BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2123046 · Received June 14, 2011

    Report

    Report Number
    3005477969-2011-00116
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE FAILURE HAS OCCURRED, HOWEVER, NO FURTHER INFORMATION HAS BEEN SUPPLIED TO THE MANUFACTURER AS OF (B)(6) 2011.

    Devices

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

    Patients

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