Events

Alerta De Seguridad O Notificaciones De Seguridad para Bone Cement

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Biomet.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Fecha
    2018-04-20
  • Fecha de publicación del evento
    2018-04-20
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/bone-cement-optipac-40-refobacin-revision-and-optipac-80-refobacin-revision-risk-of-revision
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
    In December 2017 Biomet issued a Field Safety Notice informing healthcare professionals that the mechanical strength of the affected batches of bone cement may be reduced increasing the risk of revision. There is also a risk of prolonged surgery from increased polymerisation time when using affected batches of bone cement. The manufacturer suggests it would be prudent to monitor closely affected patients as part of their standard follow-up.This Medical Device Alert is being issued to ensure that all hospitals are aware of the issue and that adequate action is taken to mitigate potential risk to patients.
  • Causa
    Manufactured by biomet – risk of revision surgery from an increase in bone cement polymerisation time and reduced mechanical strength.
  • Acción
    Identify and quarantine all affected devices. (See table below for affected batches.) Follow actions recommended in the manufacturer’s Field Safety Notice. If at time of use the setting time was longer than indicated in the manufacturer’s instructions for use these patients may require more frequent follow up. For all affected patients, surgeons will need to formulate a local risk assessment and follow-up plan based upon the length of time the device was in storage and relevant patient variables. The affected batches are known to have their mechanical strength reduced by half after 6 months in storage. Complete the certificate of acknowledgment attached to the Field Safety Notice and return it to the manufacturer.

Device

Bone Cement
  • Modelo / Serial
  • Descripción del producto
    Catalogue number (Manufacturer product code) Product Description Batch/Lot number Use-by date Date of manufacture OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A648C04670 31/05/2018 19/12/2016 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A648C05100 30/06/2018 09/01/2017 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A705B05130 31/07/2018 09/02/2017 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A705B06130 30/09/2018 04/04/2017 OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A722B08920 30/11/2018 20/06/2017 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A620A01788 31/01/2018 16/08/2016 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A620A0178A 31/01/2018 23/08/2016 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A705C05628 31/08/2018 30/03/2017 OPTIPAC 80 REFOBACIN REVISION 4732501165-1 B705B05128 31/07/2018 09/02/2017
  • Manufacturer
    Biomet

Manufacturer

Biomet
  • Dirección del fabricante
    Zimmer Biomet UK Ltd Peter Bevan Email: Peter.Bevan@zimmerbiomet.comTel: +441656674270 Mobile: +447920007446Peter.Bevan@zimmerbiomet.com
  • 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
    MHRA