Smith & Nephew issued an Urgent Field Safety Notice affecting first-generation JOURNEY BCS femoral and tibial insert components manufactured in Tennessee. The notice does not affect the JOURNEY II BCS Knee.
The affected devices were introduced in 2005 and phased out through 2013 and 2014. Review of postmarket surveillance data on the device prompted the notice, as it suggested that patients with the system may have a higher risk of revision than previously expected. Specifically, data indicate that the system has a revision rate over 1.5x the primary total knee arthroplasty device class average rates in two registries, National Joint Registry of England, Wales and Northern Ireland and the Australian Orthopaedic Association National Joint Replacement Registry.
The femoral components are under voluntary removal, while the tibial inserts are under advisory notice; the latter remains available for use under specific conditions. Smith & Nephew is not recommending proactive revision surgeries for patients implanted with this device, though MHRA recommends that all patients should be monitored for signs of device loosening.
Sources: Safety Notice; MHRA Alert