Ankle Replacement Lawsuit

Ankle replacement surgery replaces damaged bone and cartilage in the ankle joint with an artificial joint to ultimately alleviate a patient’s pain and preserve the motion of the joint.

Typical reasons a patient may require an ankle replacement surgery include; arthritis (rheumatoid arthritis, osteoarthritis, and arthritis caused by injury), bone fracture, infection, osteonecrosis/avascular necrosis (AVN), and tumors.

In an ankle replacement surgery, your surgeon starts by making a surgical cut in the front of your ankle to expose the damaged joint. Then your surgeon will move tendons, nerves, and blood vessels to the side and excise the damaged bone and cartilage. Your surgeon will also remove any damaged areas of your tibia (shin bone) and talus (foot bone).

Once all of the damaged bone and cartilage has been removed, your surgeon will attach the artificial joint to your bone. A special glue or bone cement will be used to hold the joint in place. Screws may also be used to stabilize your joint.

An artificial ankle joint consists of three parts: a metal plate that is attached to the tibia, a metal plate that is attached to the talus, and a segment of polyethylene (plastic) that is placed between the two metal plates.

After your surgeon has implanted the artificial joint, they will reset your tendons, nerves, and blood vessels, then complete the procedure by stitching the wound closed. You will likely need to wear a cast or brace for a period of time after your surgery to prevent excess movement. Your surgeon will also instruct you to keep weight off of your leg until your implant has completely healed.

As with any other surgery, ankle replacement surgery comes with risks such as allergic reactions to medications, bleeding, blood clots, breathing problems, and infection.

Specific risks of ankle surgery also include:

• Allergic reaction to the implant
• Ankle instability, stiffness, or weakness
• Blood vessel or nerve damage
• Broken bones during surgery
• Dislocation of implant
• Loosening of implant over time
• Skin that does not heal after surgery

There can also be surgical complications due to your lifestyle and the medications and supplements that you take. Always be sure to discuss your medical history, current conditions, and any drugs or supplements that you take with your healthcare provider prior to surgery.

On March 15, 2021, the U.S. Food and Drug Administration announced a higher than expected risk of the polyethylene (plastic) component of Stryker’s STAR Ankle device fracturing. Fracture of this component could lead to surgery to replace or repair the device. Stryker sold its STAR ankle to Colfax, a division of DJO Global in November 2020, as part of its move to acquire Wright Medical. The FDA noted that the risk of fracture applied to all STAR ankle devices, regardless of the manufacture or distribution date.

On February 7, 2022, Exactech recalled its Exactech total ankle system due to concerns that its polyethylene liner leads to excessive wear, bone loss, and device failure requiring revision surgery.

Medical device manufacturers have a duty to supply surgeons with safe medical devices for the health and wellbeing of their patients. Many patients who received these defective ankle implants have suffered severe health consequences. Lawsuits are currently being filed against these negligent companies, claiming that corporations could and should have prevented these defective devices from being used or provided patients with clear warnings about potential health risks.