BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1990441 · Received February 15, 2011

    Report

    Report Number
    3005477969-2011-00044
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 14, 2011
    Report Date
    May 24, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO AVASCULAR NECROSIS-AVN (DEAD HEAD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR FEMORAL HEAD NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 08CW16386 026

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR ACETABULAR CUP, PART # 7414120152,LOT # 07MW15032