Events

Retiro De Equipo (Recall) de M2a 38 Acetabular Cup, M2a 38 Femoral Head, M2a Magnum Tri-Spike Acetabular Cup & M2a Magnum Femoral Heads

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Biomet Australia 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-00100-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-06
  • 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-00100-1
  • 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
    Biomet australia has initiated this hazard alert following analysis of data collected by the australian national joint replacement registry (njrr) which revealed that these specific implants have a higher than expected revision rate when used as part of metal on metal (mom) total conventional hip arthroplasty constructs.Use of these implants has declined since 2008, with the last use of these implants in metal on metal total hip replacements (thrs) recorded in 2011. it is important to note that this hazard alert does not relate to the use of the magnum acetabular cup in combination with the active articulation dual mobility hip bearing system which is a polyethylene/metal construct.
  • Acción
    M2A 38 system and M2a Magnum Femoral Head are in the process of being cancelled from the Australian Register of Therapeutic Goods (ARTG). Surgeons are advised that patients who have received a MoM implant require careful, specific follow up, particularly if the implant is known to have a higher than expected rate of revision as in this case. Biomet is referring surgeons to the 'Recommendations for follow-up of patients with metal-on-metal hip implants' published in the TGA website. For more details, please see https://www.tga.gov.au/alert/biomet-m2a-metal-metal-total-hip-replacement-implants. This action has been closed-out on 03/08/2016.

Device

M2a 38 Acetabular Cup, M2a 38 Femoral Head, M2a Magnum Tri-Spike Acetabular Cup & M2a Magnum Femo...
  • Modelo / Serial
    M2a 38 Acetabular Cup, M2a 38 Femoral Head, M2a Magnum Tri-Spike Acetabular Cup & M2a Magnum Femoral Heads ARTG Numbers: 98098 & 117715
  • Manufacturer
    Biomet Australia Pty Ltd

Manufacturer

Biomet Australia 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