Cartiva Implant Lawsuit

Cartiva Implant Failure Lawsuit Overview

Since 2016, the Cartiva toe implants have been promoted as an alternative to big toe fusion surgery and hailed by the manufacturer as a revolutionary toe implant designed to provide pain relief for individuals suffering from degraded cartilage in the big toe joint.

However, only a few years it was introduced, toe implant patients began reporting high rates of Cartiva surgery complications, including severe toe pain, loosening, fracture and subsidence, which is where the implant slips into the bone.

As a result, individuals across the U.S. are now pursuing Cartiva lawsuits against the manufacturer, claiming a defective design makes the toe implant prone to fail and cause severe pain, often resulting in the need for additional surgery and long-term disability.

Who May Be Eligible for a Cartiva Implant Lawsuit Payout?

Financial compensation may be available through a Cartiva implant failure lawsuit settlement for individuals who who received a failed Cartiva implant and experienced any of the following complications:

• Implant Failure/Fracture
• Subsidence (implant sinks into the bone)
• Toe Fusion Surgery
• Replacement Surgery
• Revision Surgery

Cartiva implant lawyers are reviewing lawsuits on a contingency fee basis, which means that there are no fees or expenses paid unless a Cartiva settlement or lawsuit payout is received.

Latest Cartiva Implant Lawsuit Update 2024

• November 4, 2024 Update: The findings of a study published last week in the October issue of Foot and Ankle surgery have bolstered claims being raised in Cartiva implant failure lawsuits, after researchers found nearly 30% of Cartiva patients required secondary operations, compared to 0% of joint fusion patients.
• October 1, 2024 Update: U.S. District Judge John T. Copenhaver, Jr., of the Southern District of West Virginia, issued an order (PDF)  scheduling a trial date for next year, in a Cartiva lawsuit filed by a Bryan Hughes, who indicates that his synthetic cartilage toe implant failed less than four years after it was placed in his foot, due to a defective design that has also caused other individuals nationwide to experience similar problems.
• April 24, 2024 Update: A Cartiva toe implant failure lawsuit was filed by Cathy Coleman in the U.S. District Court for the Northern District of Texas on April 22, indicating that the device was supposed to address arthritis in her big toe, but instead resulted in the need for multiple surgeries, including a toe fusion.
• January 19, 2023 Update: A series of voluntarily dismissals have been entered in early lawsuits filed, allowing plaintiffs to refile their claims in the future, and raising speculation of Cartiva toe implant settlements or an agreement to toll the statute of limitations may have been confidentially reached.

Cartiva Implant Background and FDA Approval

Approximately 2.2 million people in the U.S. suffer from conditions known as hallux limitus or hallux rigidus, which are forms of degenerative arthritis in the first joint of the big toe, known as the first metatarsophalangeal joint. The conditions cause the cartilage in that joint to degrade, which can result in severe pain and limited range of motion in the big toe.

Prior to Cartiva, the only treatment option was to remove the deteriorated big toe joint and fuse the toe bones together, a procedure known as big toe fusion or arthrodesis.

The Cartiva Synthetic Cartilage Implant was introduced in 2015, as an alternative to arthrodesis, involving a cylindrical implant made of polyvinyl alcohol-based hydrogel (PVA) designed to provide a gel-like cushioning to replace the degraded cartilage in the big toe joint. The implant was promoted as a revolutionary alternative to patients facing big toe fusion surgery, and was advertised by the manufacturer as safe and effective.

The Cartiva implant first received initial FDA approval in 2016, based on the results of the clinical trial known as the “Motion” study. The Motion study claimed that the Cartiva toe implant was “substantially equivalent” to the existing fusion surgery technique in treating patients with damaged or deteriorated cartilage in the first metatarsophalangeal joint. The study also claimed there was only a 13.5% Cartiva implant failure rate.

Real-world patient outcomes have demonstrated much higher Cartiva toe implant failure rates, with patients reporting alarming rates of complications, which have included severe toe pain, loosening, fracturing and subsidence, which is when the implant sinks into the bone.

Why Does The Cartiva Implant Fail?

Medical experts have offered several theories on why the Cartiva implant fails. Some of the most compelling arguments made for why the implant fails have included:

• Improperly Textured – Experts have suggested the round smooth surface of the device on all surrounding sides may allow the device to move. This can result in implant loosening that causes joint failure.
• Cartiva Implant Shrinking– Studies have indicated the water-based Cartiva implant may shrink once implanted due to the lack of hydration. This may allow the implant to loosen and slip into the bone (subsidence).
• Bone Weakening Around The Implant – Experts have also theorized that the implant was not designed properly to withstand the surrounding bone being weakened by arthritis, the condition in which Cartiva was designed to treat. The lack of supporting bone combined with the improperly textured or shrinking device could allow the implant to loosen and slip into the bone.

Manufacturers Withheld Information on Cartiva Implant Failures

In several Cartiva implant failure lawsuits that have been filed to date, individuals have raised allegations against Cartiva Inc., Wright Medical Group and Stryker, claiming the manufacturers have withheld information for years about the increasing number of Cartiva implant failures, in an attempt to avoid a Cartiva recall and increase profits.

Lawsuits have claimed each of the manufacturers, that either currently own Cartiva (Stryker), or previously owned Cartiva since 2016 (Cartiva Inc. and Wright Medical Group), were aware of higher failure rates than the 13% failure rate disclosed to patients.

Plaintiff’s have argued that the medical device company had exclusive knowledge of the potential Cartiva defects, citing more than 144 adverse event reports regarding loss of toe mobility, pain and high failure rates filed with the FDA. In addition to the FDA reports, multiple studies have been published outlining the increasing rate of implant failures and complications.

