A knee-replacement implant, used in thousands of UK operations, was known to have a concerning failure rate eight years before it was finally withdrawn, the BBC has discovered.
NexGen Knee Implant Failures Lead to Patient Suffering and Legal Battles
In a recent investigation, patients who received the NexGen knee implant have shared accounts of becoming immobile or addicted to painkillers after the device slipped out of place. This has led to hundreds of individuals needing a second, corrective surgery.
Knee surgeons allege that the implant’s manufacturer, Zimmer Biomet, was slow to admit there was an issue with a specific component.
In response, Zimmer Biomet stated that patient safety is its “top priority” and that all its products are approved according to relevant regulations.
The Ripple Effect of a Failed Knee Replacement
After undergoing a knee replacement in 2016, Debbie Booker from Southampton initially believed the operation was a success.
However, a year later, while on holiday, she began to experience excruciating pain. “I laid a bag of ice on my knee and for four days I had to do that every few hours because I was in agony,” she recounted.
According to Booker, the pain stemmed from the implant slipping from her tibia and wearing away the bone. The ordeal led to a dependence on prescription painkillers.
“I was on fentanyl and morphine. It took me a long time to come off of the morphine because I was addicted.”
Booker has since had a second knee replacement, but the failure of the initial implant has resulted in lasting health complications.
“It’s put my whole body out of alignment, I walk with a limp,” she explained, adding that she is now awaiting a hip replacement due to the ripple effect of the failed surgery.
Patients Allege Flawed Tibial Component Caused Severe Complications
Another patient, identified as “Diana” to protect her anonymity due to her former employment with the NHS, had a similar experience.
Her knee implant, fitted in 2021, also slipped and began to erode her shin bone, leaving her unable to walk.
“The consultant told me every time I stood up; I was standing on a broken leg. It was absolute agony,” she shared.
Identifying the Defective Component: A Missing Plastic Layer
Both Debbie and Diana received a specific component during their knee replacements: a “stemmed option tibial component,” also known as a “tibial tray.”
This particular component, unlike earlier, successful versions of the NexGen knee, lacked a crucial plastic layer.
Widespread Use of a Modified Implant Despite Early Concerns
At the beginning of 2012, Zimmer Biomet introduced a modified, more affordable version of its knee implant to the market.
According to Professor David Barrett, a knee specialist at Southampton University, the new version’s lower cost made it a financially attractive option for the NHS. “[‘The NHS] were justified by saying, ‘we have every reason to think it’ll be fine,'” he noted.
In the ten years that followed, this version of the implant was used in over 10,000 patients.
Despite its widespread use, the modified implant raised early concerns.
An investigation by “File on 4” found that the National Joint Registry (NJR), which tracks implant surgeries in England, Wales, and Northern Ireland, first flagged issues in 2014.
The NJR stated that at the time, there was not enough data to draw firm conclusions and that identifying a single faulty component is a complex process.
An Irish Surgeon’s Warning Goes Unheeded
Concerns about the implant resurfaced in 2016, this time in Ireland, where Professor Eric Masterson, a knee surgeon in Limerick, raised the alarm.
After starting to use the NexGen implants in 2012, his rate of corrective surgeries skyrocketed, leading to his professional competence being questioned.
“That was a lonely place,” he told “File on 4 Investigates.” “You spend a lifetime building up a career and a reputation, and it’s very easy to have that career shredded.”
Professor Masterson says that when he brought his concerns to Zimmer Biomet representatives, they assured him the problem was not widespread. This account was echoed by several NHS surgeons who reported similar experiences.
Internal Documents Suggest Company Ignored Early Warnings and Limited Communication
Professor Masterson requested that surgeons in the UK be contacted so that their records may be compared.
However, according to private internal company documents obtained by File on 4 Investigates, the business would only contact surgeons on his behalf if they were regarded as “friends of Zimmer Biomet” and “happy with their NexGen patients”, according to the documents.
Professor. Leila Biant, one of the top knee surgeons in the UK, claims that Zimmer Biomet did not take prompt action after the issue was discovered. She claims that as early as 2017, she and other colleagues had concerns.
“The issue is [the company’s] initial reluctance to acknowledge a problem and to not engage with a process to evaluate these patients until [Zimmer Biomet] got to a situation where they had to,” she informs us.
