Events

Retiro De Equipo (Recall) de Journey BCS Knee System - Femoral Components Journey BCS CoCr Femoral Component Journey BCS Oxinium Femoral Component Journey BCS Tibial InsertAll Batch/Lot Numbers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2018-RN-00859-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-07-02
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00859-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    In january 2014, smith & nephew issued a hazard alert for the journey bcs knee system (tga ref: rc-2014-rn-00004-1) which informed surgeons of the higher than expected revision rate identified by the aoanjrr and advised of the withdrawal of the journey bcs femoral component for primary surgery from the australian market.Smith & nephew is now issuing an update following an analysis of the national joint registry of england, wales & northern ireland (njrewni) & australian orthopaedic association national joint replacement registry (aoanjrr) data on the 1st generation journey bcs knee system.The journey bcs tibial insert remains available for use but should only be used for polyethylene exchange revision of first generation journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.
  • Acción
    Surgeons should maintain their routine follow-up protocol for patients who have undergone total knee arthroplasty. Signs and symptoms to consider for potential revisions are no different from those that might be reported by any patient having undergone primary total knee arthroplasty. The need for revision should be determined on a case-by-case basis following a detailed assessment of each patient’s clinical circumstances. Smith & Nephew is not recommending pro-active revision surgeries for patients implanted with this device.

Device

Journey BCS Knee System - Femoral Components Journey BCS CoCr Femoral Component Journey BCS Oxini...
  • Modelo / Serial
    Journey BCS Knee System - Femoral ComponentsJourney BCS CoCr Femoral ComponentJourney BCS Oxinium Femoral ComponentJourney BCS Tibial InsertAll Batch/Lot NumbersMultiple Catalogue NumbersARTG Number: 278110(Smith & Nephew Pty Ltd - JOURNEY BCS Articular Insert - Prosthesis, internal, joint, knee, tibial component)
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd