BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 3172713 · Received June 17, 2013

    Report

    Report Number
    3005477969-2013-00251
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 1, 2014
    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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS SCHEDULED TO BE PERFORMED. DETERIORATING MOBILITY AND PAIN WHEN WALKING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273677 R3 COCR ACETABULAR LINER NXT SMITH & NEPHEW ORTHOPAEDICS LTD 07KW14510

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SPHERICAL SCREW, # 71332515, LOT # 08AT16510| FEMORAL STEM, # 71357004, LOT # 07HM19429A| MODULAR HEAD, # 74222144, LOT # 08CW16170| SPHERICAL SCREW, # 71332530, LOT # 08FT21408| MODULAR SLEEVE, # 74222300, LOT # 08AW15194| ACETABULAR SHELL, # 71335556, LOT# 07LM12094A