Events

Retiro De Equipo (Recall) de Zimmer Segmental System Polyethylene Insert-Size B & Size C (Intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration)

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-2014-RN-00111-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-05
  • 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-2014-RN-00111-1
  • 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 has received 13 complaints since 2007 related to hyper-extension. this represents a complaint rate of approximately 0.4%. of the 13 complaints there were 9 patients involved due to repeat occurrences with multiple patients. in addition, analysis of the explanted polyethylene insert found that it typically exhibited anterior deformation in these 9 patients. based on the investigation of these complaints, zimmer determined that updates to the labelling associated with the zimmer segmental system were required to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
  • Acción
    Zimmer is updating the applicable surgical technique (97-5850-004-00) and instructions for use (87-6203-755-23) and is advising surgeons that if a patient is symptomatic with instability or pain associated with hyperextension of approximately 15 degrees or more, surgeon evaluation is recommended. Zimmer is also working on an enhanced design that will be offered in addition to the current polyethylene inserts.

Device

Zimmer Segmental System Polyethylene Insert-Size B & Size C (Intended to replace the proximal fem...
  • Modelo / Serial
    Zimmer Segmental System Polyethylene Insert-Size B & Size C (Intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration) Item Numbers: 00-5850-012-95 & 00-5850-013-95ARTG Number: 198424
  • 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