BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3013211 · Received March 20, 2013

    Report

    Report Number
    3005477969-2013-00098
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    July 10, 2012
    Report Date
    March 20, 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. THE DEVICES WERE IMPLANTED IN 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116090 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 60167 144

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R FEMORAL HEAD, PART# 121146, LOT# 8141 012