Medical device alert issued for the First Generation JOURNEY BCS Knee System produced by Smith Nephew
Smith & Nephew issue medical device alert on prosthetic knee
Posted on 25 July 2018
On 23 July 2018 the MHRA issued a Medical Device Alert (MDA/2018/026) to all NHS Trusts across the UK instructing them to cease implanting a prosthetic knee system produced by Smith & Nephew, and to monitor all patients implanted with these devices 'for signs of loosening'.
The device is known as the First generation JOURNEY BCS Knee System a prosthetic knee system first introduced to the market in 2005. In correspondence directed at orthopaedic surgeons, Smith & Nephew, the company behind the device advised, 'our analysis of available post-market surveillance data suggests that patients that have been implanted with a first generation JOURNEY BCS Knee System have a higher risk of requiring a revision earlier than they or their surgeon had expected'.
The MHRA have issued this Medical Device Alert on the basis of data produced by national joint registries in the UK and Australia, which are relied upon by Smith & Nephew and other medical device companies to monitor the performance of their products after they are implanted into patients. According to the MHRA alert that data showed that the system had a revision rate that was double the average revision rate of other prosthetic knee systems.
Zahra Nanji, a lawyer in the Leigh Day product liability team commented, 'this latest MHRA alert will be particularly worrying for patients who have already been implanted with this component and who will now be left wondering whether or not they will have to undergo early revision surgery. Having a prosthetic device inserted often involves a major operation and a sustained period of recovery. Data in relation to other orthopaedic products suggests that early revision of prosthetic devices can increase the risk that the patient will need additional revisions in the future, that means a patient may have to undergo multiple operations to replace devices that she had reasonably expected would last much longer'.
If you have been implanted with this device and have undergone a revision within the last three years, or are have been advised that you are likely to undergo a revision in the future, please get in touch.