Events

Retiro De Equipo (Recall) de GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate

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 Surgical 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-2015-RN-00154-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-24
  • 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-2015-RN-00154-1
  • 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
    Batch number 14ct39993 of the genesis ii knee system non-porous tibial base plate (model # 71420182) were manufactured with a surface finish that does not meet smith & nephew’s product specification. this could result in poor cement adherence and the loosening of base plate. the device may fail, and revision surgery may be required.
  • Acción
    Smith & Nephew is recommending that surgeons follow standard post-operative follow-up protocols and actions for their patients and ensure that patients are informed about symptoms (particularly pain and knee instability) that might indicate the need for implant review or revision surgery, and the need to seek follow up care should these symptoms arise. For further information please see https://www.tga.gov.au/alert/genesis-ii-knee-system-non-porous-tibial-baseplate-used-knee-replacement. This action has been closed-out on 22/08/2016.

Device

GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate
  • Modelo / Serial
    GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate Model Number: 71420182 Batch Number: 14CT39993ARTG Number: 207027
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd