FDA Warns: STAR Ankle Device Prone to Break

FDA Issues Safety Alert for the STAR Ankle

On March 15, 2021, the Food and Drug Administration (FDA) issued a safety communication regarding the STAR Ankle. The STAR Ankle (Scandinavian Total Ankle Replacement) devices, the FDA warns, have a “higher than expected risk of the polyethylene (plastic) component of the device breaking (fracture), as early as three to four years after implantation.”

The FDA communication is directed to healthcare providers, patients, and caregivers, and warns that fracture of the STAR Ankle could lead to surgery to replace or repair the device.

What is the STAR Ankle?

The STAR Ankle, manufactured by Stryker, is a “non-cemented” prosthetic ankle joint used to replace the painful joint in patients with osteoarthritis, rheumatoid arthritis, and post-traumatic arthritis. It was one of the first flexible ankle implants designed for this purpose.

It consists of several parts:

• A tibial plate
• A mobile-bearing polyethylene component
• A talar component

The STAR Ankle is designed to allow the patient to experience some normal mobility and function. It is the plastic, mobile-bearing component that is the basis for the FDA warning.

STAR Ankle Plastic Breaks More Than Anticipated

Since 2009, the FDA has received approximately 2,000 adverse reports about the STAR Ankle fracturing.

Since then, the FDA has expressed concerns about the long-term durability and strength of the plastic component of the STAR Ankle. The concern led to Stryker making some changes to the pre-implementation packaging of the component, which was supposed to help protect the plastic from unnecessary degradation.

This packaging change was made in 2014. About 300 of the 2,000 adverse event complaints were about STAR Ankle devices produced after the packaging change.

The FDA has now determined that the plastic component of the STAR Ankle fractures far more than expected – regardless of the packaging. One study indicates that the fracture rate is nearly 14% over eight years. Some fractured within as soon as 3-4 years after implantation.

The fracturing of the plastic joint in the STAR Ankle leads to pain and, for many, the need for additional surgery.

Why Does the STAR Ankle Break?

According to the FDA, there are several factors affecting the higher than expected breakage rate of the STAR Ankle. They include:

Device Design – the thickness of the STAR Ankle’s plastic component is a factor in the likelihood of breakage. Devices with a smaller thickness (6mm) are most likely to fracture compared with those that are 7-9mm. Only one fracture was reported in the STAR Ankle with the thickest plastic component (11-14mm).

Patient Factors – STAR Ankle implants in patients with higher levels of activity and those under 55 are more likely to fracture than others.

Material – the plastic used in STAR Ankle’s mobile bearing component degrades, increasing the likelihood of fracture.

The FDA wants doctors to share these risks with patients, help them understand what they imply, and together arrive at an informed decision about whether to proceed with the implantation of a STAR Ankle device.

What Should You Do If You Already Have a STAR Ankle Implant?

The FDA is not recommending the removal of the STAR Ankle device at this time. They insist that it remains an appropriate solution for many patients including those who are older with less active lifestyles.

Instead, the FDA suggests the following if you have a STAR Ankle implant:

• Talk to your doctor if you experience new or worsening instability, grinding or other noises, pain, or inability to bear your weight
• You might have to undergo tests such as X-rays or CT scans so your doctor can evaluate the integrity of your STAR Ankle
• Contact the FDA if you suspect there is a problem with your STAR Ankle device

What Happens Now? Will the FDA Recall the STAR Ankle?

The FDA has not recalled the STAR Ankle device. The agency wants the public and health care providers to understand the risks and dangers of the STAR Ankle. In the agency’s own words, They “will continue to work with Stryker to ensure that patients and providers are aware of the potential risk of plastic component fracture, to identify any potential mitigation measures, and to ensure that the product labeling addresses the concern.”

Call our Dangerous Medical Device Lawyers

Call Alonso Krangle, LLP, if you have been injured by a dangerous medical device.
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Source:

• https://www.fda.gov/medical-devices/safety-communications/risk-device-component-breaking-patients-strykers-star-ankle-fda-safety-communication
• https://www.fiercebiotech.com/medtech/fda-issues-safety-alert-for-plastic-breaks-stryker-made-star-ankle-replacements