Patients with ankle arthritis may need another painful surgery if their defective STAR Ankle Replacement breaks, which may occur in just 3 to 4 years, according to an FDA warning.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Stryker STAR Ankle Replacement induced injury cases in all 50 states. If you or somebody you know has been injured by a defective ankle replacement that broke, fractured or failed, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
FDA Warning for STAR Ankle Replacements
On March 15, 2021, the FDA issued a Safety Communication about the high risk of a plastic piece breaking on the Scandinavian Total Ankle Replacement devices (STAR Ankle), which may occur as early as 3 or 4 years after the device is implanted. Fracture of the plastic component may require another surgery to repair or replace the broken ankle implant.
Who Is Most At Risk of STAR Ankle Failure?
Patients most at risk of a broken STAR Ankle Replacement include:
- Patients with more active lifestyles
- Patients under 55 years old
- Patients with osteoarthritis (disease where the protective joint tissue breaks down and causes pain and swelling)
- Thinner (6mm) plastic components appear to be more prone to fracture
What is the STAR Ankle Replacement?
The Scandinavian Total Ankle Replacement System (“STAR Ankle”) is a non-cemented total ankle replacement (“prosthetic joint”) that is used to replace a painful ankle joint in patients with arthritis, osteoarthritis, or rheumatoid arthritis.
What is the Problem?
When the STAR Ankle was approved in May 2009, the FDA required the manufacturer to complete an 8-year safety study in patients who received the device. Unfortunately, that study showed a high rate of a plastic component breaking, often within a few years.
STAR Ankle Study Finds High Rate of Failure
In the long-term safety study, out of 87 patients, the plastic component fractured at a rate of 13.8% (12 out of 87 patients) at 8 years post-implantation, with all of the patients requiring additional surgery.
Some of the fractures occurred as early as 3 to 4 years after the STAR Ankle was implanted, which was unexpected. FDA officials called it “concerning” that there was a high rate of fractures, and early fractures, which is unusual compared to other ankle replacements.
Furthermore, the FDA was worried that fractures “may be underestimated,” because it can be hard for doctors to see a broken plastic component on a CT scan, so it may only be diagnosed during an exploratory surgery.
Over 300 Reports of Fractured STAR Ankle Replacements Since 2009
Since 2009, at least 1,841 adverse events have been reported for the STAR Ankle, and about 300 involved fractured plastic components.
In addition, the FDA reviewed reports on 244 STAR Ankle implants that were removed (including devices manufactured after the 2014 packaging change), which showed 72 plastic component fractures.
STAR Ankle Can Fail Within 3 or 4 Years After Surgery
Most of the plastic component fractures showed “material oxidation degradation after three to four years of implantation and exhibited loss of mechanical properties,” according to the FDA review of the reports.
The FDA concluded by warning patients about the risk of this severe side effect, which may require another surgery:
“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.”
What is Ankle Replacement Surgery?
Ankle replacement surgery is the when a doctor replaces a damaged ankle joint with an artificial implant. The STAR Ankle is used in patients with arthritis, which is a painful condition in which the soft cartilage on the surface of the bones wears away. People with ankle arthritis can suffer from pain, inflammation, and swelling of the joint.
Risks of Having Another Ankle Replacement Surgery
Patients who need another ankle replacement surgery due to a broken STAR Ankle face serious risks, including:
- Infection
- Nerve damage
- Bleeding
- Blood clots
- Bones not properly joining together
- Misalignment of the bones
- New arthritis
- Loosening of artificial ankle joint
- Early failure of the artificial joint
- Limited mobility
- Limp
- Chronic pain
Do I have a Stryker STAR Ankle Replacement Lawsuit?
The Schmidt Firm, PLLC is currently accepting Stryker STAR Ankle Replacement induced injury cases in all 50 states. If you or somebody you know has been injured by a defective ankle replacement that broke, fractured or failed, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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