BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3961496 · Received July 28, 2014

    Report

    Report Number
    3005477969-2014-00429
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 22, 2014
    Report Date
    January 7, 2015
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO UNEXPLAINED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437538 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 10MW31149 005

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R MODULAR HEAD, PART #74432046 AND LOT #UNKNOWN| FEMORAL STEM, PART #74431311 AND LOT #UNKNOWN