You may have heard about a recall of some types of Zimmer NexGen knee implant. What does this mean and, if you’ve had a knee replacement at our Gloucestershire knee clinic, are you affected?
Let’s address the most important part of this story first: if I’ve performed your knee replacement – whether that has been as an NHS patient or as part of private knee surgery in Cheltenham, Gloucester or the Cotswolds – you haven’t received the affected implant combination. There’s no need to worry and there’s nothing further you need to do.
Across Gloucestershire, however, around 120 patients have had the affected combination of components used in their knee replacement. So how are they affected?
Zimmer NexGen – what’s the problem?
Total knee replacement is one of the most commonly performed orthopaedic procedures. During the procedure, a metal component is placed at the end of the femur (thigh bone) and a metal implant with plastic insert is placed on top of the tibia (shin bone). Several different companies produce total knee replacement implants. All knee replacement implants are recorded on a national database to audit performance (the National Joint Registry).
The Zimmer NexGen knee replacement is a common knee replacement. It has been used extensively in Gloucestershire and globally for several years. The 19th National Joint Registry (NJR) report records that 183,105 NexGen implants have been implanted in total, with a 10-year revision rate (that is, the number of implants which need ‘fixing’ or replacing within 10 years) of 3.38 (2.27-3.49). This compares favourably with other implants’ 10-year survival rates.
It’s important to note, however, that the NexGen is a ‘family’ brand of implants. That means there are lots of implant options which may be combined to form the complete replacement knee joint. Your knee surgeon will choose four components depending on patient specific factors (for example, height and gender/build) out of a potential 88. Each different component is recorded on the NJR, giving the NexGen several different revision rates within the overall family.
A recent statement from BASK (the British Association for Surgery of the Knee) highlighted an issue with one specific type of component (‘Option Tibial Components’) when used in combination with two others (the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Femoral (GSF) Option Femoral).
These components used in combination led to an increased revision rate compared to other total knee arthroplasties in the UK NJR. The Option Tibial Components are being recalled. The LPS Flex femoral components are being kept under review.
So where does that leave us?
To be clear, I have used the NexGen system in the past, but I haven’t used the affected subset of components in combination. Evidence compiled over many thousands of procedures indicates no issue with the remaining NexGen family.
Even if you’ve had the affected NexGen implant components as part of your knee replacement, it doesn’t mean you are likely to experience problems. In fact, you remain unlikely to experience any issues, although that likelihood is a little less than it ideally should be. Locally, our evidence doesn’t indicate patients are experiencing a higher failure rate.
Nevertheless, every affected person has received a letter explaining that they are at higher risk of revision, with further advice on next steps. As part of my NHS work I’m actually leading the recall on NexGen in Gloucestershire.
Alternative knee replacement implants
Aside from this very specific combination, there really does appear to be no issue with this family of implants, but I can’t pretend that it hasn’t been on the minds of some patients who visit my Cheltenham knee surgery. The Zimmer NexGen may not have a clinical issue with its wider family of implants, but it’s just possible it may have a rather unfair PR issue.
For that reason (and also because they are excellent implants) I now use DePuy products (specifically the Attune and PFC, the latter of which has 20 years of evidence supporting it). DePuy is part of Johnson & Johnson.
Next steps if you have had a NexGen knee implant
So what should your next steps be if you’ve had the specific NexGen implant affected by the recall? The simple answer is to do nothing because the chances are you won’t experience any issues. If you don’t know what implant you received, you will have been contacted if you had the affected models.
If you are experiencing problems, however – or if you are worried – please contact the hospital at which you had your operation and they will take the matter from there.
And just to reiterate, if I performed your knee implant – on the NHS or privately – you haven’t had the affected implant combination. I usually will, however, have sent a letter to your GP detailing the implant I did use, so if you’re unsure, give your GP a call.
Book your appointment at my Cheltenham hip and knee clinic now or call 01242 246549.