BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2913751 · Received January 14, 2013

    Report

    Report Number
    3005477969-2013-00018
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    June 28, 2012
    Report Date
    July 1, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USE OF A COMPETITOR FEMORAL STEM IN CONJUNCTION WITH THESE DEVICES CONSTITUTES AN OFF-LABEL APPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

    Description of Event or Problem · 1

    THE ACETABULAR CUP INVOLVED IN THIS EVENT WAS IMPLANTED ON (B)(6) 2004. THE FEMORAL HEAD, MODULAR SLEEVE AND COMPETITOR (BIOMET) FEMORAL STEM INVOLVED WERE IMPLANTED ON (B)(6) 2010. THE ACETABULAR CUP, FEMORAL HEAD, AND MODULAR SLEEVE WERE ALL REVISED ON (B)(6) 2012. IT IS UNKNOWN IF THE FEMORAL STEM REMAINS IMPLANTED OR WAS ALSO REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19701 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 31212

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R BIOMET FEMORAL STEM, #650-0322, LOT# 1266081,| MODULAR SLEEVE, PART# 74222100, LOT# 08KW19681| MODULAR HEAD, PART #74222154, LOT# 9990