Events

Safety Alert for Trade name: Vanguard PS Knee System. Technical Name: Total Knee Prostheses. ANVISA registration number: 80044680074. Risk class: III. Model affected: 00 000 000 1831 28. Serial numbers affected: J3798251; J3847223

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biomet 3I do Brasil Comércio de Aparelhos Médicos Ltda.; Biomet Orthopedics, Inc..

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
    2344
  • Date
    2017-08-01
  • 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
    As the products have not reached users and patients, no recommendation is needed. The distributor has already been informed and is taking the necessary actions. 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 - Date of identification of the problem by the company: 07/14/2017 - Date of notification notice to Anvisa: 08/01/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Reason
    Zimmer biomet is conducting a very specific recall of medical devices for vanguard open posterior stabilized femoral components due to the inadequate labeling of some components between april 5, 2016 and september 1, 2016. as a result, the packaging of some femoral components was incorrectly labeled with smaller or larger size and / or wrong side (right / left). at the moment of use, it is easy to detect the incorrect label, since the product has correct laser marking. the estimated occurrence rate is <1 in 1,000 products.
  • Action
    Field Action Code 2017-274 triggered under the responsibility of Biomet 3I of Brasil Comércio de Aparelhos Médicos Ltda. It will make collection for return to the manufacturer.

Device

Trade name: Vanguard PS Knee System. Technical Name: Total Knee Prostheses. ANVISA registration n...

Manufacturer

Biomet 3I do Brasil Comércio de Aparelhos Médicos Ltda.; Biomet Orthopedics, Inc.
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “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
    ANVSANVISA