In June 2018, Smith & Nephew issued a Field Safety Notice warning that its first-generation Journey BSC knee system has a higher than expected risk of revision due to early femoral and tibial insert component loosening.
Component loosening was identified a main cause of device failure.
The company said as part of its post-market surveillance and post-marketing clinical follow-up processes, it conducted an analysis of the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry.
The data indicate that the system had a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates in the two registries.
The company issued the field safety corrective action to regions where the first-generation Journey BCS, introduced in 2005 was used, advising individuals to phase out first-gen components and warning of the higher revision rate.
On July 23, 2018, the UK’s national health service, Medicines and Healthcare products Regulatory Agency, recommended against implanting the device and said physicians should monitor patients with the implant for the first five years post-implantation and then every two years to ten years post-implant, and then report any adverse events.
The National Joint Registry of England, Wales and Northern Ireland 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. However, the company is telling surgeons to maintain their routine follow-up protocol for patients who have undergone total knee arthroplasty with the system.
“Signs and symptoms to consider for a potential revision are no different from those that might be reported by any patient having undergone primary total knee arthroplasty. The need for revision should be determined on a case-by-case basis following a detailed assessment of each patient’s clinical circumstances,” stated the field notice.
The Journey II BCS Knee system is not subject to the notice.
