BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2192408 · Received August 5, 2011

    Report

    Report Number
    3005477969-2011-00168
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    March 3, 2006
    Report Date
    October 27, 2011
    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 FEMORAL HEAD REVISION WAS PERFORMED. REPLACED WITH MODULAR FEMORAL HEAD AND FEMORAL STEM, ACETABULAR CUP REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR RESURFACING FEMORAL HEAD NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 10061

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R ACETABULAR CUP: PART# 120152, LOT# 7563