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The Cartiva implant lawsuit involves allegations that a synthetic cartilage device marketed as an alternative to toe fusion surgery caused unexpectedly high rates of failure, leading many patients to undergo additional procedures and prolonged treatment.
Patients filing Cartiva implant claims allege that Cartiva toe implant failure resulted in persistent pain, loss of mobility, implant subsidence, bone damage, and revision surgeries that often ended with fusion of the big toe joint.
Injured patients across the country are now pursuing lawsuits against the manufacturers, claiming the risks and failure rates associated with the device were not adequately disclosed before implantation.
TorHoerman Law is actively accepting Cartiva implant cases from individuals across the country.
The Cartiva Synthetic Cartilage Implant (SCI) was introduced as an alternative to big toe fusion surgery for patients suffering from hallux rigidus, a painful form of arthritis affecting the big toe joint.
The device was intended to relieve pain while preserving motion, but many patients later reported complications that required additional foot and ankle surgery, implant removal, or conversion to fusion.
Cartiva implant claims allege that the device was associated with higher-than-expected failure rates, including implant shrinkage, subsidence into surrounding bone, persistent pain, and loss of joint function.
In 2024, Stryker initiated a Class II recall affecting all Cartiva implant sizes distributed since 2016 after identifying increased reports of revision procedures and complications including pain, nerve damage, fragmentation, and other serious adverse events.
When a Cartiva implant fails, patients may face months or years of additional treatment, worsening mobility limitations, and costly corrective procedures.
TorHoerman Law is seeking Cartiva implant cases involving revision surgery, implant removal, chronic pain, or other injuries allegedly linked to this device and other defective medical devices.
If you or a loved one experienced complications such as implant failure, persistent pain, or the need for revision surgery after receiving a Cartiva Synthetic Cartilage Implant (SCI), you may be eligible to file a Cartiva Implant Lawsuit and seek financial compensation.
Contact our team of Cartiva Implant Lawyers for a free consultation.
You can also use the chat feature on this page to find out if you’re eligible to file a Cartiva Implant Lawsuit instantly.
An Arizona woman has filed a lawsuit against Cartiva Inc., alleging that its synthetic cartilage toe implant failed years after implantation and ultimately required removal, toe-fusion surgery, and several additional procedures.
According to the complaint, Andrea Valentine received a Cartiva implant in her left big toe in December 2018 but experienced chronic pain, stiffness, and limited mobility until the device was removed in May 2024.
The lawsuit claims the failure caused bone loss and toe deformity, necessitating further surgeries.
Valentine alleges that Cartiva overstated the implant’s safety and effectiveness while downplaying reports of device failures from surgeons and patients.
The complaint cites FDA findings that reportedly showed significantly lower real-world success rates than those previously promoted before the device entered the market.
The implant was removed from the market in October 2024 after regulators reviewed an increasing number of adverse event reports.
The case has been transferred to the federal Cartiva multidistrict litigation in the Eastern District of Arkansas, where approximately 20 similar lawsuits are pending.
Valentine seeks compensatory and punitive damages, asserting claims of defective design, failure to warn, negligence, product liability, and breach of warranty.
The Cartiva toe implant litigation continues to grow as new lawsuits allege the device failed to deliver on promises of preserving joint motion and avoiding fusion surgery.
In a recently filed case, a West Virginia woman claims her Cartiva Synthetic Cartilage Implant failed within a year of implantation, causing chronic pain, stiffness, bone loss, and limited mobility.
According to the lawsuit, surgeons were ultimately forced to remove the implant and permanently fuse her big toe joint, the very outcome the device was marketed to help patients avoid.
The complaint comes amid increasing scrutiny of the Cartiva implant following the FDA’s 2024 recall and allegations that actual failure rates were significantly higher than those reported during the approval process.
Plaintiffs contend that Cartiva failed to adequately warn patients and physicians about risks including implant loosening, shrinkage, bone erosion, loss of motion, and the need for revision surgery.
The lawsuit will join the federal Cartiva multidistrict litigation (MDL) in Arkansas, where courts are preparing the litigation for coordinated discovery and future bellwether trials.
