BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 4212418 · Received October 30, 2014

    Report

    Report Number
    3005477969-2014-00550
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 30, 2014
    Manufacturer
    SMITH & NEPHEW
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 AROUND ACETABULUM AND GREATER TROCHANTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695042 BHR ACETABULAR CUP NXT SMITH & NEPHEW 92546 005

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R MODULAR SLEEVE, PART AND LOT # UNKNOWN