What's the Problem?
The plastic component of the STAR Ankle fractured at a rate of 13.8% (12/87) at 8 year post-implantation, with all fractures requiring additional surgery, according to the results of a long-term post-approval study [1]. Since 2009, at least 1,841 adverse event reports have been linked to the STAR Ankle Replacement. FDA found that about 300 of these reports described fractured plastic components.
"Fractures were observed as early as three to four years after implantation, which was unexpected," FDA said. "This higher fracture rate and earlier than expected occurrence are concerning when compared with other comparable total ankle replacement devices, and may also be underestimated as two polyethylene fractures were not diagnosed until surgical exploration in this study."
Additionally, FDA reviewed data provided by Stryker on 244 STAR Ankle replacements that were removed, which found at least 72 plastic component fractures. Fractures were observed more frequently in thinner plastic device components (6mm thickness) as opposed to thicker components (7mm-9mm), with only 1 fracture observed in the 11-14mm thickness range. Most of the plastic component fractures showed material oxidation degradation after 3 to 4 years of implantation and exhibited loss of mechanical properties.
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.
"The FDA considers plastic component fractures in the STAR Ankle may be attributed to multiple factors, including device design (component thickness), material (degradation), surgical factors, and patient factors (such as younger patients with higher activity levels)," the agency said. "Therefore, while the long-term fracture rate is not known in devices manufactured after the 2014 packaging change, all patients who have the device implanted or are considering getting the device should be aware of the risk of plastic component fracture, which may subsequently require re-operation."
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STAR Ankle Fracture Symptoms
- New worsening pain
- Inability to bear weight
- New grinding or other noise
- Instability in the implant
Patients at the greatest risk of these 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.
What is the STAR Ankle?
The STAR Ankle is a non-cemented total ankle prosthetic (“artificial joint”) used to replace a painful arthritic ankle joint caused by osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis. The implant is comprised of a tibial plate, a mobile-bearing polyethylene component, and a talar component.
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FDA Recommendations
FDA has provided the following recommendations to help patients and healthcare providers 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.
"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.
Do I Have a STAR Ankle Replacement Lawsuit?
The Medical Device 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.
