BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3 PRIMARY LINERS CO

    MDR report key: 4142510 · Received October 6, 2014

    Report

    Report Number
    3005477969-2014-00520
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 29, 2014
    Report Date
    January 20, 2015
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A REVISION WAS REPORTED DUE TO PAIN (ALVAL) ON THE RIGHT HIP AFTER THP METAL/METAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623678 R3 PRIMARY LINERS CO R3 40MM ID INTL COCR LINER 52MM NXT SMITH & NEPHEW ORTHOPAEDICS LTD 71335852 08LW20218062

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R MODULAR HEAD, # 74222140, LOT # 09DW23054| MODULAR SLEEVE, # 74222200, LOT # 10AW25485