BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 2895953 · Received January 4, 2013

    Report

    Report Number
    3005477969-2013-00008
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Removal / Correction Number
    MW1209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMBINATION OF DEVICES USED IN THIS CASE CONSTITUTES AN OFF LABEL APPLICATION IN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY IS SCHEDULED FOR (B)(6) 2013 DUE TO AN ADVERSE REACTION TO METAL AND A SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5117 R3 COCR ACETABULAR LINER NXT SMITH & NEPHEW ORTHOPAEDICS LTD 09AW20958

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R MODULAR SLEEVE, PART# (B)(4), LOT# 08GW17830| HEMI HEAD, PART# (B)(4), LOT# 08JW18940