As more patients come forward reporting failed implants and subsequent fusion procedures, the outcomes of these early test cases could play a significant role in future settlement discussions.
The Cartiva toe implant litigation is rapidly expanding as more patients come forward alleging that the device failed at rates far higher than originally disclosed.
Following the FDA’s 2024 recall, more lawsuits have been filed, with plaintiffs claiming their complications were not isolated incidents but part of a broader pattern tied to the implant’s design.
Cartiva implant cases have now been consolidated into a multidistrict litigation (MDL) in Arkansas, where the court will oversee coordinated discovery and pretrial proceedings.
This process is designed to streamline common issues across cases and prepare a small group of representative lawsuits, known as bellwether trials, that will test how juries respond to the evidence.
The lawsuits center on allegations that the Cartiva synthetic cartilage implant, marketed as a mobility-preserving alternative to toe fusion surgery, instead failed prematurely in real-world use.
Plaintiffs report issues such as implant migration, joint damage, and worsening pain – often leading to additional surgeries, including the very fusion procedure the device was meant to avoid.
In one case, a plaintiff alleges the implant shifted out of place and deteriorated surrounding joint structures, ultimately requiring permanent fusion.
Claims like this are becoming more common as awareness of the recall spreads.
As the MDL moves forward, the key issue will be whether the manufacturer adequately disclosed the true failure rates and risks associated with the device.
A new product liability lawsuit filed in the U.S. District Court for the Eastern District of North Carolina alleges that Cartiva Inc. misrepresented the performance of its synthetic cartilage implant (SCI) for the big toe.
Plaintiff Marion Bhatt received a Cartiva implant in May 2018 for hallux limitus and hallux rigidus, degenerative arthritis conditions affecting the big toe.
The lawsuit claims the implant failed by May 2023, requiring revision and fusion surgery, followed by a second fusion procedure in August 2025.
The Cartiva implant, approved by the FDA in 2016, was marketed as a low-failure option based on the MOTION Study, a clinical trial of 152 procedures reporting no fragmentation, degradation, or bone loss.
Bhatt’s lawsuit contends that real-world outcomes diverged sharply from the trial, with higher Cartiva revision rates and reports of pain and bone damage.
By 2024, the manufacturer recalled the implant after acknowledging a “higher-than-expected” failure rate.
The complaint references internal knowledge and FDA adverse event reports indicating that the device failed at significantly higher rates than the 13.5% cited by the manufacturer.
A product liability lawsuit filed by Daniel Catanese in the U.S. District Court for the Northern District of Illinois claims his Cartiva Synthetic Cartilage Implant (SCI) migrated out of position, damaged surrounding joints, and ultimately required permanent big toe fusion.
The lawsuit, filed on March 6, 2026, identifies Cartiva Inc. as the sole defendant.
Cartiva SCI implants are polyvinyl alcohol-based hydrogel devices introduced in 2016 as an alternative to big toe fusion for hallux limitus or hallux rigidus.
The devices were intended to preserve flexibility while reducing arthritis-related pain.
The implant has been linked to high failure rates, worsening pain, decreased mobility, and bone erosion, leading to a Cartiva SCI recall in October 2024. Many patients required corrective toe fusion surgery after implant failure.
Catanese received a Cartiva SCI in late 2017.
He reports persistent pain and reduced range of motion despite steroid injections in October 2019 and additional treatments in February 2023.
After the Cartiva recall, surgical removal in November 2024 revealed that the implant had shifted laterally, hollowing out the lateral aspect of the metatarsal head and leaving the dorsal cortex unstable for any subsequent implant. Catanese underwent a bone graft and additional procedures to repair damage.
The lawsuit alleges Cartiva knew or should have known of implant risks, citing concerns about the clinical study used for FDA approval and claims that adverse events and failure rates were underreported.
Cartiva Synthetic Cartilage Implant (SCI) lawsuits are increasing nationwide following reports of high failure rates and severe complications.
Patients allege the polyvinyl alcohol-based hydrogel device, marketed as a motion-preserving alternative to big toe fusion for hallux rigidus, frequently failed to relieve pain, loosened, migrated, or subsided into surrounding bone.
Many required revision surgery or eventual big toe fusion, which permanently eliminates joint movement.
