Events

Retiro De Equipo (Recall) de Total Hip Software Application 3.1 & 3.1.1 for use with 3.0 Mako system (Robotic surgical navigation system used during total hip arthroplasty)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2016-RN-01315-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-13
  • 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-01315-1
  • 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
    Stryker has identified an issue with the tha 3.1 and tha 3.1.1 software which may cause the surgeon to experience a feeling of vibration in the robotic arm during acetabular preparation. should vibration occur, the surgeon may need to reposition the arm during reaming of a planned cup position which may result in complications associated with extended surgery time of less than 15 minutes. the occurrence of this vibration will be corrected through the installation of an upgraded software version tha 3.1.1.1 on the mako system.
  • Acción
    Stryker is advising users to inspect inventory for affected products. Users with affected product will be contacted by Stryker who will coordinate the installation of a software update as a permanent correction. In the interim, users can continue to use the affected product and mitigate the risk of vibration by following the instructions on the User Guide (PN 210555 – THA 3.1 Application User Guide, PN 212026 – THA 3.1.1 Application User Guide) and Surgical Technique (PN 210558 – THA 3.1 Surgical Technique, PN 212027 – THA 3.1.1 Surgical Technique) for proper pin placement/ securement, recommended Mako system setup and patient securement. This action has been closed-out on 18/05/2017.

Device

Total Hip Software Application 3.1 & 3.1.1 for use with 3.0 Mako system (Robotic surgical navigat...
  • Modelo / Serial
    Total Hip Software Application 3.1 & 3.1.1 for use with 3.0 Mako system (Robotic surgical navigation system used during total hip arthroplasty)Item Numbers: 212212-01, 212212-03, 212212-99, 212212, 212103-01, 212103-03, 212103-99, 212103, 212110, 212100-01, 212100-03, 212100, 212220-01, 212220-03, 212220, 212042, 212034, 212239, 212240, 212243, 212244 (Kits that include software) ARTG Number: 223106
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA