BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3022520 · Received March 27, 2013

    Report

    Report Number
    3005477969-2013-00122
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    May 14, 2012
    Report Date
    March 27, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    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 PAIN. PAIN REPORTED SINCE THE DEVICES WERE IMPLANTED IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125737 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 36380 021

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R FEMORAL HEAD, PART AND LOT# UNKNOWN