Events

Retiro De Equipo (Recall) de Biolox Delta Ceramic Hip Components

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-2016-RN-01544-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-30
  • 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-2016-RN-01544-1
  • 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
    Smith & nephew is issuing this notification in relation to the ongoing use of all ceramic hip prostheses, including femoral ball heads and acetabular cup (shell) liners/ inserts that are either manufactured or distributed globally by smith & nephew. recent post-market surveillance suggests that ceramic fragments from fractured ceramic components of hip prostheses may remain in the joint during revision surgery, which may lead to premature wear in revision components if such revision components are made of non-ceramic materials. this may lead to a need for an additional revision surgery.
  • Acción
    This notification has been issued by Smith & Nephew to caution against the use of non-ceramic components when revising fractured ceramic components used in hip arthroplasty and inform surgeons of changes to the warnings in Smith & Nephew Instructions for use (IFU). Additional information is provided in the letter to surgeons and the revised IFU.

Device

Biolox Delta Ceramic Hip Components
  • Modelo / Serial
    Biolox Delta Ceramic Hip ComponentsBiolox Delta Ceramic Femoral HeadARTG Number: 218138R3 Biolox Delta Ceramic LinerARTG Number: 218185 EP-FIT Biolox Delta Ceramic InsertARTG Number: 222565
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd