NexGen knee replacement: Latest development and what this means for patients

Written by Emma Blackburn, Trainee Solicitor in our Harmful Products department.

The NexGen Knee Replacement is a total knee replacement component manufactured by Zimmer-Biomet. It is made up of three sections; the femoral component, the polyethylene insert, and the tibial tray which together form the complete component that is implanted into the patient’s knee and secured with bone cement.

The implant, which is one of the most popular used in the United Kingdom, was introduced in its first form in 1995, and has been widely used in both NHS and private practice since. In late 2022, the implant was the subject of a manufacturer’s voluntary recall following concerns over the loosening of the implant when certain components were used in specific combinations with each other. It has since been identified that the issue relates to certain tibial components when used together with certain femoral components.

Since then, patients across the United Kingdom have received recall letters suggesting that they return to their original implanting clinics for investigation as they may have received a defective combination of devices. Many patients have found themselves in severe pain and having to undergo further remedial treatment, including early revision surgery.

BBC “File on 4 Investigates”

In August 2025, the BBC shed some further light on this issue through their “File on 4 Investigates” podcast in which one of our clients participated. Interestingly, the BBC’s investigation raised concerns for the first time that the manufacturer, Zimmer-Biomet, were aware that the implant had an increased rate of failure in comparison to the performance of similar implants, around eight years before it was officially withdrawn from market use in December 2022.

Zimmer-Biomet has been in the business of designing, manufacturing and selling various prostheses for decades. The first NexGen Complete Knee System was introduced in 1995 and has been subject to various design changes, modifications and developments since.

In 2012, Zimmer-Biomet began marketing a modified version of the NexGen knee. This was different to previous, well-regarded versions of the knee in that the tibial tray lacked a layer of plastic coating that had been used in previous versions of the component. This model was also cheaper than its predecessors, making it a popular choice for use in both NHS and private practice. Since then, thousands of patients have been fitted with this version of the implant.

The BBC’s investigation discovered that concerns around the longevity of the implant were first raised in 2014 by the National Joint Registry (NJR). The NJR is a system that records all types of prostheses implanted into patients, including knees, and provides valuable information into their performance and longevity. Their response to the first concerns raised was that there was insufficient data to draw any reliable conclusions as to the performance of the implant at that point in time, and so nothing further was done.

The investigation then revealed that further concerns were raised in Ireland around two years later in 2016, when an orthopaedic surgeon found that the rate at which he was performing corrective revision surgeries had significantly increased since he had begun using the NexGen knee implants in 2012. The lifespan of a knee implant is dependent on a variety of factors, including a patient’s activity level, weight and the type of surgery performed, with total knee implants lasting longer than partial knee implants. That said, knee implants are generally expected to last for at least ten years but are frequently seen to last for much longer than this in practice, with some even lasting up to and beyond twenty years; yet just a couple of years after the introduction and use of this modified NexGen knee implant, early revisions were being performed.

The response given by Zimmer-Biomet in relation to these concerns was simply that there was not a widespread problem with this implant. However, surgeons continued to raise concerns about the performance of the implant, with some having their professional competence questioned as a result of their increased need to perform revision surgeries.

Patients who had received these implants continued to suffer. The “File on 4 Investigates” podcast interviewed two patients in receipt of these implants who described their symptoms as being agonisingly painful, with one patient becoming addicted to morphine and now awaiting a hip replacement as a result of her failed knee implant causing her body to be pushed out of alignment and her now walking with a limp.

It was not until 2022 when the National Joint Registry identified that patients were nearly twice as likely to need corrective surgery after receiving the NexGen implant in comparison to those patients who had received other, similar implants from different manufacturers. Zimmer-Biomet, seemingly prompted into action, voluntarily recalled the use of all unused implants from the UK market in late 2022.

The recall of the implant and what this means for patients

Not all NexGen knee components are part of the recall. The recall currently concerns the NexGen Stemmed Option Tibial Components when used in combination with either the Legacy Posterior Stabilised (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components. We can check whether you were implanted with the notified parts.

