Events

Retiro De Equipo (Recall) de Persona Trabecular Metal Tibial Plate, all sizes

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-2015-RN-00199-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-18
  • 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-00199-1
  • 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
    Zimmer is initiating a hazard alert for the persona trabecular metal™ tibial plate as the current complaint rate (0.61%) for radiolucent lines and loosening is higher than zimmer’s expectations and experience based on zimmer’s similar devicesout of the 0.61% complaints received, 36% identified symptomatic radiolucent lines or were revised for loosening, 28% identified asymptomatic radiolucencies, 8% subsided, and 28% were inconclusive. aseptic loosening of cementless tibial implant components is one of the most prevalent causes for revision in total knee arthroplasty and a number of factors may contribute to the loosening failure mode, including patient characteristics, rehabilitation protocol and compliance, surgical technique, and product features. there have been no revisions or reports of radiolucency lines or loosening in australia.
  • Acción
    Surgeons are advised to follow-up with patients implanted with Persona Trabecular Metal Tibial Plate and also continue their normal post-operative follow -up routine. For additional information please see https://www.tga.gov.au/alert/persona-trabecular-metal-tibial-plate-used-knee-replacements . This action has been closed-out on 18/07/2016,

Device

Persona Trabecular Metal Tibial Plate, all sizes
  • Modelo / Serial
    Persona Trabecular Metal Tibial Plate, all sizes Part Numbers:42-5300-064-01, 42-5300-067-01, 42-5300-071-01, 42-5300-075-01, 42-5300-079-01, 42-5300-083-01, 42-5300-088-01, 42-5300-064-02, 42-5300-067-02, 42-5300-071-02, 42-5300-075-02, 42-5300-079-02, 42-5300-083-02 & 42-5300-088-02ARTG number: 222393
  • 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