BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3070012 · Received April 22, 2013

    Report

    Report Number
    3005477969-2013-00150
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 22, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO AN ADVERSE REACTION TO METAL DEBRIS AND A SOFT TISSUE REACTION. THE FEMORAL STEM WAS LEFT IMPLANTED. NO RADIOGRAPHIC PROBLEMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171230 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R FEMORAL STEM, (B)(4), LOT # UNKNOWN| MODULAR HEAD, (B)(4), LOT # UNKNOWN