DePuy Synthes Radial Head Elbow Prosthesis System

The implant is manufactured by Synthes GmbH, a subsidiary of Johnson and Johnson. The company issued an Urgent Medical Device Field Safety Notification stating that if the radial stem becomes loose post-operatively, the following may occur:

• device loosening
• osteolysis (loss of bone) and bone fracture
• poor joint mechanics
• pain
• soft tissue damage (soft tissue irritation)

The company has removed the DePuy Synthes Radial Head Prosthesis Stem from the global market.

Surgeons have been advised to stop implanting the device immediately and to identify and advise that if you have been implanted with an affected device then you should contact your surgeon if you develop symptoms such as pain, loss of function or instability.

After contacting your surgeon, you should contact the Harmful Products team at Hugh James to find out if you are eligible to make a claim.

In addition, they have advised that you should be monitored at 6 monthly intervals for up to 2 years post-implantation, with both clinical and radiographic assessments to identify possible loosening of the radial stem.

Even if you haven’t been identified with loosening of your implant, you should continue to be monitored at six-monthly intervals for progressive osteolysis (including the potential risk of fracture), or the development of symptoms needing surgery to replace the implant.

In 2015, 655 elbow replacement procedures were performed in the UK according to the National Joint Registry an increase of just over 12% on the previous year.

If you have had a DePuy Synthes Radial Head Prosthesis System implanted at any point since 2015 when they were introduced in the UK and you have required or still require follow up surgery to address issues with the implant, you may be eligible to make a claim against the manufacturer and should get in touch to find out more.

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.