Events

Retiro De Equipo (Recall) de Sterile-Packaged Knee Implants

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-00660-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-19
  • 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-00660-1
  • 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
    An issue has been detected with the foil pouches of specific lots of sterile trabecular metal implants that were manufactured between april 2011 and october 2012. retrospective testing performed by zimmer biomet as a result of an internal review of the packaging system revealed that in some instances, tears/holes in some of the foil pouches were present in either the inner foil pouch or the outer foil pouch, but never both in the same sample. no product complaints have been reported for this issue. the affected product was distributed between april 2011 and march 2016.In a worst case scenario, if an issue with the foil pouch is detected during surgery, this will result in a slight delay to obtain another implant. if there is an issue with the foil pouch that goes undetected and also has resulted in a loss of sterility, a peri-prosthetic infection may occur. the risk associated with a peri-prosthetic infection is a revision or potential multi-stage revision to treat the infection.
  • Acción
    Peri-prosthetic infections associated with the device/surgical site are most likely to manifest within 12 months of the device being implanted. Zimmer is advising surgeons to review the notification and ensure affected personnel are aware of the contents. This action has been closed-out on 27/01/2017.

Device

Sterile-Packaged Knee Implants
  • Modelo / Serial
    Sterile-Packaged Knee Implants Part Numbers: 00-5878-065-35, 00-5878-065-41, 00-5886-043-12, 00-5886-043-14, 00-5886-045-12, 00-5886-047-17, 00-5886-048-12, 00-5886-056-10, 00-5886-064-12Multiple Products and Lot Numbers affectedARTG Numbers: 227807, 228177, 226498
  • 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