Events

Safety Alert for Metal-metal prostheses

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/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
    1230
  • Date
    2013-02-07
  • 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
    1. The ANVISA Technovigilance Unit is following the discussions; 2. the registry holders of products in Brazil were contacted, who informed that they did not receive complaints involving their products; 3. The NOTIVISA database, adverse event notification or technical complaint involving this technology has not been included so far; 4. Publication available on the FDA website on the internet reinforces some of the care already applied to patients who need implants or who have undergone orthopedic implant surgeries: (i). To choose the type of implant, a physician should choose to use a metal-to-metal hip implant only after determining that the benefit-risk of using one metal to metal exceeds the use of another type of technology; (ii). Patients implanted should be monitored periodically, through physical and imaging exams; (iii). The decision to review a metal-to-metal hip implant should be made according to the patient's clinical situation.
  • Reason
    News published by foreign bodies, including regulators, point to the possibility of adverse events associated with the use of metal-metal prostheses. the friction of the metal can cause particle release and consequent wear of the device and thus cause damage to the surrounding bone and / or soft tissues. such damage can result in pain, loosening of the implant and need for surgical revision procedure. it is also being raised the possibility of release of ions into the bloodstream, which would cause systemic damage. according to the fda, there is currently insufficient scientific data to specify the concentration of metal ions in a patient required to produce systemic adverse effects. in addition, the reaction appears to be patient-specific.
  • Action
    SAFETY ALERT

Device

Metal-metal prostheses
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA