BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3231920 · Received July 17, 2013

    Report

    Report Number
    3005477969-2013-00297
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    February 4, 2013
    Report Date
    October 1, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALAUATION OF RADIOGRAPHS SHOWING THE POSITIONING OF THE COMPONENTS WHILST IN VIVO WAS PERFORMED IN LIEU OF RETURNED DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332297 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FEMORAL HEAD, PART# 74123144, LOT # UNKNOWN