Events

Retiro De Equipo (Recall) de Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short Neck

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Surgical Specialties 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-2017-RN-00233-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-17
  • 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-2017-RN-00233-1
  • 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
    An investigation was completed following a complaint by a surgeon that the ceramic femoral head was shorter by 2mm than other 36mm microport femoral heads. microport's investigation confirmed this complaint and concluded that the microport 36mm ceramic femoral heads have been manufactured to this specification for over 15 years. the main complaint issue associated with this finding would be surgical revision for dislocation or laxity of the hip joint.
  • Acción
    Surgical Specialties is advising surgeons to maintain their usual follow-up protocol and actions for their patients and to ensure that these patients are informed about symptoms (particularly pain, instability, difficulty walking and/or performing common tasks) that indicate the need for revision surgery.

Device

Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short Neck
  • Modelo / Serial
    Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short NeckPart Number: 26000010 Ceramic Femoral Head 36mm SLT Taper Medium NeckPart Number: 26000011Ceramic Femoral Head 36mm SLT Taper Long NeckPart Number: 26000012
  • Manufacturer
    Surgical Specialties Pty Ltd

Manufacturer

Surgical Specialties Pty Ltd