Recalls, Rising Costs, and Unanswered Questions
In 2022, the National Joint Registry (NJR) concluded that patients with the NexGen implant were twice as likely to require corrective surgery compared to those with the average knee implant.
The same year, Zimmer Biomet recalled all unused implants from the UK market.
Peer-reviewed studies have estimated the failure rate for the specific tibial tray component of the NexGen implant to be between 6% (twice the expected rate) and 19%.
In a statement to the BBC, Zimmer Biomet said, “When new data becomes available, we act appropriately, responsibly, and by applicable regulatory requirements.”
All 10,000 patients who received the problematic implant should now have been called back for a review. Hundreds have already undergone a second operation, with more likely to follow.
The cost to the NHS for each corrective surgery is significant, ranging from £10,000 to £30,000. Professor David Barrett from Southampton University estimates the total cost could run into millions of pounds.
When asked by “File on 4 Investigates” if it would contribute to the costs, Zimmer Biomet did not respond.
However, a confidential company email from 2022 instructed sales staff to state that “Zimmer Biomet will not cover diagnostic, follow-up or revision costs up front.” NHS England has confirmed it is “currently reviewing the case.”
Frequently asked questions
What could be deemed negligent in surgical operations?
Your surgery and care should meet certain clinical standards; however, any surgical operation represents an element of risk. Even the most routine procedures involve a patient entrusting their life to a team of doctors. When a surgical procedure goes wrong due to an avoidable surgical error, the effects can have a life-altering impact, both physically and psychologically, on the patient.
Surgical negligence happens when surgeons or other medical professionals make mistakes during your operation, leaving you with avoidable problems or injuries. This can include:
- Performing the wrong operation/operating on the wrong body part
- Leaving foreign objects in the body
- Failing to inform you about the possible risks of surgery or to check your suitability for surgery.
- Injecting too much or too little anaesthesia
- Causing avoidable nerve damage or injury to your organs.
- Negligent surgical treatment can severely affect a patient’s life, recovery period, and in more serious cases, result in death.
If you have received negligent surgical treatment which has left you in a debilitating condition or unnecessary pain and suffering, you may be eligible to make a clinical negligence claim.
Who can bring about a claim?
The victim of the negligence can bring about a claim in their own right. However, it is often sadly the case that the victim is either unable to bring about a claim or has sadly passed.
In such circumstances, a claim can be brought about on their behalf either by an appropriate person or litigation friend if the victim is still with us or by the executor of the estate of a surviving dependant if the victim has passed.
Our specialist team will be able to discuss whether you have a right to bring about a claim, so if you or a loved one has been affected, do not hesitate to contact us.
How long do I have to claim?
Claims of this nature are subject to a three-year limitation period. This means that claims have to be commenced within the Courts in three years of the date the negligent act occurred or the date you became aware that negligence had occurred. In cases involving deceased victims, this limitation period commences from the date of death and in cases involving minors, the limitation period starts when they reach their 18th birthday.
The law surrounding limitation periods is complex; our specialist team will be able to advise further.
How much is my claim worth?
It is often difficult to value clinical negligence claims at their outset, given the complexities involved; however, we will pursue two forms of compensation for you:
- General damages – an award of money for the pain and suffering you have endured as a result of the negligence.
- Special damages – an award of money for all of your out-of-pocket expenses, such as travel expenses, medication costs, loss of earnings, and treatment costs, both past and future. This list is not exhaustive and is very case-specific.
Further Information:
The knee implant used by the NHS has been known for years to be faulty.
Oakwood Solicitors: Negligent Surgical Operations and Medical Care.
WHAT TO DO NEXT
We have a dedicated team of solicitors and paralegals who have many years’ experiences between them in running cases of this nature. They are highly trained to deal with all aspects of clinical negligence.
Get in touch today for a no-obligation consultation. Choose one of the methods on the right-hand side of this page or call us on 0113 360 2124 to find out how we can help you.
Carol Cook joined Oakwood Solicitors in May 2017 to lead the Medical Negligence Department.
Carol handles a wide range of clinical, cosmetic and dental negligence claims and has years of experi…
Negligent surgical procedures – Client case studies
Here are two recent medical Negligence client case studies regarding negligent surgical procedures, complete with their awarded compensation amounts and a client testimonial.
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