Pryers Solicitors have been instructed to investigate a potential product liability claim concerning the Biomet Ankle Evolution System (“AES”) ankle replacement components.

The AES was designed and manufactured by a French company called Transysteme SA, but imported to the UK and marketed under the Biomet name. The joint consists of two metal components, made of a cobalt/chromium alloy, with a polyethylene floating bearing sandwiched between them.

In 2004, the Leeds Teaching Hospitals NHS Trust received funding from Biomet to become a “centre of excellence” in the use of the AES ankle and many patients in the Yorkshire area were fitted with the joint.

Initial results were thought to be encouraging, but by 2009, reports were emerging that the joint was associated with a very high rate of osteolysis. This occurs when the body detects tiny particles of foreign material and reacts against them, also causing damage to healthy bone. The bone becomes soft and gradually disintegrates.

Some studies have reported osteolysis occurring in more than 50% of patients with this particular product. In some cases, the osteolysis can be seen on x-ray but causes the patient no symptoms. In other cases, it can lead to failure of the joint and destruction of the bones around the ankle. In the most extreme cases, it has required amputation of the lower leg.

The AES joint was withdrawn from the market in the UK, but was not subjected to any formal action by the medical product authorities. However, it continued to be sold in France, under the Transysteme name, until being formally recalled by the authorities in January 2011.

Pryers are now working with some of the world’s leading experts in ankle surgery to determine whether the AES is defective and whether the problems encountered could and should have been identified before the product came onto the market.

If you have suffered problems with a Biomet AES ankle replacement, please contact Richard Starkie on 01904 556600 or by email at richard.starkie@pryers-solicitors.co.uk.