Events

Retiro De Equipo (Recall) de Vaios Total Shoulder Replacement System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Orthotech 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-00976-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-15
  • 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-00976-1
  • 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
    The tga has cancelled the vaios total shoulder replacement system, sponsored by orthotech, from the australian register of therapeutic goods (artg) due to a higher than expected revision rate. information published by the australian orthopaedic association’s national joint replacement registry (aoanjrr) indicated that the vaios total shoulder replacement system had a revision rate at two years of 17.6%. the comparable revision rate for all other total conventional shoulder implants was 5.5% at two years. the main reasons for revision were instability/dislocation, rotator cuff insufficiency and loosening/lysis.
  • Acción
    Orthotech are advising clinicians to consider contacting patients who have been implanted with these devices to inform them of this issue. Implanting surgeons are advised to maintain their routine follow-up protocol for patients who have undergone shoulder arthroplasty. The need for any additional follow-up or revision surgery should be determined on a case-by-case basis following a detailed assessment of the patient’s clinical circumstances. This action has been closed-out on 29/08/2016.

Device

Vaios Total Shoulder Replacement System
  • Modelo / Serial
    Vaios Total Shoulder Replacement SystemARTG Number: 173236
  • Manufacturer
    Orthotech Pty Ltd

Manufacturer

Orthotech Pty Ltd