The Cartiva SCI was introduced in 2016 and recalled in October 2024 after post-market data revealed higher-than-expected complication rates. Reported complications include implant loosening, subsidence, displacement, persistent pain, nerve damage, stiffness, and fragmentation.
Studies and clinical reports suggest up to 45% of patients experienced adverse outcomes, substantially exceeding the failure rates initially reported during FDA approval.
Patients who received a Cartiva implant may have experienced revision or removal surgery, chronic pain, and long-term mobility limitations.
Surgeons were advised to monitor recipients for persistent toe pain, swelling, weakness, or restricted movement, and hospitals were instructed to remove remaining implants from inventory.
Federal judges will review whether all Cartiva Synthetic Cartilage Implant (SCI) lawsuits should be consolidated for coordinated pretrial proceedings.
Oral arguments before the U.S. Judicial Panel on Multidistrict Litigation (JPML) are scheduled for January 29, 2026, in San Diego, California.
The Cartiva SCI, approved by the FDA in 2016, was marketed as a motion-preserving alternative to big toe fusion for patients with hallux limitus or hallux rigidus.
Made from polyvinyl alcohol (PVA) hydrogel, the implant was designed to relieve pain while maintaining joint flexibility.
However, post-market data revealed significantly higher failure rates than initially reported, leading to a recall in October 2024.
While Cartiva initially claimed a 13% failure rate, later reports indicate failure may affect up to two-thirds of patients, often necessitating removal surgery and, in many cases, permanent big toe fusion.
Plaintiffs across at least five federal district courts allege the implant failed prematurely, causing loosening, subsidence, pain, and loss of mobility.
The lawsuits assert that the device was defectively designed and that the manufacturer failed to adequately warn patients and medical professionals of known risks.
Several plaintiffs petitioned the JPML for multidistrict litigation (MDL) status, arguing consolidation would streamline discovery, depositions, expert analysis, and pretrial proceedings while preventing inconsistent rulings across courts.
If the JPML approves the MDL, all current and future federal claims will be managed by a single judge for coordinated pretrial proceedings, including discovery and potential early bellwether cases.
A Chicago resident has filed a lawsuit against Cartiva Inc., claiming repeated failures of the Cartiva Synthetic Cartilage Implant (SCI) caused permanent injury.
Michelle Paulsen underwent implantation in both feet to treat hallux limitus and hallux rigidus, forms of degenerative arthritis affecting the big toe. Both implants required surgical removal after causing worsening pain and reduced mobility.
The lawsuit, filed November 13, 2025, in the U.S. District Court for the Northern District of Illinois, alleges Cartiva Inc. misrepresented the success rates of the toe implant to the FDA and the medical community.
The complaint states the manufacturer knew or should have known that design flaws in the PVA hydrogel–based implant contributed to an excessive failure rate but withheld this information from doctors and patients.
Cartiva SCI was FDA-approved in 2016 as an alternative to bone fusion, allowing patients to retain big toe flexibility. Reports of widespread failures prompted a national recall in October 2024.
Removal of the implant often required fusion surgery, the procedure patients had sought to avoid. Estimates suggest up to two-thirds of Cartiva toe implants may fail.
Paulsen’s complaint highlights that adverse effects—including loss of range of motion, bone erosion, implant shrinkage, and impaired walking—were not disclosed in patient materials.
Plaintiffs in multiple federal lawsuits over Cartiva Synthetic Cartilage Implant (SCI) failures have petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate the claims before a single judge in the Southern District of West Virginia.
Oral arguments are pending, and the panel will decide whether coordinated pretrial proceedings are appropriate.
The Cartiva SCI, approved by the FDA in 2016, was marketed as a polyvinyl alcohol (PVA) hydrogel implant designed to preserve big toe joint motion and reduce recovery time for patients with hallux limitus or hallux rigidus.
The device aimed to provide an alternative to traditional big toe fusion, which permanently restricts joint movement.
Following post-market reports and research, Cartiva Inc. issued a recall in October 2024, acknowledging a “higher-than-expected failure rate.”
