BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL IMPACTOR

    MDR report key: 4152602 · Received October 2, 2014

    Report

    Report Number
    MW5038497
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    June 3, 2014
    Report Date
    October 2, 2014
    Manufacturer
    DEPUY SYNTHES
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN REVIEWING A SERIES OF JOINT INFECTIONS THAT APPEARED TO BE CLUSTERED TOGETHER, WE DETERMINED THAT ONE LINK FOR ALL OF THESE SURGICAL PROCEDURES WAS THIS DEVICE. THE MANUFACTURER WAS CONTACTED, AND WE DETERMINED THAT WE WERE CLEANING AND PROCESSING THIS DEVICE ACCORDING TO THE MANUFACTURER'S RECOMMENDED PROCEDURE. OUR STERILE PROCESSING STAFF NOTICED THE DEVICE HAD A SCREWS THAT COULD BE REMOVED, HOWEVER, WE WERE TOLD THAT THEY DID NOT NEED TO BE REMOVED. WE REMOVED THE SCREWS AND FOUND BIO-BURDEN IN THE DEVICE. THIS WAS AGAIN SHARED WITH THE MANUFACTURER WHO SAID THERE WAS NO WAY FOR THIS TO GET OUT OF THE DEVICE. WE HAVE STOPPED USING THIS DEVICE AT OUR FACILITY. WE FEEL THIS DEVICE MAY HAVE BEEN A CAUSATIVE FACTOR IN THE JOINT INFECTIONS, HOWEVER, ARE UNABLE TO MAKE A DIRECT LINK. SAME REPORTER AS MW5038492, MW5038493, MW5038494, MW5038495, MW5038496.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613987 FEMORAL IMPACTOR FEMORAL IMPACTOR LXH DEPUY SYNTHES
    613988 TIBIAL TRAY TIBIAL TRAY JWH DEPUY SYNTHES
    614116 DEPUY SYNTHES UNIVERSAL HANDLE UNIVERSAL HANDLE LXH DEPUY SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention