Events

Retiro De Equipo (Recall) de REVITAN MODULAR REVISION HIP SYSTEM - DISTAL STRAIGHT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ZIMMER BIOMET CANADA INC..

¿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
    64895
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-01-17
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    This field safety notice is to provide information on the use of the revitan revision system and is jointly provided with the latest updated surgical techniques with references 06.01169.012 and 06.01109.012. zimmer gmbh would like to emphasize that patient selection for modular hip revision systems such as the revitan system is a key parameter. modular stems have been used in revision surgery for many years and provide advantages for issues that are frequently encountered in a revision setting. however a modular system also comes with the risk for potential stem fractures. this is a rare complication of modular revision stems caused most commonly by large stresses to the modular junction when the proximal component lacks medial bone contact at the calcar.45 the risk of stem failure is not unique to any one modular system. bone stock of adequate quality must be present and appraised at the time of surgery. for patients with severe proximal deficiency a surgeon should consider surgical options to ensure proximal bone support (such as medial and/or lateral strut grafts) or switching to a monobloc revision stem such as the wagner sl revision hip stem. please review the indications and contra indications in the associated surgical techniques and instructions for use of the revitan revision system.

Device

REVITAN MODULAR REVISION HIP SYSTEM - DISTAL STRAIGHT
  • Modelo / Serial
    Model Catalog: 01.00405.328 (Lot serial: ALL); Model Catalog: 01.00405.324 (Lot serial: ALL); Model Catalog: 01.00405.322 (Lot serial: ALL); Model Catalog: 01.00405.320 (Lot serial: ALL); Model Catalog: 01.00405.318 (Lot serial: ALL); Model Catalog: 01.00405.316 (Lot serial: ALL); Model Catalog: 01.00405.228 (Lot serial: ALL); Model Catalog: 01.00405.226 (Lot serial: ALL); Model Catalog: 01.00405.224 (Lot serial: ALL); Model Catalog: 01.00405.222 (Lot serial: ALL); Model Catalog: 01.00405.220 (Lot serial: ALL); Model Catalog: 01.00405.218 (Lot serial: ALL); Model Catalog: 01.00405.216 (Lot serial: ALL); Model Catalog: 01.00405.214 (Lot serial: ALL); Model Catalog: 01.00405.124 (Lot serial: ALL); Model Catalog: 01.00405.122 (Lot serial: ALL); Model Catalog: 01.00405.120 (Lot serial: ALL); Model Catalog: 01.00405.118 (Lot serial: ALL); Model Catalog: 01.00405.116 (Lot serial: ALL); Model Catalog: 01.00405.114 (Lot serial: ALL); Model Catalog: 01.00405.014 (Lot serial: ALL); Model Catalog: 01.00405.326 (Lot ser
  • Descripción del producto
    REVITAN MODULAR REVISION HIP SYSTEM-DISTAL STRAIGHT;REVITAN MODULAR REVISION HIP SYSTEM-DISTAL CURVED
  • Manufacturer
    ZIMMER BIOMET CANADA INC.

Manufacturer

ZIMMER BIOMET CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    HC