23 July 2012
The Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert
for the Ankle Evolutive System (AES) total ankle replacements manufactured by Transysteme on Wednesday 18th July. The alert follows a review of scientific literature by the British Orthopaedic Foot & Ankle Society (BOFAS), which indicated that the device “displays a higher than expected frequency of osteolytic lesions.”
The Ankle Evolutive System total ankle replacement system is manufactured by Transysteme, a French company. The MHRA alert, relates to all lots of the device.
Ostyeolytic lesions are usually associated with the condition osteolysis. Osteolysis is the degeneration of bone tissue, and can be caused by infection, ischaemia or disease. Whilst the symptoms of osteolysis are often asymptomatic, the consequences of the condition remaining undetected can be failure of the joint and destruction of the bones around the ankle, with extreme cases resulting in lower leg amputation.
The MHRA alert states that reasons for the osteolytic lesions with the Transysteme AES are currently unknown.
Transysteme has informed the MHRA that approximately 450 of these devices were implanted in the UK from 2002 to 2009 inclusive, and is recommending that doctors in the UK identify patients with the AES device. Patients implanted with the device should be followed up annually, and doctors should consider:
- CT scan if patients present with increasing pain or if X-rays show evidence of lesions
- More frequent follow up for patients presenting with minor asymptomatic lesions
- Surgical intervention for symptomatic or larger/multiple lesions
If you have developed any health problems such as increased pain following the fitting of an AES total ankle replacement device, and think that you may have a claim for compensation, please contact our nationally recognised medical devices team by calling specialist product liability partner Jill Paterson
on 020 7650 1219
for a free and confidential initial discussion.
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