Ankle Evolution Systems: Replacement

Ankle Evolution Systems Total Ankle Replacement Lawyers

Ankle Evolution Systems, Ankle Replacement Lawyers. Have you suffered complications, including osteolysis or the development of osteolytic lesions, following ankle replacement surgery involving the Ankle Evolution System manufactured by Transystème’s and marketed by Biomet? A recall was issued in the U.K. in July 2012 for all lots of Ankle Evolution System total ankle replacement […]

Ankle Evolution Systems Total Ankle Replacement Complications

The Ankle Evolution System is a modular system used in total ankle replacement that features a cobalt-chromium cementless prosthesis. By 2009, the joint system was associated with a very high rate of osteolysis, with the complication occurring in more than 50% of patients, according to some studies.

Osteolysis associated with the device is believed to be the result of the body’s reaction to small particles of metal shed from its components. Osteolysis causes damage to healthy bone, which will become soft and disintegrate over time.

In the most extreme cases, osteolysis associated with the Ankle Evolution System has required amputation of the lower leg. In July 2012, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued an alert to warn that the Ankle Evolution System had been recalled.

According to the warning, a high number of patients implanted with the Ankle Evolution System had developed osteolytic lesions, a consequence of osteolysis. The MHRA has advised doctors in the U.K. to identify all patients who received the Ankle Evolution System in total ankle replacement procedures.

According to the agency, these patients should be monitored annually for osteolytic lesions. CT scans are recommended for patients experiencing pain, or in cases where x-rays indicate the formation of lesions.

Those who present with minor, asymptomatic legions should undergo more frequent follow-up. Patients with symptoms or larger lesions may require surgical intervention.

Need Legal Help Regarding Ankle Evolution Systems?

If you or someone you love suffered from osteolysis or developed osteolytic lesions following total ankle replacement with the Ankle Evolution System, you may have valuable legal rights. To discuss your case with an experienced medical device lawyer at Parker Waichman LLP, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) today.

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