BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2940486 · Received February 4, 2013

    Report

    Report Number
    3005477969-2013-00037
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 18, 2012
    Report Date
    April 8, 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 A REACTION TO WEAR DEBRIS DUE TO RECURRENT SUBLUXATION OF THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46197 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 10HW29560 023

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R FEMORAL HEAD, PART# 74121150, LOT# 10HW02894 030