Events

Alerta De Seguridad O Notificaciones De Seguridad para Kinemax Plus Revision TS Tibial Inserts

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 manufacturer #17429.

¿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
  • ID del evento
    MDA/2008/066
  • Número del evento
    CON025818
  • Fecha
    2008-09-18
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON025818
  • 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
  • Causa
    Risk of loosening, excessive wear and fracture of knee replacement components, due to a manufacturing defect. patients with revision knee replacements may have received a tibial insert with a manufacturing defect. the affected devices have an incorrectly machined stabiliser post recess, which prevents the tibial insert from fitting correctly over the stabiliser post. the manufacturer has contacted all uk users to recall the affected devices (see the manufacturer’s field safety notice in appendix). 112 affected devices were distributed in the uk. as a result of the recall, 73 unused devices have been returned to the manufacturer. the remaining 39 devices may have been implanted in patients. patients who have received these implants are at risk of loosening, excessive wear and/or fracture of components. these could be caused by any of the following reasons: the gap between components was not detected during assembly excessive force was required to seat the insert with the base plate a smaller stabiliser post from a smaller sized insert was used to complete the surgery.
  • Acción
    Do not implant affected devices Identify any affected stock that has not been implanted, and return to manufacturer Follow the patient management recommendations in this alert. Do not implant affected devices Identify any affected stock that has not been implanted, and return it to the manufacturer Identify which patients have been implanted with affected devices Ensure that affected patients, including those without symptoms, are followed up in accordance with usual standards of care for revision knee replacement patients (the manufacturer recommends follow-up at 6 weeks, 6 months, 12 months, and annually thereafter) Advise patients implanted with affected devices to report any increasing pain, or any symptoms of knee instability such as clicking Consider the need for revision for symptomatic patients.

Device

Kinemax Plus Revision TS Tibial Inserts
  • Modelo / Serial
  • Descripción del producto
    Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts (specific product and lot codes – see Appendix in pdf only).
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429