Cartiva Toe Implant Lawsuit Information
Cartiva Lawsuit Overview
Since 2016, the Cartiva synthetic cartilage implant has 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 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 lawsuit settlement for individuals who who received the big toe 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.
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Lawyers are reviewing Cartiva lawsuits for individuals who experienced complications after receiving the toe implant. Settlement benefits may be available.See if you Qualify for a Settlement
Latest Cartiva Lawsuit Update 2023
December 2022 Update: In the latest of at least six Cartiva toe implant lawsuits brought this year, a Texas woman filed a product liability lawsuit against Stryker B.V., Wright Medical Group, N.V. and Cartiva, Inc., claiming the companies negligently offered a defective medical device to consumers and failed to disclose known risks.
November 2022 Update: Over the last several years a growing number of private orthopedic practices have publicly expressed concerns about the high rate of Cartiva implant failure in patients. Many practices have largely abandoned the use of Cartiva due to the high failure rate, choosing alternative treatment options with better success.
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 premarket approval from the U.S. Food and Drug Administration 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 big toe fusion surgery 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 lawsuits that have been filed throughout 2022, 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 manufacturer 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 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.
November 2022: 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.
October 2020: 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% 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.
October 2019: 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% 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.
Share Your Story
Did you experience Cartiva complications? Share your story with the AboutLawsuits.com community and have your comments reviewed by a lawyer to determine if you may be eligible for a lawsuit.
Examples of Cartiva Lawsuits
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 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.