The issue with the NexGen knee has since been identified as its tendency to cause early tibial loosening in patients. This is where the tibial tray, which is the section of the component implanted into the shinbone, has come away from the bone itself, causing patients to suffer from pain and instability in their leg. The only way to successfully treat this loosening is to remove the defective knee implant and replace it with a totally new one, often much earlier than most patients would have had to have the knee revised, if at all.

The most common signs and symptoms of a loose knee replacement include, but are not limited to:

• Pain
• Swelling
• Difficulty walking
• Instability
• Redness and warmth
• Painful popping
• Reduced range of motion

It is important that patients who believe that they may have been fitted with the recalled components and are suffering from the signs of early tibial loosening consult their doctors and surgeons. Your doctor or surgeon will be able to examine you and advise you as to the cause of your symptoms, whether that is attributable to the early loosening of the component, and prepare a suitable treatment plan with you. They may also be able to assist you in identifying whether your knee prosthesis falls within the parameters of the recall notice.

How we can help

We are currently instructed by a number of claimants to pursue claims against the manufacturer of the prosthesis, Zimmer-Biomet, under the Consumer Protection Act 1987. Where the surgery was performed in a private hospital on a privately paying basis even with insurance, claims may also be pursued for breach of contract under the Supply of Goods and Services Act 1982 and the Sale of Goods Act 1979, or the Consumer Rights Act 2015, depending on when the knee was implanted.

Mark Harvey, Partner and Head of our Specialist Claims team, said:

“We know that all implants can fail early and may also wear out, but a recall by a manufacturer is rare and therefore a very serious occurrence and patients should be compensated for this especially to help them in future years for the impact of another early revision.

The law requires all products sold to be of satisfactory quality and fit for purpose. A recall is good evidence that they never were and, even if the surgeon or clinic selling these devices was unaware, this does not give them a defence.”

There are time limits involved in personal injury claims. There is a standard three-year limitation period in any negligence claim, which runs from the date that a person knew, or ought to have known, that they had become injured as a result of a defective product. For many, this will run from the date that they were diagnosed with aseptic tibial loosening, but it may also run from whenever you first experienced symptoms and attributed those to resulting from a problem with your knee implant.

In claims against the manufacturer, if you wish to take advantage of the Consumer Protection Act 1987 which should in theory provide strict liability for a defective product, then there is an additional time limit which expires ten years from the date that the product left the control of the manufacturer, which is usually when it leaves the factory to be sold. Medical prostheses will typically sit on the shelves in hospitals for many weeks or potentially months before they are implanted into a patient and so it is likely that this period will have started running some time before your knee prosthesis was actually implanted.

It is the expiration of the earlier of these two dates by which court proceedings must be issued to prevent a claim becoming statute barred. It is therefore important that, if you think you have been affected by this device, you seek appropriate medical and legal advice as soon as possible.

Our product liability lawyers

• Assist some of the 700,000 or so people who are injured each year and wish to seek compensation for their losses. We can also assist those who have been injured and who could claim but feel unable to do so themselves.
• Investigate each potential claim thoroughly and offer early and ongoing assessments as to the prospects of success in your claim and the likely level of compensation and other remedies that you may be entitled to.
• Help clients who have suffered relatively minor injuries and those who have had the misfortune to suffer catastrophic and life-changing injuries.
• Work to the highest service standards so that we conclude your case as quickly as possible with the right remedy.
• Work on Conditional Fee Agreements (“no win, no fee”) so that if we do not win your case, there is no bill for you to pay.
• Have offices across the United Kingdom in Cardiff, London, Manchester, Plymouth and Southampton.

Our team has many years’ experience in bringing successful claims involving harmful products. Our expert advice has helped us to be ranked first as a representative of claimants in these types of cases by Chambers and Partners and the Legal 500, the independent guide to law firms. We have recovered compensation for many victims of harmful products ranging from an ordinary household product to medical and pharmaceutical devices.

Most recently, the firm has:

• Successfully represented claimants who received defective hip and spinal prostheses.
• Recovered compensation for claimants where the medical compound PEEK was used in upper limb joint implants.

Our current claims for defective products include:

• DePuy ASR Hips
• Oculentis intraocular lenses
• PIP silicone breast implants
• NutriBullet blenders
• Exploding vape batteries
• Contaminated patient cleansing wet wipes