Events

Retiro De Equipo (Recall) de NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Zimmer 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
    55876
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2415-2010
  • Fecha de inicio del evento
    2010-04-26
  • Fecha de publicación del evento
    2010-09-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92124
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    The firm has received complaints of loosening of the implanted device requiring revision surgery. there have been 114 mdrs filed all reported that the device loosened and the patient required additional surgery to replace the device.
  • Acción
    The firm, Zimmer, Inc., sent an "URGENT DEVICE CORRECTION" letter dated April 26, 2010, to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to destroy or disregard all previous versions of the surgical technique, review the attached revised surgical technique to familiarize yourself with the modifications and warnings, and complete and return the Health Care Professional Dcoumentation Form via fax to Zimmer, Inc. at (574) 372-4265. (Note: Zimmer made a modification to the surgical technique and instructions for use. They added a warning to fully cement and pressurize the anterior and posterior surfaces of the tibial component, and to strongly recommend the use of a drop down stem extension. This change was completed and approved on April 23, 2010.) For questions please contact Zimmer at 1-877-946-2761.

Device

NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS
  • Modelo / Serial
    103044, 60276808, 60282368, 60292625, 60296123, 60296124, 60307227, 60315651, 60328159, 60331388, 60331389, 60339651, 60343929, 60343930, 60343931, 60343932, 60343933, 60343934, 60343935, 60355713, 60362083, 60365658, 60384329, 60534175, 60570899, 60578778, 60584754, 60616292, 60625488, 60640829, 60692575, 60727493, 60760516, 60818767, 60867946, 60892877, 60917518, 60955232, 60983707, 61113641 and 61143803
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.
  • Descripción del producto
    NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 8, sterile, REF 00-5950-057-02, Zimmer Inc. Warsaw, IN. || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Dirección del fabricante
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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
    USFDA