Events

Safety Alert for Trade name: Comp. Femoral Cementate Technical Name: Implantable Material ANVISA Registration Number: 10417940046 Hazard Class: III Model Affected: Femoral Modular III Component Right Affected Series Numbers: 00219S and 00202S

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MDT Industria Comércio Importação e Exportação de Implantes S.A.; MDT Industria Comércio Importação e Exportação de Implantes S.A..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2272
  • Date
    2017-04-19
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Non-deployed products should be segregated and returned to the MDT company. We recommend to users and patients that there are some technical complaints and adverse events involving the products mentioned in the Field Action (which can be verified on the Traceability Labels sent to each product), the Distributor and the MDT Manufacturer and / or through the NOTIVISA System. To the users, it is confirmed that clinical follow-up of patients already implanted is not necessary, since possible failures are perceptible during the implantation procedure, making it possible to substitute the product and / or make the surgery unfeasible.
  • Reason
    When the product was opened it was identified that it was a modular female component iii medium and not a modular female modular component iii as described in the internal and external labels.
  • Action
    Field Action Code AC 02.2017 triggered under the responsibility of the company MDT Industria Comércio Importacao e Exportação de Implantes SA Company will make collection for later return to the manufacturer.

Device

Trade name: Comp. Femoral Cementate Technical Name: Implantable Material ANVISA Registration Numb...

Manufacturer

MDT Industria Comércio Importação e Exportação de Implantes S.A.; MDT Industria Comércio Importaç...