Events

Retiro De Equipo (Recall) de Active Knee Total Knee Replacement System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Allegra Orthopaedics Limited.

¿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-01395-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-21
  • 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-01395-1
  • 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
    Review of the australian orthopaedics association's national joint replacement registry (aoanjrr) data shows that the active femoral component used with (cemented or cementless) active knee tibial component has a higher revision rate than expected when compared to similar implants. a large number of the revisions were due to patella breakage. further analysis of the information held by aoanjrr indicates that use of the active knee total knee replacement prosthesis without patella resurfacing at the time of primary surgery may lead to increased risk of patella erosion and patella-femoral pain.
  • Acción
    The following advice is provided to surgeons who have used Active Total Knee Replacements to ensure continued safe use and proper patient management. For prospective patients: - It is strongly recommended that patella resurfacing is performed when the Active Total Knee replacement femoral components are used. - Use of the Active Femoral Component otherwise may proceed as normal. For patients who have received the Active Femoral Component without patella resurfacing: - Asymptomatic patients do not require surgical intervention as a result of this alert. - Particular consideration for the increased risk of patella erosion and patella-femoral pain will need to be paid to patients at follow-up visits. - The surgeon may consider more careful or frequent follow-up.

Device

Active Knee Total Knee Replacement System
  • Modelo / Serial
    Active Knee Total Knee Replacement SystemActive Knee (Cemented) Femoral ComponentCatalogue # 10-1521-0342 to 10-1522-0270, 10-1513-0500 to 10-1513-0509ARTG # 217122, 217127Active Knee (Cementless) Tibial ComponentCatalogue #10-1521-0302 to 10-1522-0230, 10-1513-0400 to10-1513-0409ARTG # 133900, 217128Active Knee PatellaCatalogue # 10-1514-0750 to 10-1514-0754ARTG # 217306Active Knee Knee Insert/BearingCatalogue # 10-1533-0080 to 10-1533-0275ARTG # 217305, 217297
  • Manufacturer
    Allegra Orthopaedics Limited

Manufacturer

Allegra Orthopaedics Limited