BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 1984640 · Received February 11, 2011

    Report

    Report Number
    3005477969-2011-00036
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    November 23, 2010
    Report Date
    April 18, 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 ON THE PATIENT'S RIGHT HIP. THIS PATIENT HAD BILATERAL HIP REVISION SURGERIES PERFORMED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R3 ACETABULAR COCR LINER NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 08GW17705

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R MODULAR HEAD, PART#74222138, LOT# UNKOWN