BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2142325 · Received June 28, 2011

    Report

    Report Number
    3005477969-2011-00126
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 27, 2011
    Report Date
    September 14, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED DUE TO PAIN. PRIMARY SURGERY WAS PERFORMED 1.5 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR R3 CO-CR LINER NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 08KW19570 059

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R MODULAR HEAD: PART # 74222138, LOT # 09AW21272