Specialist Lawyers Representing Group Of Patients See Growing Evidence Of Implants Built From Different Components

Lawyers representing people suffering severe health problems as a result of faulty hip implants have warned that they are increasingly being asked for help by patients fitted with unregulated, ‘mix-match’ devices built from components produced by different manufacturers.

Irwin Mitchell’s specialist Product Liability team has launched legal action on behalf of a number of victims who have endured serious complications with hip replacement devices, only to discover that they have been fitted with products manufactured by different companies.

This is significant as the majority of orthopaedic device manufacturers specifically state that their products must not be used in combination with products from other manufacturers. Hip replacement devices are made up from several components, including in most cases a femoral stem, acetabular component (or socket) and femoral head (or ball).

Such ‘mix-match’ products are new devices that do not have Regulatory approval for their use in patients and have no pre-existing testing to ensure that the devices will perform or last as they are expected to.

The team is warning that the creation of such devices renders the CE mark – the sign of regulatory approval – on the original components redundant, meaning patients fitted with such ‘mix-match’ products are being put at an increased risk of serious health problems. There is also a question mark over the consent given by the patients to the implantation procedures carried out

Problems with metal-on-metal hips made by manufacturers such as DePuy, Zimmer, Corin, Finsbury, Smith & Nephew and Wright Medical Technology, have been known about for years. Irwin Mitchell are the first lawyers to tackle the issue of healthcare providers using components produced by different manufacturers in breach of the European Regulatory regime.

After issuing letters of claim to several private and NHS hospitals on behalf of their clients, the expert lawyers have now called on the organisations to work with them to further investigate where this practice is happening, improve education for medical professionals in relation to this issue and improve patient care for the future. 

Expert Opinion

Many of our clients affected by mix-and-match metal-on-metal hip implants came to us purely due to concerns regarding injuries and complications they have suffered with the devices.

"It is only after reviewing their medical records that it has been revealed they have been fitted with devices essentially manufactured by healthcare providers prior to surgery, using parts from different manufacturers. This is not how these devices were intended to be used.

"With the NHS performing more than 66,000 hip procedures in England and Wales in 2013, we are concerned by the seriousness and potential extent of this issue. When the individual components are given regulatory approval by authorities it is with the intention that they are used with comparable products from the same manufacturer or approved by the manufacturer and they are not built to be used with other products. Rebuilding mix-matched products makes this approval void, as it means the creation of what is legally an entirely new device.

"From what we have seen, it also means that patients who have been fitted with such devices without their knowledge often need earlier revision, due to faster deterioration of components which have been used together despite not being built for that purpose

"We are hopeful that the NHS and the private healthcare industry will work with us to investigate the problems our clients have faced, while we feel it is also vital for manufacturers to further stress to medical professionals the importance of ensuring their devices are maintained and used in the manner intended." Kevin Timms - Solicitor

Among those being representing by Irwin Mitchell in relation to this issue is Keith Humphris, 56, from Cheltenham, Gloucestershire. After being diagnosed with osteoarthritis in both of his hips, he was reviewed by Cheltenham Hospital and subsequently fitted with metal-on-metal hip implants in 2008.

Keith Humphris recalls: “I was told that I would be given a metal-on-metal hip implant which was described as the best type of implant for some who was my age and active. My rehabilitation following the procedure went well so I was really looking forward to the future. However, in 2010, I began to suffer continued severe pain and weakness in both of my legs. After blood tests in 2011, it emerged that I had increased metal ion levels, while an MRI scan in 2012 revealed a collection of fluid around both of the implants.”

In 2013 – just five years after the original hip implants were fitted – Keith underwent revision hip replacements on both of his legs and while he continues to use walking sticks he has regained  some more mobility.

Looking back on his problems, he said: “When you are fitted with hip implants you just don’t expect that you will face the issues I have – you just expect everything to be OK.

“Due to my health problems, I had to give up the management of my farm shop and was unable to proceed with plans to launch a gardening and DIY business – all of my plans and hopes for the future have had to go out of the window.

“You also place great faith and trust in both those undertaking the procedure and the manufacturers of the device you are fitted. Because of this, it was a major shock to be told that I’d been fitted with something which essentially did not meet regulatory standards.

“This should simply not happen and I want answers as to how this was allowed to. While nothing can change what I’ve been through, I know that at least steps can be taken to ensure others who need hip implants do not face what I have in the future.”

Our experienced personal injury claims team will provide you with free initial advice on your compensation claim if you have suffered as the result of a faulty metal-on-metal hip implant. View our Metal-On-Metal Hip Replacement Claims page for more information.

Expert Opinion

Many patients won’t know whether their metal-on-metal hip implant is from a single manufacturer or a mix-match design. Many implants will be functioning fine and some patients may never suffer any problems, but if you are suffering from pain or discomfort in relation to a hip replacement, we recommend seeking medical advice as soon as possible.” Kevin Timms - Solicitor