Precice Stryde Lawsuit | Latest Updates

Precice Stryde Lawsuit Overview

The Precice Stryde lawsuits involve allegations against NuVasive regarding biocompatibility concerns with their implantable limb lengthening devices. Patients have reported pain and changes in surrounding bone and soft tissue after receiving these implants. 

The US Food & Drug Administration (FDA) has issued warnings about potential biocompatibility issues, particularly with the stainless steel (Biodur 108) versions of the devices.

Latest Precice Stryde Lawsuit Updates

• March 10, 2025 – The FDA continues to investigate reports of pain and changes in surrounding bone and soft tissue in patients with NuVasive Precice devices, particularly those made with stainless steel.
• July 8, 2023 – The FDA issued a Warning Letter stating that NuVasive Specialized Orthopedics is recalling multiple Precice System Devices due to potential biocompatibility concerns [1].
• April 2021 – NuVasive initiated a recall and manufacturer ship hold on their titanium Precice devices since the company was unaware of the cause of adverse events in the stainless steel products.
• February 2021 – NuVasive issued a nationwide recall for their stainless steel Precice System devices after patients reported pain and changes in the bone tissue around the device, including bony abnormalities between the nail segments.

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FDA Reports and Statistics

From January 2019 to February 2021, 90 Stryde nails were implanted in 63 patients, with 78 femur and 12 tibia implants.

Radiographic changes occurred in 73% of cases, with an average time to initial changes of 168 ± 108.1 days for femurs and 276 ± 126.8 days for tibias.

Late-onset pain was observed in 11.1% of femur lengthening surgeries, affecting 12.7% of patients, but all pain resolved after implant removal [2].

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The FDA has received reports of pain and changes in the surrounding bone and soft tissue in people implanted with the NuVasive Precice Unyte System, which is stainless steel (Biodur 108)-based, FDA said. These adverse events may be related to corrosion, wear, and unanticipated exposure of components that are undergoing compatibility testing. At this time, the FDA is uncertain if the root cause of these adverse events is due to the stainless-steel material or related to design features and materials common to all Precice plate implants.

Precice Stryde Injuries & Side Effects

NuVasive Precice devices have been associated with various complications related to biocompatibility issues, particularly in stainless steel models.

• Bone Abnormalities: Changes in bone structure and density around the implant.
• Pain: Late-onset pain, particularly around the telescoping junction of the implant.
• Tissue Degradation: Damage to soft tissue surrounding the implant.
• Corrosion Effects: Tissue reactions due to corrosion of the implant material.
• Necrosis: Tissue death around the implant site.

Do You Qualify for a Precice Stryde Lawsuit?

You may qualify for a Precice Stryde lawsuit if:

• You received a NuVasive Precice device implant.
• You experienced serious side effects including bone abnormalities, pain, tissue degradation, or other complications.
• The injuries required medical treatment or monitoring.
• You can provide medical documentation linking your injuries to the Precice device.

Evidence Required for a Precice Stryde Lawsuit

• Medical records documenting the implantation of a NuVasive Precice device
• Radiographic evidence showing bone or tissue changes
• Documentation of pain or other symptoms related to the implant
• Medical records showing treatment for complications

Damages You Can Recover

• Medical expenses for treatment of complications
• Lost wages due to inability to work
• Pain and suffering caused by device complications
• Costs for device removal or replacement surgeries

Precice Stryde Recall Information

• February 2021: NuVasive issued a nationwide recall for stainless steel Precice System devices after patients reported complications.
• April 2021: NuVasive initiated a recall and manufacturer ship hold on titanium Precice devices.
• July 8, 2021: The FDA flagged concerns over biocompatibility with NuVasive Precice devices.

Recalled devices include:

Stainless Steel (Biodur 108)-Based Precice Implants:

• Precice Bone Transport
• Precice Plate
• Precice Stryde

Titanium-Based Precice Devices:

• Precice Freedom
• Precice Intramedullary Limb Lengthening (IMLL) Device
• Precice Short
• Precice Unyte

These include low biologic activity, which reduces the growth of fibrous tissue and allows loosening of the prosthesis, the possibility of metallosis and related inflammation or other allergic reactions, as well as abrasion of the material during operation, the researchers from NIH concluded.

FDA Recommendation on NuVasive Medical Devices

For patients implanted with any of the above devices, doctors should check for changes in the surrounding bone and soft tissue during routine radiographic monitoring.

When patients have increased pain or other unexpected symptoms, doctors should perform additional radiographs and physical examinations, with special attention to the area surrounding the telescoping junction of the implant.

At this time and based on currently available information, early removal of non-painful, well-functioning Precice devices from asymptomatic patients prior to one-year post-implantation is not recommended, decisions about removing or exchanging the Precice device should be made by health care providers in consultation with the patient or caregiver on a case-by-case basis. The FDA said. 

Statute of Limitations for Precice Stryde Lawsuits

The statute of limitations for filing a Precice Stryde lawsuit varies by state. Most states allow between 1-3 years from the date of injury or from when you discovered (or reasonably should have discovered) that your injury was caused by the Precice device.

It’s crucial to consult with an attorney as soon as possible after experiencing complications to ensure your claim is filed within the appropriate timeframe. Failing to file within your state’s statute of limitations will likely result in your case being dismissed.

FAQs

1. What is the problem with Precice devices?

NuVasive Precice devices, particularly those made with stainless steel, have been linked to reports of pain and changes in surrounding bone and soft tissue. These adverse events may be related to corrosion, wear, and unanticipated exposure of components that are undergoing compatibility testing.

2. What is the Precice Stryde device used for?

Precice devices are used to lengthen the limb, shorten or compress the limb, or transport segments of long bones. They include adjustable rods that are placed inside a patient and are driven by an internal magnetic mechanism.

3. What is biocompatibility and why is it important?

Biocompatibility refers to how the materials and components of a medical device should interact with your body and its biological responses. Any medical device that comes in contact with the human body is required to undergo biocompatibility testing to determine the overall safety of the product and potential for adverse biological responses.

4. What side effects can occur from a non-biocompatible device?

Complications from a device that is not biocompatible may include bone abnormalities, pain, cancer, developmental effects, reproductive system effects, skin irritation or burns, and thrombosis.

5. Is the FDA recommending removal of Precice devices?

At this time, the FDA is not recommending early removal of devices in people who are not experiencing any reactions to their current stainless steel Precice devices. Decisions about removing or exchanging the Precice device should be made by healthcare providers in consultation with the patient on a case-by-case basis.

6. What compensation can be sought in a Precice Stryde lawsuit?

Compensation in a Precice Stryde lawsuit can include medical expenses, lost wages, pain and suffering, rehabilitation costs, and other related expenses. In some cases, punitive damages may also be awarded to penalize the manufacturer for negligence.

7. How long do I have to file a Precice Stryde lawsuit?

The time limit to file a Precice Stryde lawsuit, known as the statute of limitations, varies by state. It’s crucial to consult with a lawyer promptly to ensure your claim is filed within the legal timeframe to preserve your rights.

See all related medical device lawsuits our attorneys covered so far.

Get a Free Precice Stryde Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for injuries related to NuVasive Precice devices. Statutes of limitations vary by state, meaning you have only a limited time from the date of injury to file your claim.

Schmidt & Clark, LLP offers:

• Free, confidential consultations.
• No upfront costs or fees.
• Payment only if we win your case.

References

1. https://www.fda.gov/medical-devices/letters-health-care-providers/update-nuvasive-specialized-orthopedics-precice-devices-letter-health-care-providers
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC10628610/