While the company initially reported a 13% failure rate, later studies and surgeon data indicate that up to two-thirds of patients may experience complications, including implant loosening, subsidence, migration, persistent pain, and the need for revision surgery or permanent toe fusion.
Currently, at least seven federal lawsuits have been filed across five districts, with two in West Virginia and one in Maryland already progressing past initial complaints.
Plaintiffs allege nearly identical issues, asserting the device failed prematurely and caused severe pain, reduced mobility, and risky secondary surgeries.
The proposed MDL would consolidate discovery, pretrial motions, and settlement discussions while allowing each case to remain an individual lawsuit.
Cases not resolved through settlement could later return to their original courts for trial.
Lawyers representing plaintiffs in the Cartiva toe implant lawsuits have selected a settlement mediator to begin negotiations in March 2026.
The mediation will address claims involving the recalled Cartiva Synthetic Cartilage Implant (SCI), a polyvinyl alcohol-based device approved by the U.S. Food and Drug Administration (FDA) in 2016 for treatment of hallux limitus and hallux rigidus, degenerative forms of arthritis affecting the big toe joint.
The Cartiva SCI was designed as an alternative to traditional toe fusion surgery. Despite clinical trial data indicating a 13% failure rate, post-market reports revealed substantially higher rates of implant failure.
The FDA issued a nationwide recall in October 2024 after the company acknowledged elevated failure rates. Patients whose implants fail often require removal and subsequent toe fusion, permanently limiting mobility.
The first Cartiva lawsuit in this mediation phase was filed by Pennsylvania resident Robert J. Didonato.
The complaint alleges that Cartiva Inc. concealed evidence showing real-world failure rates approaching two-thirds of patients, while marketing the device as safe and effective.
The lawsuit seeks damages for persistent pain, reduced mobility, and related medical costs.
Didonato and Cartiva Inc. agreed to engage in formal mediation under the court’s Alternative Dispute Resolution (ADR) program before proceeding to a jury trial.
Judge Lisa Lenihan, a former U.S. magistrate judge in the Western District of Pennsylvania with 20 years of judicial experience, was selected to facilitate the mediation.
Parties will equally share mediation fees, and the initial session is scheduled for March 12, 2026.
The first Cartiva implant trial has been postponed until August 3, 2026, after U.S. District Judge Irene Berger of the Southern District of West Virginia granted a joint motion to extend pretrial proceedings.
The court has ordered the parties to engage in settlement discussions, which must conclude at least 30 days before the final pretrial conference scheduled for July 22, 2026.
A written status report is required within five days of completing mediation to inform the court whether a settlement was reached.
Cartiva toe implants are cylindrical devices made from polyvinyl alcohol-based hydrogel (PVA), marketed as an alternative to fusion surgery for hallux limitus or hallux rigidus.
Patients have reported high failure rates, including severe toe pain, implant loosening, and restricted mobility, often requiring removal and additional surgery.
The complications prompted a recall of Cartiva implants in late 2024.
The first trial involves Tammy May, who received a Cartiva implant in April 2022 to treat degenerative arthritis.
She underwent removal surgery in October 2024 due to severe pain and limited range of motion.
May’s claims, filed in December 2024, are expected to mirror testimony and evidence likely to appear in other Cartiva lawsuits nationwide.
The Cartiva Synthetic Cartilage Implant (SCI) received FDA approval in 2016 as a motion-preserving alternative to fusion surgery for patients suffering from hallux rigidus, a form of arthritis affecting the big toe joint.
The device was marketed as a way to maintain joint movement while reducing pain, but thousands of implants were distributed before reports began emerging of device failures, revision surgeries, and poor long-term outcomes.
Patients are filing lawsuits against the Cartiva implant manufacturer, alleging that the device was defectively designed and that they were not adequately warned about the risks of failure and complications.
Many plaintiffs claim they experienced persistent pain after implantation, while others report that the implant sinks into surrounding bone, loosens over time, or begins implant slipping within the joint.
In numerous cases, the only corrective option was to have the Cartiva implant removed and undergo revision surgery or fusion of the toe joint.
The litigation gained momentum following the Cartiva recall announced in October 2024.
The recall was prompted by post-market reports indicating that the Cartiva implant was failing at rates significantly higher than those represented during the initial FDA approval process.
