Cartiva Recall Lawsuit Alleges Failed Toe Implant Had To Be Surgically Removed Days Before Manufacturer Acknowledged Defect

Although there were high failure rates with Cartiva toe implants, lawsuit alleges the manufacturer waited years to recall the devices.

According to allegations raised in a recently filed product liability lawsuit, a West Virginia woman had to have a failed Cartiva implant surgically removed just three weeks before the manufacturer finally decided to pull all of the devices from the market.

The complaint (PDF) was brought by Tammy May in the U.S. District Court for the Southern District of West Virginia on November 27, indicating that the named defendants, including Cartiva Inc., Wright Medical Group N.V. and Stryker B.V., knew or should have known about the high risk of shrinkage with their Cartiva implant, yet continued to market the product as a safe and effective treatment for degenerative arthritis in the big toe.

The Cartiva SCI was introduced in 2016, as a breakthrough alternative to big toe fusion surgery for individuals experiencing hallux limitus or hallux rigidus. However, post-marketing reports have indicated that the Cartiva failure rates are substantially higher than the manufacturers initially reported.

Although a number of Cartiva lawsuits have been filed by individuals like May over the past few years, and a number of published case reports have highlighted devastating complications patients were experienced, the manufacturers did not issue a Cartiva implant recall until October 31, 2024.

Stryker quietly removed Cartiva from the market and called for medical providers to return all existing devices, after acknowledging that patients were experiencing “higher-than-expected” failure rates compared to data the manufacturers used to obtain approval for the device in 2016.

These complications have included the need for revision or removal of the implant, subsidence, displacement, persistent pain, nerve damage and fragmentation.

In her Cartiva recall lawsuit, May indicates she suffered many of these injuries herself, after having the device implanted in April 2022, following a hallux rigidis diagnosis.

“Contrary to all representations by Defendants, the SCI has not been effective at alleviating pain or restoring range of motion,” May’s lawsuit states. “In fact, Plaintiff has suffered permanent restrictions in the use of (her) big toe; forced adaptations to account for this restriction in neighboring joints; increased wear and tear on other components of the foot and leg; and, limitations on footwear options and active recreational activities.”

Just three weeks before the Cartiva recall was announced, May had the implant surgically removed on October 9. However, she indicates that the manufacturers left the device on the market for years after learning about its high rate of failures.

“Prior to the implantation of Plaintiff’s SCI, Defendants were aware of higher than reported loss of toe mobility, pain and high failure rates of the SCI due to shrinkage, including but not limited to 144 adverse event reports in the Maude database with the majority of events attributed to implant loosening,” the lawsuit states. “The loosening is likely due to shrinkage of the implant that is well supported by peer-reviewed literature mentioned herein.”

The lawsuit alleges that the manufacturers knew about the problems before May received the implant in 2022, but sat on that information for as long as they could to increase profits, even taking over sales and distribution when doctors began to shy away from the implant due to its reported problems.

May’s complaint presents claims of strict products liability, negligent design, manufacture and/or distribution, misbranded and adulterated device, common law product liability and negligence, breach of warranty, and seeks both compensatory and punitive damages.

Cartiva Recall Lawyers

Following the decision to remove their product from the market, a growing number of individuals are now reaching out to lawyers to determine whether they may be eligible for financial compensation through a Cartiva recall lawsuit, claiming that they may have avoided injuries or the need for additional surgery if manufacturers had accurately disclosed the implant’s failure rates.

Claims are being investigated for individuals 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 recall lawyers provide free consultations and claim evaluations, with all claims are being pursued on a contingency fee basis, which means that there are no fees or expenses paid unless a Cartiva settlement or lawsuit payout is received.