Alerta De Seguridad para 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

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.

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.