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The MHRA (Medicines and Healthcare products Regulatory Authority) issued a medical device alert on 18 July 2012 in relation to a total ankle replacement implant. The Ankle Evolutive System, manufactured by Transysteme, has been linked with a higher than expected frequency of osteolytic lesions in patients implanted with the total ankle replacement implants.
The osteolytic lesions usually form as a result of osteolysis. This is where particles rub off the implant and the body tries to clean these up, it triggers an auto-immune reaction which causes living bone to be absorbed. It can be seen on X-rays and appears as though there are holes in the bone or “punched out” areas.
The reasons why the lesions form are currently unknown and the manufacturer has stopped further distribution until further information becomes available.
The MHRA have been informed that from 2002 to 2009 there were approximately 450 of these devices implanted within the UK. The MHRA are advising that people who have received these implants should be monitored at least every year. People will be monitored through CT scans if they are experiencing increased pain and this could lead to surgical intervention if there are large or multiple lesions.
If you, or a member of your family, have suffered pain or disability as a result of being fitted with a Transysteme Ankle Evolutive System, our expert defective products team could help you to claim compensation.
We’re well known for our understanding of compensation claims for people injured by defective or faulty products and we will fight fearlessly to achieve the best outcome for your claim. We know what positive action to take to help you and our expert team can offer the dedication and sensitivity you need. Above all, we will put you first.
If you were fitted with an Ankle Evolutive System and have suffered pain or disability as a result, you will want to know that your legal advisors have the experience needed to help you with your claim.
Over the years we have helped many people to claim compensation for suffering caused by faulty medical products and drugs. We have a great deal of experience dealing with claims involving orthopaedic devices, including the De Puy ASR and other metal on metal hip replacements.
In 2011, Chambers & Partners ranked us in the top band of law firms in the UK for claims relating to defective products. Clients reported that our lawyers "respond quickly to clients' needs and have a no-nonsense approach - they know what they are talking about and get on with it".
This experience means we know what needs to be done to bring the manufacturer to task and help you to achieve the best possible compensation settlement.
If you would like to discuss this issue further please contact a member of our specialist team on 0370 1500 100 or complete our online enquiry form and a member of the team will contact you.
Our expert medical negligence lawyers will provide you with free initial advice on your compensation claim if you have been injured or fallen ill as a result of faulty or defective medical products or medicines. See our Defective Medical Products Drugs Or Medicines Claims page for more information.