What is the STAR Ankle Replacement?
The STAR Ankle is a non-cemented total artificial joint used to replace ankles suffering from osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis. The device is made of a tibial plate, a mobile-bearing polyethylene component, and a talar component.
What’s the Problem?
According to an FDA Warning Letter dated 3/15/21, a long-term post-approval study found that STAR Ankle Replacements fractured at a rate of 13.8% (12/87) at 8 year post-implantation, with some fractures occurring as early as 3 to 4 years after implantation. FDA also reviewed data provided by Stryker on 244 STAR Ankle replacements that were removed, which found at least 72 plastic component fractures. All fractures required additional surgery, the agency said.
FDA attributes STAR Ankle Replacement fractures to a variety of factors, including:
- Device design (component thickness)
- Material (degradation)
- Surgical factors
- Patient factors (i.e. younger patients with higher activity levels)
The risk of fracture has been previously acknowledged by Stryker; however, the company’s prior communication excluded implants that were manufactured after August 1, 2014, when changes were made in the inner-pouch foil packaging to limit the material degradation of the polyethylene component.
“Based on the FDA’s recent analysis of FDA-required post approval studies and adverse event reports, the potential risk of the plastic component breaking may exist for all STAR Ankle devices, regardless of the date of manufacture or distribution,” the agency said.
Symptoms of Ankle Replacement Fracture
- New worsening pain
- Inability to bear weight
- New grinding or other noise
- Instability in the implant
Who’s at Risk?
Patients at the greatest risk of ankle replacement complications include individuals with more active lifestyles, osteoarthritis (disease where the protective joint tissue breaks down and causes pain and swelling), or age younger than 55 years old. FDA has provided the following recommendations to help patients monitor for signs of potential STAR Ankle fracture:
- If you are considering a STAR Ankle, discuss all available treatment options for painful arthritic ankle joints with your healthcare provider.
- If you have a STAR Ankle Replacement, consult your healthcare provider if you experience any new worsening pain, inability to bear weight, new grinding or other noise, or instability in your implant.
- Be aware that your healthcare provider may perform an examination of your STAR ankle and obtain X-rays to evaluate the device. In some cases, a computed tomography (CT) scan may be necessary to assess if the plastic component in your ankle is broken.
Do I Have a STAR Ankle Replacement Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in STAR Ankle Replacement Lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.
If you or a loved one was injured by an ankle replacement device, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.