BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 1962056 · Received January 17, 2011

    Report

    Report Number
    3005477969-2011-00015
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 10, 2010
    Report Date
    April 14, 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 REVISION SURGERY WAS PERFORMED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R3 ACETABULAR LINER NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 07MW15114

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R FEMORAL HEAD, PART#74222140, LOT# 07EW11858| MODULAR SLEEVE, PART#74222100 , LOT#07LW14551