Events

Retiro De Equipo (Recall) de LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures)

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-01191-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-19
  • 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-01191-1
  • 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 a non-conformance due to a trend analysis showing an incidence of taper lock failures higher than the predicted rate (>0.05%) for four lfit anatomic cocr v40 femoral heads manufactured prior to 2011. the increased incidence of taper lock failures relates to possible taper lock interface inconsistency. potential hazards include disassociation of femoral head from hip stem, fractured hip stem trunnion, increased metallic debris, insufficient range of motion, insufficient soft tissue tension, noise, loss of implant, bone fixation strength, increased wear debris (polymeric), implant construct with a shortened neck length.
  • Acción
    Stryker is advising that patients implanted with an affected lot number of the LFIT Anatomic CoCr V40TM Femoral Heads should continue to be followed per the normal protocol established by his/her surgeon.

Device

LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures)
  • Modelo / Serial
    LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures)Item: 6260-9-236Head diameter 36mm; Offset +5Item: 6260-9-240Head diameter 40mm; Offset +4Item: 6260-9-244Head diameter 44mm; Offset +4Item: 6260-9-340Head diameter 40mm; Offset +8Item: 6260-9-440Head diameter 40mm; Offset +12Item: 6260-9-344Head diameter 44mm; Offset +8Item: 6260-9-444Head diameter 44mm; Offset +12Multiple lot numbers affected ARTG #: 211868
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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