Events

Retiro De Equipo (Recall) de Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag)

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-2013-RN-00985-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-25
  • 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-2013-RN-00985-1
  • 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
    Residue or pieces of film from the ldpe bag containing the implant may adhere to the highly polished implant surface. the frequency of this occurrence is approximately 1 in 8000 cases. in a small number of these cases the affected device was implanted. testing and analysis were conducted to evaluate potential risks such as abrasive wear, mechanical integrity and biocompatibility. these evaluations concluded that it is unlikely that adhesion of the ldpe bag would cause an adverse effect to either the patient or function of the implant because:-the ldpe material is biocompatible, similar to the ultra high molecular weight polyethylene (uhmwpe).-ldpe is softer than the two mating material of uhmwpe & cobalt chrome molybdenum. therefore, is not expected to scratch either wear surface, which could increase wear rates and lead to osteolysis.-if there were wear particulates generated from the ldpe bag, they would be expected to elicit similar reactions as those from uhmwpe.
  • Acción
    Zimmer is advising users to examine potentially affected implants prior to use. Should a user encounter adhesion of a LDPE bag to a implant during surgery, it is recommended that the implant not be used. The implant can be returned to a Zimmer sales representative.

Device

Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag)
  • Modelo / Serial
    Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag)All lots manufactured prior to 1 April 2013Multiple products affectedMultiple Part Numbers affectedARTG Numbers: 95692, 208688, 99906, 95760, 115909
  • 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