Alerta De Seguridad O Notificaciones De Seguridad para First generation JOURNEY BCS Knee System– Higher than expected risk of revision (MDA/2018/026)

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.

In June 2018, Smith & Nephew issued a Field Safety Notice in relation to the first generation JOURNEY BCS femoral and tibial insert components informing healthcare professionals that the knee system has a higher than expected revision rate. Component loosening has been identified a main cause of device failure.The National Joint Registry of England, Wales and Northern Ireland (NJREWNI) shows the revision rate for the affected device is more than double the average rate for primary total knee replacements. The first generation JOURNEY BCS femoral knee components were phased out globally in 2013-14 and are no longer available for sale.Smith & Nephew is not recommending pro-active revision surgeries for patients implanted with this device.MHRA sought expert clinical advice and recommends all patients should be monitored for signs of device loosening.