BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3172165 · Received June 17, 2013

    Report

    Report Number
    3005477969-2013-00247
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    June 7, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ABOUT 3 WEEKS AGO (APPROXIMATELY THE WEEK OF (B)(6), 2013). THE REASON FOR THE REVISION HAS NOT BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273356 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD.

    Patients

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