STAR Ankle Replacement Lawsuit | 2025 Latest Updates

STAR Ankle Replacement Lawsuit Overview

The STAR Ankle (Scandinavian Total Ankle Replacement) lawsuits center on premature fracturing of the plastic component, sometimes occurring as early as 3 to 4 years after implantation. Primary allegations against manufacturer Stryker include failure to adequately warn patients about the high fracture risk. Since 2009, at least 1,841 adverse event reports have been linked to the STAR Ankle Replacement, with approximately 300 reports describing fractured plastic components. The FDA has issued warnings regarding the unexpected failure rate of these devices.

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Latest STAR Ankle Lawsuit Updates

September 6, 2023 – The Australian Therapeutic Goods Administration has issued a hazard alert concerning the STAR Ankle Prosthesis, emphasizing potential safety concerns and providing guidance for healthcare providers and patients [1].​

March 15, 2021 – FDA analysis confirms the potential risk of plastic component fractures exists for all STAR Ankle devices regardless of manufacture date, contradicting Stryker’s previous claims that only devices manufactured before August 2014 were affected; litigation references to this risk continued into August 2024.

March 15, 2021 – Long-term post-approval study results, from an 8-year follow-up of a pre-2009 cohort, revealed the plastic component of the STAR Ankle fractured at a rate of 13.8% (12/87) at 8 years post-implantation, with all fractures requiring additional surgery.

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FDA Reports and Statistics

According to FDA data:

• Since 2009, at least 1,841 adverse event reports have been filed related to STAR Ankle Replacements
• Approximately 300 reports specifically described fractured plastic components
• Review of 244 removed STAR Ankle devices found 72 plastic component fractures
• Fractures occurred more frequently in thinner plastic components (6mm thickness) compared to thicker components
• 13.8% fracture rate at 8 years post-implantation according to long-term study
• Most plastic component fractures showed material oxidation degradation after 3 to 4 years of implantation

STAR Ankle Injuries & Side Effects

STAR Ankle Replacement devices have been associated with several serious complications:

• Component Fracture: Unexpected breaking of the plastic polyethylene component
• Revision Surgery: Additional operations required to repair or replace fractured components
• Chronic Pain: New or worsening pain at the implant site
• Joint Instability: Inability to bear weight or instability in the ankle
• Mechanical Issues: Grinding, noise, or other mechanical problems with the implant

Do You Qualify for a STAR Ankle Replacement Lawsuit?

You may qualify for a STAR Ankle lawsuit if:

• You received a STAR Ankle Replacement device
• You experienced serious complications including component fracture, instability, or chronic pain
• Your complications required medical treatment or revision surgery
• You can provide medical documentation linking your injuries to the STAR Ankle device

Patients at highest risk include individuals with active lifestyles, those with osteoarthritis, or patients younger than 55 years old.

Evidence Required for a STAR Ankle Lawsuit

To strengthen your case, you’ll need to provide:

• Medical records documenting your original STAR Ankle implantation
• Evidence of complications or injuries related to the device
• Documentation of any revision surgeries or additional treatments
• Physician statements connecting your injuries to the STAR Ankle device

Damages You Can Recover

By filing a STAR Ankle lawsuit, you may be eligible to recover:

• Medical expenses for revision surgeries and additional treatments
• Lost wages due to recovery time and disability
• Pain and suffering resulting from complications
• Punitive damages against the manufacturer

STAR Ankle Recall Information

While there has not been a full recall of the STAR Ankle device, the FDA has issued warnings about the higher-than-expected fracture rates. The agency has noted that design changes made in 2014 to the packaging may not have fully resolved the fracture risk issues.

Statute of Limitations for STAR Ankle Lawsuits

The time you have to file a STAR Ankle lawsuit varies by state but generally ranges from 1-3 years from the date you discovered or should have reasonably discovered the connection between your injury and the device. Consulting with an attorney promptly is essential to ensure you don’t miss critical deadlines.

FAQs

1. What is the STAR Ankle Replacement device?

The STAR Ankle is a non-cemented total ankle prosthetic used to replace a painful arthritic ankle joint caused by osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis. The implant consists of a tibial plate, a mobile-bearing polyethylene component, and a talar component.

2. What are the main problems with STAR Ankle Replacements?

The primary issue is the premature fracturing of the plastic component, sometimes occurring as early as 3-4 years after implantation. FDA found a 13.8% fracture rate at 8 years post-implantation.

3. How do I know if my STAR Ankle is failing?

Warning signs include new or worsening pain, inability to bear weight, grinding or other noises, and instability in the implant. If you experience these symptoms, consult your healthcare provider immediately.

4. What should I do if I suspect my STAR Ankle is damaged?

Contact your healthcare provider for an examination, which may include X-rays or CT scans to determine if the plastic component is broken.

5. How much compensation can I receive from a STAR Ankle lawsuit?

Compensation varies based on factors including severity of injuries, medical costs, lost wages, and pain and suffering. Your attorney can provide a better estimate after reviewing your specific case.

6. Can I still join the lawsuit if my issues were mild?

Yes, even with mild complications you may be eligible to join the lawsuit and seek compensation for related costs and inconveniences.

7. What if my claim related to a STAR Ankle is denied?

If your claim is denied, consult with an attorney who can help challenge the denial and pursue further legal action.

8. How long does a STAR Ankle lawsuit typically take?

The timeline varies depending on case complexity, but medical device lawsuits typically take 1-3 years to resolve, whether through settlement or trial.

9. Is there a class action lawsuit for STAR Ankle replacements?

Currently, most STAR Ankle cases are being handled as individual lawsuits rather than class actions, allowing for compensation based on each person’s specific damages.

10. What makes the Schmidt & Clark, LLP firm qualified to handle my case?

Schmidt & Clark, LLP specializes in medical device litigation with experienced trial lawyers who focus on representing plaintiffs nationwide in cases like STAR Ankle Replacement lawsuits.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for STAR Ankle Replacement injuries, with many states only allowing 1-3 years from the date of injury or discovery to file your claim.

Schmidt & Clark, LLP, LLP offers:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees for our services
• Payment only if we win your case

Don’t delay seeking the compensation you deserve for your suffering and medical expenses.

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Reference:

[1] https://www.tga.gov.au/safety/market-actions/hazard-alert-scandinavian-total-ankle-replacement-star-ankle-prosthesis