According to the Medicines and Healthcare Products Regulatory Agency (“MHRA”) and the British Orthopaedic Foot & Ankle Society (“BOFAS”), patients who have received a total ankle replacement with the Ankle Evolution System are more likely to develop osteolytic lesions. The system has since been recalled.
Osteolytic lesions are a consequence of osteolysis—an adverse reaction to foreign material. Once osteolysis develops, a patient’s bones become soft and gradually disintegrate. Not surprisingly, this process causes joint failure and generalized bone destruction in the area. In cases of ankle replacement, severe osteolysis may require amputation of the lower leg. Unfortunately, osteolysis often begins without appreciable symptoms and a diagnosis is only made through x-rays.
The Ankle Evolution System was manufactured by Transysteme SA and marketed by Biomet. According to the MHRA, Transysteme has recalled all lots of the device. The agency is recommending that U.K. doctors identify all patients with the system and follow up with their care. Additionally, CT scans are recommended if patients are experiencing increased pain or x-rays demonstrate the presence of lesions. Surgical intervention is an option once lesions are confirmed.