Events

Retiro De Equipo (Recall) de SIGMA HP PFJ Cemented Trochlear 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 Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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-2018-RN-00005-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-09
  • 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-2018-RN-00005-1
  • 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
    The manufacturer, depuy orthopaedics, inc. is voluntarily recalling the sigma hp pfj cemented trochlear implants, which is a standalone component of the partial knee system. this decision is based on elevated revision rates observed as part of the company’s post market surveillance process. further distribution or use of the affected implants is to cease immediately, and the product is now discontinued. the company recommends that surgeons use alternative implants or consider a total knee replacement.
  • Acción
    DePuy is advising Recipients are requested to return a copy of the completed acknowledgement form as directed in the Hazard Alert and to forward this notice to anyone who needs to be informed. DePuy Orthopaedics, Inc. is not recommending prophylactic revision in the absence of symptoms. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients who received the affected implants.

Device

SIGMA HP PFJ Cemented Trochlear Implants

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes