The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates the safety of medical devices in the UK, has issued an alert notifying healthcare providers and orthopaedic surgeons that the Smith & Nephew JOURNEY BCS knee replacement system has significantly higher failure rates than comparable systems.
The affected product is the first generation JOURNEY BCS, which is a prosthetic knee construct manufactured by Smith & Nephew. The manufacturer issued a notice in June 2018 after surveillance of the post-implantation data suggested that patients fitted with the components were at risk of needing revision surgery earlier than they or their surgeon had expected. Smith & Nephew confirmed that the most common cause of failure of the knee construct was joint loosening, which is a known and recognised complication of conventional knee replacement systems, but was occurring at higher rates and earlier in this model than with comparable systems.
In the UK, statistics on the National Joint Registry show that revision rates for the JOURNEY BCS construct are more than double the average rate for standard primary total knee replacements. This essentially means that patients who were fitted with the JOURNEY BCS are at a 50% greater risk that their knee replacement will fail early, than if they had been fitted with a conventional knee replacement construct.
It is noted in the alert that Smith & Nephew does not recommend revision of the joint, but that healthcare providers place patients under more regular review so that, if they begin to exhibit signs of loosening, they are able to undergo revision surgery as soon as it is required.
Arran Macleod, an associate in the product liability team at Penningtons Manches, said: “Not every patient who undergoes a total knee replacement will have a perfect outcome. Some will experience early loosening of the joint, which will cause their knee to feel unstable. This is a known and recognised complication of the procedure and will often require revision surgery sooner than the patient anticipated. In many cases, where the device is sound and there was no negligence in the way in which surgery was performed, this is an unfortunate but recognised outcome.
“With this knee component, however, the risk of early failure and the requirement for early revision is 50% higher than that of a conventional knee replacement. If the knee system is found to be defective, then patients who require premature knee replacement surgery may have a right to claim compensation from the manufacturer.