BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3 PRIMARY LINERS CO

    MDR report key: 4222631 · Received November 4, 2014

    Report

    Report Number
    3005477969-2014-00551
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 24, 2014
    Report Date
    April 7, 2015
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PAIN, WEAKNESS OF THE LEGS AND HIPS, FLUID ACCUMULATIONS AROUND THE LEG AND HIP REPORTED.

    Description of Event or Problem · 1

    A REVISION HAS BEEN REPORTED OF A MOM TOTAL HIP. THE PATIENT WANTED THE MOM BEARING SURFACE REMOVED BECAUSE HIS CHROMIUM LEVEL WAS HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705551 R3 PRIMARY LINERS CO R3 LINER NXT SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R MODULAR SLEEVE, # (B)(4), LOT # NI| HEMI HEAD, PART # (B)(4), LOT # NI