BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3801626 · Received May 9, 2014

    Report

    Report Number
    3005477969-2014-00311
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    February 11, 2014
    Report Date
    November 12, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280227 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 09CW22386

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R FEMORAL HEAD, PART# 74123148, LOT# 09AW21584