Events

Safety Alert for Stryker Femural Head. Registro Anvisa n ° 80005430072. Affected Codes and lots: See Product manufacturer's Alert Message, available at: http://portal.anvisa.gov.br/wps/wcm/connect/74cdfe004a8e435f8a73bb486c3ae08b/Carta+Cliente+RA+2014 -170.pdf? MOD = AJPERES

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by STRYKER DO BRASIL LTDA.; STRYKER ORTHOPAEDICS MAHWAH/HOWMEDICA OSTEONICS CORP..

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
    1722
  • Date
    2015-11-12
  • 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
    Failure detected on the product may cause improper functionality, excessive or insufficient strain on soft tissue, as well as lead to metal debris from metal wear and / or corrosion of the material. Such problems can cause surgical complications, loss of mobility, reduced range of motion, joint instability, inflammatory response, pain and adverse reactions associated with the implant. A difficulty in inserting the femoral head into the shaft may also cause a surgical delay of approximately 15 minutes.
  • Reason
    Risk of femoral heads not being properly inserted into the stem neck, or causing an inadequate locking force between the femoral head and the stem neck.
  • Action
    Product pickup by the record holder. Products at risk should not be used. Check your inventory and segregate the products at risk as soon as possible, identifying them to avoid inadvertent use.

Device

Stryker Femural Head. Registro Anvisa n ° 80005430072. Affected Codes and lots: See Product manuf...

Manufacturer

STRYKER DO BRASIL LTDA.; STRYKER ORTHOPAEDICS MAHWAH/HOWMEDICA OSTEONICS CORP.
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    ANVSANVISA