BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3181345 · Received June 21, 2013

    Report

    Report Number
    3005477969-2013-00257
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED APPROXIMATELY 1 WEEK AFTER DEVICE IMPLANTATION DUE TO FEMORAL COLLAPSE. THE PATIENT'S FEMUR WAS REPORTEDLY PINNED AND THE HIP REPLACEMENT REVISED TO A PROSTHESIS COMPRISING COMPONENTS MANUFACTURED BY THE SMITH & NEPHEW AND JRI ORTHOPAEDICS LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282047 BHR RESURFACING FEMORAL HEAD NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 21870

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ACETABULAR CUP, PART# (B)(4), LOT# 21578