BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1840800 · Received September 22, 2010

    Report

    Report Number
    3005477969-2010-00135
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    November 19, 2008
    Report Date
    September 22, 2010
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 33251 057

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R FEMORAL HEAD, PART AND LOT# UNKNOWN