BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2182741 · Received July 28, 2011

    Report

    Report Number
    3005477969-2011-00162
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    February 7, 2011
    Report Date
    July 28, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO FEMORAL NECK FRACTURE 6 WEEKS POST-OPERATIVELY. ONLY THE FEMORAL HEAD COMPONENT WAS REVISED, THE ACETABULAR CUP INVOLVED REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ACETABULAR CUP, PART# 74120156, LOT # UNKNOWN