However, rather than the manufacturers fulfilling their legal obligations to report the increasing rate of Cartiva implant failures and complications to the FDA, and warning the public, the medical device companies chose to take no action to protect patients.

Cartiva Implant Failure and Complication Studies

Several follow-up studies and case reports have never been able to duplicate the results of the Cartiva Motion clinical trial. In fact, research published in medical journals have suggested Cartiva implant failure rates may be upward of 6 times higher than the manufacturer previously reported.

Nearly 30% of Cartiva Implant Recipients Required Revision/Removal Surgery

The October 2024 issue of Foot and Ankle Surgery featured a retrospective cohort study by T.L. Lewis and colleagues, examining the clinical outcomes of the Cartiva Synthetic Cartilage Implant (SCI) versus arthrodesis (joint fusion) in treating hallux rigidus.

The research tracked 33 patients who underwent either the Cartiva SCI procedure or joint fusion surgery, assessing patient-reported outcome measures (PROM) over an average follow-up period of 2.3 years.

Findings revealed a 29.4% reoperation rate for patients with the Cartiva implant compared to a 0% reoperation rate in the arthrodesis (joint fusion) group, suggesting concerns about the implant’s durability or effectiveness.

Ultimately, the study concluded that the Cartiva implant did not perform better than joint fusion surgery based on revision and removal surgery rates, as well as overall patient feedback. The researchers indicated arthrodesis emerged as the preferred treatment option for hallux rigidus.

50% of Cartiva Recipients Continue to Suffer From Stiffness or Reduced Movement

In a study published in the medical journal Cureus on November 19, 2023, U.K. researchers discovered that nearly 50% of Cartiva toe implant patients experienced complications, with almost 20% requiring reoperations or revisions.

The study revealed significant complications associated with Cartiva toe surgery. Nearly half of the Cartiva patients (45.5%) experienced various issues, including medical, surgical, and implant-related complications. More than half of the patients (55%) continued to feel pain at the final follow-up. Other post-operative issues included neurovascular symptoms (15%), stiffness or reduced mobility (50%), and swelling (10%).

Persistent pain after the operation was common, often necessitating additional treatments like orthotics, debridement, and implant repositioning. Notably, 18.4% of the patients (4 out of 22) required further surgeries, with two undergoing revision surgery to remove the Cartiva implants.

Complications reported included stitch abscesses, superficial infections, oozing wounds, and skin blistering. The researchers highlighted that satisfaction levels among patients were low, with only 36.4% expressing satisfaction with their surgery outcomes, while 27% reported dissatisfaction.

Cartiva Causes Increased Post Operative Pain Compared to Arthrodesis

Preliminary findings of an ongoing study published in the medical journal Foot & Ankle International found patients who received the Cartiva toe implant were more likely to report more post-operative pain.

The study reviewed 100 patients who underwent either Cartiva hemiarthroplasty, arthrodesis (fusing of the joint), or interpositional arthroplasty, finding Cartiva patients reported a worse overall combination of postoperative pain, function, and alignment when compared to patients who received the alternative treatments.

79% of Cartiva Implants Failed Within Two Years

A study published by the American Orthopedic Foot and Ankle Society indicates patients receiving Cartiva implants for the treatment of hallux rigidus face a 79% implant failure risk within two years of receiving Cartiva.

Researchers found 64% of patients who received a Cartiva implant for hallux rigidus experienced device failure within four weeks of the surgery. The study found the risk of failure increased as time passed, reporting a 79% Cartiva failure rate in patients by 19 months post-surgery.

The most commonly reported reason for Cartiva failure was subsidence, in which the implant loosened and was able to sink into the toe bone resulting in severe toe pain and revision surgery in some cases.

The study further revealed 43% of patients reported the Cartiva implant offered no benefit in relieving toe pain or increasing mobility within the 19 month follow-up.

Nearly A Third of Cartiva Recipients Dissatisfied With Outcome

In another study published by the American Orthopedic Foot and Ankle Society, researchers from Cedar Sinai Hospital found that 30% of Cartiva SCI recipients were either dissatisfied or very dissatisfied with the outcomes of the procedure.

The study found 50% of Cartiva patients required a corticosteroid injection after receiving the implant, in which researchers concluded the Cartiva implant only yielded modest patient satisfaction, with a large proportion requiring further treatment and workup post operatively.

Examples of Cartiva Toe Implant Lawsuits

February 2023: Cartiva Toe Implant Medical Malpractice Lawsuit. Eugene Perez filed a Cartiva toe implant lawsuit against the medical providers who recommended the use of a Cartiva implant for his big toe pain caused by a condition known as hallux rigidus. Perez claims the medical providers breached their standard of care by recommending a Cartiva implant since the device contains a flawed design, is prone to failure, and was not appropriate for treating his condition.

October 2022: Cartiva Lawsuit Over Failure Two Years After Toe Implant Surgery Cathy Atkinson filed a lawsuit against Cartiva manufacturers in the U.S. District Court for the Western District of Texas, claiming she received a defectively designed Cartiva implant that failed, resulting in the need for additional surgeries. Atkinson received a Cartiva implant in November 2018, which failed only two years later, requiring Cartiva removal surgery in December 2020 and the need for arthrodesis fusion surgery in 2021.

Have a Cartiva Implant Lawyer Review Your Case

If you or a loved one received a Cartiva toe implant and experienced complications resulting in the need for revision surgery, replacement surgery or big toe fusion, submit information about your potential claim for review by a Cartiva lawyer to determine whether a settlement or lawsuit payout may be available.

Lawyers provide free claim evaluations and consultations. There are no fees or expenses unless a recovery is obtained in your case.