Stryker’s STAR

In October 2019 Stryker, one of the world’s leading medical technology companies, has issued an urgent field safety notice in relation to its STAR (Scandinavian Total Ankle Replacement).

Total Ankle Replacements (TAR’s) gained in popularity in the 1970’s and are now going through an evolution. A new wave of TARs are replacing ankle fusions (arthrodesis) which have historically been the main surgical treatment for ankle osteoarthritis.

TAR’s are generally performed on patients with post traumatic osteoarthritis. They are not as widely used as hip and total knee replacements (TKR’s). Of the 29,000 patients who present with osteoarthritis in the UK, approximately 3000 will undergo surgery through the NHS. It has however been reported that the number of fusion surgeries remains static but that the number of TAR’s has been increasing.

Stryker’s STAR system is considered a second-generation design first developed in 1978. It originally consisted of two components but through modifications has now become a three-component design with the addition of the polyethylene spacer. Over the thirty years that it has been on the market approximately 30,000 STAR systems have been sold.

Manufacturers are now on to the third and fourth generation devices. The STAR makes use of an ultra-high molecular weight polyethylene (UHMWPE). This is a three-component system, making use of the polyethylene spacer.

Stryker has become aware of data from patients implanted with the STAR device, distributed prior to 1 August 2014 that there is a higher-than-expected risk of polyethylene fracture. If you were implanted with a Stryker STAR prior to 1 August 2014, it is worth speaking to a solicitor who specialises in joint replacements to find out your legal rights.

The safety communication can be viewed here.

Stryker is warning that the potential risks associated with the polyethylene mobile bearing fracture include:

• Significant pain, whether this pain is a new development, or it has been experienced for a significant time
• An inflammatory response, whether this inflammation is a new development, or it has been experienced for a significant time
• Soft tissue injury e.g. blistering
• Loss of mobility in the operated ankle
• Possible damage to the metal component of the ankle after the polyethylene fractures requiring revision of the entire TAR

It has also given the additional warning that the fracture of the polyethylene part of the TAR can be subtle. There does not necessarily have to be a significant injury to have a polyethylene part of the ankle fail. Symptoms indicating that a complication has occurred are:

• Increased pain
• Inability to bear weight
• New onset of a grinding sound or other noise
• Worsening instability in the ankle

In the event that a patient experiences any of the above symptoms, they are advised to contact their GP/surgeon.

How can we help?

If you have had a Stryker total ankle replacement and believe you have developed symptoms of pain, loss of function or instability as a result, you may be able to make a claim against the manufacturer.

Get in touch with our harmful products team using the envelope or telephone buttons on this page to find out if you are eligible to claim.

Do I need to get my joint prosthesis replaced?

The answer to this question depends on the severity of your symptoms and the extent of the damage being caused by the replacement joint.

Typical symptoms of joint implant failure include:

• Pain or aching in the joint and surrounding area
• Reduced mobility
• Difficulty sleeping

If you experience any of these symptoms, then your first course of action should be to contact your doctor for advice. Be sure to ask them what make and model of joint prosthesis you have.

Your next course of action should be to contact our Harmful Products team to see if you have a claim.

Some patients who have defective joint implants may not experience any physical symptoms of failure. Abnormal blood test results and x-rays can also be signs of a defective implant.

Am I eligible to make a claim?

Replacement joints do not typically last as long as natural joints do. Because of this, not all joint implants are eligible to claim. If a particular type of replacement joint experiences higher than expected rates of failure, then patients may be able to claim.

The best way to be sure is by having a conversation with a specialist solicitor who will know which implants and what scenarios qualify to claim. The Harmful Products team at Hugh James is always just an email or a phone call away.

How long do I have to make a claim?

Claims for defective products must be brought within 10 years of the date that the product left the control of the manufacturer and was put into circulation. This is usually shortly after the date of manufacture. Claims must also be brought within 3 years of the patient gaining knowledge that their hip has failed.

How do I know what kind of implant I have?

If you received an implant that there is a known problem with then you are probably already being monitored regularly by your doctor to track the extent of the damage being caused by your defective implant. Regular blood tests can detect abnormal levels of metal in the blood which will indicate if the implants are causing an adverse reaction. If you have had a joint replacement but are worried or unsure which type you have had implanted, you should contact your doctor for advice.

When components are implanted into a patient a product label will be documented in a patient’s hospital records. The component labels will record the identity of the manufacturer and all batch and reference numbers. This information is also entered on a central register at the National Joint Registry (NJR). Patients can obtain the information from the hospital they received treatment from or the NJR.