Events

Retiro De Equipo (Recall) de Global Cup Poly Liner, Neutral prostheses(part of the Global Cup Acetabular 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 Global Orthopaedic Technology 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-01262-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-22
  • 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-01262-1
  • 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
    Global orthopaedic has become aware that certain lots of the global cup poly liner, were manufactured with an internal diameter whose tolerance did not conform to iso 7206-2:2011.According to iso 7206-2, the spherical socket of global cup poly liner, shall have an internal diameter equal to the nominal diameter within a tolerance of +0.10mm to +0.30mm. the affected lots were manufactured with an internal diameter equal to the nominal diameter within a tolerance of +0.02mm to +0.07mm. whilst oversized relative to the nominal diameter of the femoral head, the internal diameters of the product have the potential to alter torque and/or wear rates when articulating against the femoral head, potentially leading to early mechanical loosening or loosening over time due to osteolysis.Post-market surveillance has not indicated any clinical or biomechanical evidence to suggest that they are associated with an increased risk of loosening, lysis or revision.
  • Acción
    Global Orthopaedic is informing implanting surgeons to consider the provided information during follow up for relevant patients.

Device

Global Cup Poly Liner, Neutral prostheses(part of the Global Cup Acetabular System)
  • Modelo / Serial
    Global Cup Poly Liner, Neutral prostheses(part of the Global Cup Acetabular System)Part Number: GM09002-207-xxMultiple Products and Lot NumbersARTG Number: 218814
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd