Alerta De Seguridad para Product Name: Hip Arthroplasty System - Hybrid //. Risk class: III (High Risk) //. Technical name: Modular system for total arthroplasty //. Registration number: 10417940085 //. Affected Model (s): Acetabular Insert PHENOM Poly (04.13.13.xxxxx) / Acetabular Insert PHENOM Poly Rear Ceiling (04.13.14.xxxxx) Lot (s): Various //. Products manufactured before 08/25/2016 - Check affected Codes / Batches

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MDT Indústria Comércio Importação e Exportação de Implantes.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1958
  • Fecha
    2016-08-01
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    The MDT recommends: 1. Locating in the company the aforementioned lots and stocking these lots, performing immediate segregation and sending them to MDT, through a Return Invoice; 2. Locate the batches that have been used in the surgical procedure and inform the implantation data, as requested in the Traceability Monitoring. Recommendations to Users and Patients: If there is any adverse event involving the products mentioned in the Collection Action (which can be verified on the Traceability Labels sent to each product), it should be reported to the Distributor and MDT. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    Failure of tolerances between insert and acetábulo, causing micro movements.
  • Acción
    Field Action No. RR112Q- RR017Q- RR085Q- RR087Q triggered under the responsibility of the company MDT Industry Import and Importation Exports Implants. Field Action: Pickup - Return to manufacturer.