BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3842966 · Received June 2, 2014

    Report

    Report Number
    3005477969-2014-00350
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 23, 2014
    Report Date
    August 19, 2014
    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 A REVISION SURGERY WAS PERFORMED DUE TO FRACTURE, HOWEVER, THE PATIENT HAD A HISTORY OF GROIN PAIN ONSET BEFORE FRACTURE. REVISION SURGEON REPORTED THE DEVICES HAD BEEN IMPLANTED FOR APPROXIMATELY 10 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322365 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 50623 147

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R FEMORAL HEAD, PART# 74121146, LOT# 50595