The FDA’s recall notice identified risks including fragmentation, subsidence, and displacement of the implant.
Subsidence occurs when the implant sinks into the surrounding bone, while displacement refers to movement from its intended position within the joint.
As lawsuits increased nationwide, the Judicial Panel on Multidistrict Litigation centralized federal Cartiva cases on February 5, 2026, creating MDL No. 3172 in the United States District Court for the Eastern District of Arkansas.
The MDL allows federal courts to coordinate discovery and pretrial proceedings involving common factual allegations concerning the design, testing, marketing, and safety of the Cartiva implant.
Cartiva lawsuits allege that Cartiva, Wright Medical, and Stryker failed to adequately research the long-term performance of the device and neglected to warn physicians and patients about known risks.
Plaintiffs further allege that Cartiva and Stryker were aware of elevated failure rates but continued to market the implant using inaccurate or incomplete performance data.
Medical evidence cited in litigation includes adverse event reports, revision surgery findings, post-market surveillance data, and published studies documenting substantial rates of implant failure and conversion to fusion procedures.

Allegations in Cartiva Implant Lawsuits include:
Individuals who have experienced adverse outcomes with the Cartiva implant, such as persistent pain, implant displacement, or the need for additional surgical interventions, are pursuing legal action to seek compensation for medical expenses, pain and suffering, and other damages.
Cartiva Toe Implant Lawsuits aim to hold the manufacturers accountable for the alleged defects and failures associated with the Cartiva SCI.
If you or a loved one suffered complications, significant pain, device failure, or other health problems related to the Cartiva toe implant, you may be eligible to file a Cartiva Implant Lawsuit and seek compensation.
Contact a Cartiva Toe Implant Lawyer from TorHoerman Law today for a free consultation.
Use the chat feature on this page to find out if you qualify to join others filing Cartiva Implant Failure Lawsuits instantly.
In response to mounting evidence and patient complaints, Stryker Corporation, which acquired Cartiva, Inc., issued a recall of the Cartiva SCI in October 2024.
This recall encompassed all sizes of the implant sold since July 2016 and was prompted by higher-than-expected rates of complications, including implant failure and the necessity for revision surgeries.

The recall specifically includes the following Cartiva Synthetic Cartilage Implant (SCI) devices:
These devices were distributed from July 2016 to October 2024.
The Cartiva implant was originally developed and marketed by Cartiva, Inc., a medical device company focused on orthopedic solutions.
In 2018, Cartiva, Inc. was acquired by Wright Medical Group N.V., which then took over the manufacturing and distribution of the device.
Two years later, Wright Medical was purchased by Stryker Corporation, a global medical technology company that now assumes liability for the implant’s ongoing issues.
As a result, multiple companies are being named in lawsuits related to the failed Cartiva implant.

Companies Named in Cartiva Implant Lawsuits:
The Cartiva implant was developed to mimic natural cartilage and provide long-term relief from arthritis in the big toe joint.
However, many patients have reported serious complications after receiving the device.
One of the most common Cartiva implant problems is that the material, polyvinyl alcohol hydrogel, shrinks after implantation, causing the device to loosen and shift.
This migration often leads to joint instability, nerve damage, and severe toe pain.
The implant’s failure to integrate properly can also result in bone erosion, inflammation, and loss of mobility.
In many cases, the pain experienced after surgery is worse than before, forcing patients to undergo revision procedures such as toe fusion.
Some individuals develop infections, joint cysts, or abnormal bone growth due to the body’s reaction to the deteriorating implant.
These complications have raised significant safety concerns and prompted widespread litigation against the device’s manufacturers.

Injuries Linked to Cartiva Implant Device Failures:
Recognizing the early signs of a failed Cartiva implant is important for addressing complications before they worsen.
Patients with failed Cartiva implants often report symptoms such as swelling, difficulty walking, and loss of joint function, which can lead to further surgical interventions.
If left untreated, these symptoms can lead to permanent damage or the need for additional corrective procedures.

Patients experiencing the following symptoms should speak with their doctor as soon as possible:
These symptoms may indicate implant migration, joint damage, or failure of the device itself.
