Retiro De Equipo (Recall) de NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 specific lots already implanted due to the potential that the threads may be out of specification. zimmer received twelve complaints over a period of two and a half years alleging difficulty threading an mis drop down stem extension or a drop down stem plug into the mis stemmed tibial component. there were no complaints received from australia. the potential risks for this issue are: · additional bone loss may occur if the mis tibial is cemented in place when the issue is identified and the surgeon elects to remove and replace.· early revision may occur due to loosening (if the mis stemmed tibial component is implanted without a drop down stem extension), and/or infection.· disassociation of the implanted articular surface may occur if the stem extension does not fully seat, thus causing the articular surface to not properly lock.
  • Acción
    Zimmer is providing surgeons with details of the potential risks associated with out of specification thread. For patients implanted with a potentially affected device, Zimmer recommends continued normal post-operative follow-up. For more details, please see .


  • Modelo / Serial
    NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, PrecoatVarious sizes ARTG Number: 96761
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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