Events

Retiro De Equipo (Recall) de seleXys TH+ and seleXys TPS acetabular shells (acetabular component for the joint hip prosthesis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Mathys Orthopaedics 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-00770-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-14
  • 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-00770-1
  • 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
    Mathys orthopaedics pty. ltd. is issuing this hazard alert for its selexys th+ and tps acetabular shells used in total hip arthroplasty due to higher than expected revision rates. a detailed analysis of the aoa njrr data in april 2015 showed that the individual revision rate of selexys tps acetabular shells was 1.79 revisions per 100 component years and the revision rate of selexys th+ acetabular shells was 4.28 revisions per 100 component years. the analysis of the registry data identified a higher than expected rate of revision due to early loosening/lysis with the selexys th+ and selexys tps acetabular shell.
  • Acción
    Mathys ceased supply of seleXys TH+ and seleXys TPS acetabular shells in Australia in April 2013 and June 2014, respectively. Mathys is recommending that surgeons maintain their routine follow-up protocol for patients who have undergone hip arthroplasty. The majority of additional revisions have been due to loosening/lysis, bone fracture, dislocation and pain. You may wish to consider more frequent or additional follow-up, but revision surgery should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances. For further information, please see https://www.tga.gov.au/alert/selexys-th-and-tps-acetabular-shells-used-hip-replacements . This action has been closed-out on 20/06/2016.

Device

seleXys TH+ and seleXys TPS acetabular shells (acetabular component for the joint hip prosthesis)
  • Modelo / Serial
    seleXys TH+ and seleXys TPS acetabular shells (acetabular component for the joint hip prosthesis)seleXys TH+ Catalogue number range: 55.42.0142 - 55.42.0164seleXys TPS Catalogue number range:: 55.40.0042 - 55.40.0064ARTG number: 122258
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd