BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 3010742 · Received March 19, 2013

    Report

    Report Number
    3005477969-2013-00094
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 13, 2012
    Report Date
    March 19, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMBINATION OF PARTS USED IN THIS CASE CONSTITUTE AN OFF LABEL APPLICATION IN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND DIFFICULTY WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114446 R3 COCR ACETABULAR LINER NXT SMITH & NEPHEW ORTHOPAEDICS LTD 08MW20547

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SPHERICAL SCREW, # 71332525, LOT# 08F21502| HEMI HEAD, # 74122538, LOT# 07MW15125| SPHERICAL SCREW, # 71332525, LOT# 08KT25343| ACETABULAR SHELL, # 71335550, LOT# 09CM16444