Early evaluation and treatment may help reduce further injury and prevent long-term complications.
If you received a Cartiva Synthetic Cartilage Implant (SCI) and later experienced complications, you may qualify for the Cartiva implant lawsuit.
The device was FDA approved in 2016 based on limited clinical trials, but many patients say their real-world experience did not reflect the data presented during the initial FDA approval process.
Individuals who suffered implant failure, required revision surgery, or endured ongoing pain after implantation may have a valid legal claim.
The Cartiva implant was marketed as a modern alternative to the existing fusion surgery technique used to treat big toe arthritis.
Unlike traditional joint fusion, the implant was supposed to preserve joint mobility while reducing pain.

However, recent medical research suggests that the implant may carry a much higher risk of failure than previously disclosed.
If you’ve undergone surgery to correct issues with your Cartiva implant or are experiencing worsening symptoms, you could be entitled to compensation.
A legal review can help determine if your case meets the criteria to join the growing number of Cartiva implant lawsuits being filed nationwide.
Contact our law firm for a free consultation, or use the chat feature on this page to find out if you qualify for the Cartiva Lawsuit instantly.
Strong evidence is essential to building a successful Cartiva Toe Implant Lawsuit.
Medical records, surgical notes, and proof of complications can help establish that the device failed and caused harm.
This documentation also connects your injuries to the implant, supporting claims of negligence or product defects.
The more detailed and organized your evidence, the stronger your case may be when seeking compensation.

Evidence in a Cartiva Toe Implant Case may include:
In a lawsuit, “damages” refer to the financial compensation a plaintiff seeks for the physical, emotional, and financial harm caused by a defective product or negligent action.
In the case of Cartiva implant failure lawsuits, damages aim to address the significant impact the failed device has had on the patient’s health, quality of life, and finances.
Compensation can be awarded for both economic losses—such as medical bills—and non-economic losses, like chronic pain or emotional distress.

Damages in a Cartiva Toe Implant Case may include:
If you or a loved one received a Cartiva big toe implant and are now experiencing severe pain, difficulty walking, or signs of nerve damage, you are not alone.
Many patients were promised relief and mobility through this alternative to joint fusion surgery—only to suffer complications that made their condition worse.
At TorHoerman Law, our legal team is actively reviewing claims on behalf of individuals harmed by the Cartiva implant and holding manufacturers accountable for the injuries caused.
TorHoerman Law is prepared to help you pursue the compensation you deserve.
We understand the toll a failed implant can take on your life—physically, emotionally, and financially—and we’re here to guide you through every step of the legal process.
Whether you’re dealing with ongoing pain, mobility issues, or have already undergone revision surgery, our firm is ready to help.

Contact a Cartiva Toe Implant Lawyer from TorHoerman Law today for a free consultation to discuss your legal options.
You may be eligible to file a claim and recover compensation for your medical expenses, lost wages, and suffering.
You can also use the chat feature on this page to find out if you qualify for a Cartiva Lawsuit instantly.
The Cartiva Implant Lawsuit involves legal claims filed by patients who suffered complications after receiving the Cartiva Synthetic Cartilage Implant (SCI) for arthritis in the big toe.
Plaintiffs allege that the device was defectively designed and prone to failure, causing severe pain, nerve damage, and the need for revision surgeries.
Cartiva Toe Implant Lawsuits also claim that the manufacturers misrepresented the safety and effectiveness of the implant during marketing and FDA approval.
Companies named in the lawsuits include Cartiva, Inc., Wright Medical Group, and Stryker Corporation.
Cartiva Lawsuits seek compensation for medical costs, lost income, and pain and suffering linked to the failed device.
Victims of failed Cartiva implants are seeking compensation for the physical, emotional, and financial harm caused by the defective device.
This includes reimbursement for medical expenses related to revision surgeries, ongoing treatment, and rehabilitation.
Many are also pursuing damages for lost wages, reduced earning capacity, and the long-term impact on their mobility and quality of life.
Non-economic damages like pain and suffering, emotional distress, and loss of enjoyment of life are also being claimed.
The Cartiva Synthetic Cartilage Implant has been linked to a range of serious injuries following implantation.
