Events

Retiro De Equipo (Recall) de Avenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard uncemented (used as the component in total hip arthoplasty)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Zimmer 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-00928-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-12
  • 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-00928-1
  • 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 avenir müller stem 6 lateral uncemented may have been placed in the packaging of the avenir müller stem 4 standard uncemented and vice versa.The surgeon may have used a standard stem instead of a lateral stem. for the standard stem the offset is 6mm smaller and therefore an increased laxity of the hip might result. this could conduct to a risk of luxation, pain or revision surgery.
  • Acción
    Zimmer is advising users that use of a standard stem instead of a lateral stem may result in an increased laxity of the hip, and may result in pain or revision surgery. This action has been closed-out on 17/02/2017.

Device

Avenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard uncemented (used as the...
  • Modelo / Serial
    Avenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard uncemented (used as the component in total hip arthoplasty)Avenir Müller Stem 6 Lateral uncemented Reference Number: 01.06010.106Lot Number: 4023094Avenir Müller Stem 4 Standard uncementedReference Number: 01.06010.004Lot Number: 4022860ARTG Number: 216175
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA