BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3131948 · Received May 29, 2013

    Report

    Report Number
    3005477969-2013-00219
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 7, 2013
    Report Date
    February 28, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234412 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 53355 038

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FEMORAL HEAD, PART # 74121146, LOT # 50892 154