FDA Issues Warning About the Risk of STAR Ankle Component Breaking in Patients

Searcy Denney Scarola Barnhart & Shipley
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Searcy Denney Scarola Barnhart & Shipley

This past March 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication that provides information and recommendations for patients who have or are considering a STAR (Scandinavian Total Ankle Replacement) ankle replacement, previously manufactured by Stryker. The plastic ankle replacement carries a higher than expected risk that the device’s plastic (polyethylene) component will break as early as three to four years after implantation. Fracture of the plastic piece of the STAR Ankle may lead to surgery to replace or repair the device.

The devices are designed to repair ankle joints that have become damaged and, accordingly, cause consistent pain, commonly due to the onset of osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. Replacing the ankle joint allows greater ankle motion. The procedure is meant to allow increased mobility and to offer an alternative for patients living with pain or taking medications to provide joint pain relief.

FDA Advice

According to the FDA safety communication, the FDA is not recommending the removal of implanted STAR Ankles. Even though the risk of fracture is higher than expected, The FDA claims that the device remains appropriate for some patients, such as low-activity, older patients. Those who have had STAR Ankle replacement surgery should meet with their surgeon, follow their advice and recommendations, schedule follow-up visits, and let their surgeon know if their pain increases or the STAR Ankle becomes unstable.

What Are My Legal Options?

Manufacturers have a legal responsibility to produce reasonably safe products. Defective medical devices, such as the STAR Ankle, can give rise to a product liability claim if a person using a defective medical device is injured or dies due to the defect or even needs replacement surgery.

Although defective product laws vary from state to state, products liability law usually requires that you prove:

  • The product is defective
  • You were using the product as intended
  • You were injured or suffered losses
  • The defect caused your injury 
  • The injury caused damages

Let a Florida Product Liability Attorney Help You With Your Defective STAR Ankle

The STAR Ankle is the latest in a long history of defective replacement devices. A Florida product liability attorney has experience with these types of situations and knows the product liability laws in Florida.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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