Many patients report worsening symptoms after surgery, including severe pain, joint instability, and loss of mobility.
In some cases, the implant shrinks or migrates from its original position, causing nerve damage and the need for additional surgery.
These complications can significantly impair a person’s ability to walk or perform daily activities.
Lawsuits allege that these injuries stem from defects in the device’s design and material.
Common Injuries Associated with Cartiva Implant Failure:
The Cartiva Implant Recall was issued in October 2024 after a growing number of patients reported serious complications following implantation of the device.
The recall affects the molded cylindrical implant used to treat arthritis in the big toe joint, known as the Cartiva Synthetic Cartilage Implant (SCI).
Stryker, the parent company of Cartiva, acknowledged that the medical device was associated with higher-than-expected failure rates, including implant loosening, bone damage, and the need for revision surgeries.
The recall instructs healthcare providers to stop using the device and return any unused inventory.
Physicians are also urged to monitor patients who received the implant for signs of failure, including severe pain, difficulty walking, or nerve damage.
The recall applies to all device sizes distributed since July 2016.
Recalled Cartiva Implant Models:
A failed Cartiva implant can cause a range of painful and disruptive symptoms that may worsen over time.
Patients often experience increasing discomfort and mobility issues in the big toe following what was meant to be a relief procedure.
These symptoms may signal implant loosening, bone damage, or nerve-related complications.
If you’re experiencing any of the following signs, it’s important to speak with a doctor as soon as possible.
Symptoms of a Failed Cartiva Implant:
Yes, the Cartiva Synthetic Cartilage Implant (SCI) was FDA approved in 2016.
The approval was granted based on the device’s performance in limited clinical trials, which suggested a lower failure rate and better joint mobility compared to traditional fusion surgery.
However, many experts now argue that the initial FDA approval was based on incomplete or overly optimistic data.
Since its approval, real-world outcomes have shown significantly higher Cartiva implant failure rates and complications than originally reported.
These discrepancies have raised concerns about the adequacy of the FDA’s review process and the long-term safety of the device.
There is currently no established average Cartiva implant lawsuit settlement amount.
As of February 2026, federal Cartiva lawsuits have been centralized into a multidistrict litigation (MDL) in the Eastern District of Arkansas, which may facilitate settlements for affected patients.
Because the litigation remains in its early stages, it is too soon to determine what individual settlements or any future settlement framework may look like.
If settlements are reached, compensation will likely depend on the severity of each person’s injuries and losses.
Settlement values in medical device cases often take into account the cost of revision surgery or implant removal, lost wages, future medical expenses, permanent mobility limitations, and pain and suffering.
Individuals who required multiple surgeries, experienced significant pain, or suffered long-term complications may have claims that differ substantially from those involving less severe injuries.
The strength of the underlying evidence may also affect case values.
Plaintiffs point to medical studies reporting Cartiva implant failure rates substantially higher than those presented during the FDA approval process, with some research finding failure rates approaching 79% within two years of implantation.
The 2024 Cartiva recall and subsequent federal litigation have increased scrutiny of the device’s long-term performance and the information provided to physicians and patients regarding potential risks.
The Cartiva Synthetic Cartilage Implant (SCI) is a small medical device made from polyvinyl alcohol (PVA) hydrogel, a biocompatible material designed to mimic many of the cushioning and load-bearing properties of natural cartilage.
Unlike metal or plastic joint implants, the hydrogel material contains a high percentage of water, giving it elasticity and compressibility similar to healthy cartilage tissue.
The device is manufactured as a molded cylindrical implant that is surgically inserted into the metatarsal head of the first metatarsophalangeal (MTP) joint, the joint located at the base of the big toe.
During the procedure, a surgeon removes a portion of the damaged joint surface and uses specialized instruments to place the implant into the prepared bone.
The Cartiva implant was designed to function as a motion-preserving alternative to fusion surgery for patients with hallux rigidus, a form of degenerative arthritis affecting the big toe.
By replacing damaged cartilage with a synthetic cushioning surface, the implant was intended to relieve pain while maintaining joint movement and allowing patients to continue using the toe more naturally than with a fused joint.
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