENING AND IT CONSEQUENTLY SUBSIDED. THE DEVICE HAD BEEN IMPLANTED IN 2004. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793042 CUSTOM PROXIMAL FEMORAL REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM JDI STANMORE IMPLANTS WORLDWIDE LTD PIN 10534 PIN 10534

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention