When a Cartiva toe implant fails, the claim in the current litigation is a product liability claim against the company that made the device, not a medical malpractice claim against your surgeon. The lawsuits allege the implant itself is flawed, so the defendant is the manufacturer, Cartiva, Inc., which has been part of Stryker since 2020. A claim against a surgeon is a separate case that fits only narrow situations.
That distinction sounds simple, but it is where many people get stuck. Some patients never call a lawyer because they do not want to sue the surgeon they trust. Others are not sure which company is responsible, since the implant has carried three corporate names in under a decade. And the choice of defendant quietly changes your deadline, the evidence that matters, and which court hears your case.
If your Cartiva implant has been removed, revised, or replaced with a fusion, a free Cartiva toe implant case review with Baker Legal Team can sort out who the right defendant is before a deadline runs. The review is led by a Board-Certified Civil Trial Lawyer whose practice is built on trying product liability cases against manufacturers. Here is how the question of Cartiva implant liability breaks down.
Key Insights
- A failed Cartiva implant is being litigated as a product liability claim against the manufacturer, not a malpractice claim against your surgeon.
- The lawsuits allege a flaw shared across the product line, which is why thousands of different surgeries were centralized into one federal MDL.
- The cases name Cartiva, Inc. as the defendant. Wright Medical bought Cartiva in 2018, and Stryker bought Wright Medical in 2020.
- In most states, a hospital or surgical center is not treated as the seller of an implant, but its records and the explanted device can be key evidence.
- A surgeon claim fits only when there is a separate error in your care. Device failure alone is not evidence of malpractice.
- The defendant you pursue changes your deadline, the evidence you need, and the court that hears your case.
Device-failure statements are allegations. The manufacturer disputes them, and causation has not been decided in court.
Is a Failed Cartiva Implant a Product Liability Case or a Malpractice Case?
A failed Cartiva implant is being litigated as a product liability case. The allegation is that the device was the problem, not the way one surgeon performed one operation.
The two claim types aim at different people and ask different questions. Mixing them up is the most common reason people assume they have no case, or the wrong one.
What a Product Liability Claim Targets
A product liability claim targets the company that designed, made, labeled, or sold a product. The question is whether the product itself was unreasonably dangerous or came without adequate warnings.
The surgeon’s skill is not on trial in this kind of case. If the device is alleged to share a flaw across every unit, a perfect surgery could still end in failure. For how defect claims are built and proven, see our guide on what happens when medical devices and watercraft fail.
What a Medical Malpractice Claim Targets
A medical malpractice claim targets a doctor, nurse, or facility for falling below the accepted standard of care. The question is whether a provider made a careless decision or error that caused your injury.
Malpractice is about conduct, not the product. A doctor can use a well-made device and still be negligent, and a doctor can do everything right with a device that is alleged to be defective.
| Question | Product Liability Claim | Medical Malpractice Claim |
|---|---|---|
| Who is sued? | The device manufacturer and related companies | The surgeon, other providers, or the facility |
| What is alleged? | The product was defective or inadequately labeled | A provider fell below the standard of care |
| What evidence matters most? | Design, testing, FDA submissions, complaint data, the explanted device | Your chart, the operative report, expert testimony on the standard of care |
| Where does the Cartiva litigation fall? | Yes The Cartiva lawsuits are filed as product liability claims against the manufacturer | Only in narrow, case-specific situations involving a separate error in care |
Why Is the Cartiva Litigation a Device Case?
The Cartiva litigation is a device case because the lawsuits allege a problem shared across the product line, not mistakes in individual operations. That shared allegation is what ties thousands of different surgeries together.
When the Judicial Panel on Multidistrict Litigation centralized the federal cases in February 2026, it described them as products liability actions sharing common questions about the implant. According to the JPML Transfer Order for MDL No. 3172, those questions include:
- Causation
- The manufacturer’s testing of the implant
- Whether the device’s labeling was sufficient
- What the manufacturer represented to the FDA during approval
- The circumstances of the device recall
Notice that none of those questions involve a particular surgeon. Every one of them points at the company and the product.
These are allegations. The manufacturer disputes them, and causation has not been decided in court. For where the case stands now, see our Cartiva lawsuit update.
Who Is the Defendant in a Cartiva Lawsuit?
The defendant named in Cartiva lawsuits is Cartiva, Inc., the company that developed the implant and obtained FDA approval in 2016. The cases listed in the JPML’s transfer order name Cartiva, Inc. as the defendant.
Patients often know a different name, usually Stryker or Wright Medical. That is because the company has changed hands twice.
Why the Company Name Keeps Changing
The Cartiva implant has had three corporate owners. Here is the chain in order:
- Cartiva, Inc. developed the synthetic cartilage implant and received FDA premarket approval in July 2016.
- Wright Medical Group acquired Cartiva, Inc. in 2018.
- Stryker acquired Wright Medical in 2020.
The October 2024 Class II recall came under Stryker’s ownership. The FDA recall record still lists Cartiva, Inc. as the recalling firm. For the recall details and the data behind it, see our breakdown of Cartiva implant failure rates.
Does Liability Follow a Company Through a Sale?
When a company is bought rather than dissolved, it generally keeps its legal obligations. Cartiva, Inc. was acquired, not shut down, so the company that made the device still exists to answer for it.
Whether a parent company like Wright Medical or Stryker can also be held responsible is a separate legal question. It depends on how each deal was structured and what each company did with the product afterward. That analysis belongs to your lawyer, not to the name on your surgical paperwork.
One more wrinkle: because the Cartiva implant reached the market through the FDA’s premarket approval process, federal law limits some state-law claims against its maker. How a device claim is framed around that rule is a key part of the lawyer’s job.
Can You Sue the Hospital or Surgical Center?
In most states, a hospital or surgical center is not treated as the seller of an implanted device, so it usually is not a product liability defendant. Courts in many states view the facility as providing medical services, with the implant as part of that service.
That rule varies by state, and a facility can still be responsible for its own staff’s negligence. But a failed implant alone does not usually make the hospital a defendant in a device claim.
Where the Facility Does Matter: Your Implant Records and the Explant
The facility matters most as a source of evidence. Hospitals and surgery centers typically keep the implant log, which records the device’s size, catalog number, and lot number.
If your implant was removed, the facility or its pathology lab may also have handled the explanted device. That physical evidence can be central to a product case. Our guide to Cartiva implant records and evidence explains how to request those records and why preservation matters.
When Could a Surgeon Claim Exist Alongside a Device Claim?
A claim against a surgeon can exist alongside a Cartiva device claim only when there is a separate, provable error in that patient’s care. Device failure by itself is not evidence that a surgeon did anything wrong.
The situations a lawyer might look at are narrow. They are fact-specific, and none of them apply automatically:
-
01
Informed Consent
Whether known risks were explained before surgery.
-
02
Surgical Technique
Whether the implant was sized or placed in a way that fell below the standard of care.
-
03
Timing
Whether a device was used after the provider had notice of the recall.
-
04
Follow-Up Care
Whether signs of failure were missed or treatment was unreasonably delayed.
For most patients, none of these will apply. Your surgeon may simply be a witness whose records help prove the device claim.
Why This Call Needs a Lawyer
Deciding whether a surgeon claim exists is not something to guess at. In most states, including Florida, a manufacturer’s duty to warn about a prescription device runs to the physician, under what is called the learned intermediary doctrine.
That means what your surgeon knew, and when, can become evidence in the device case. Manufacturers also sometimes argue that surgical error, not the product, caused a failure. A lawyer who handles device cases knows how to answer that argument without pointing a finger at a doctor who did nothing wrong.
How Does the Defendant Change Your Deadline, Evidence, and Court?
The defendant you pursue determines which deadline applies, what proof you need, and which court can hear the case. Choosing wrong can cost you time you cannot get back.
| Factor | Device Claim Against the Manufacturer | Malpractice Claim Against a Provider |
|---|---|---|
| Deadline | Product liability statute of limitations and repose, which vary by state | A separate medical malpractice limitations period, with its own triggers and rules |
| Steps before filing | Generally no special presuit process | In Florida, a notice of intent and a verified medical expert opinion before suit |
| Key evidence | Device identification, the explant, company testing and FDA records | Your chart and expert testimony on the standard of care |
| Likely court | Federal MDL No. 3172 or state court, depending on the case | Usually state court where the care was provided |
Florida’s presuit requirements for medical negligence claims are set out in Florida Statutes section 766.203. Device claims follow a different track.
For the specific time limits on a device claim, see our guide to Cartiva lawsuit filing deadlines. For how venue works, see Cartiva MDL vs. state court.
What Should You Do If You’re Not Sure Who Is Responsible?
If you are unsure who is responsible for your failed implant, start by confirming the device and protecting the evidence. You do not need to decide the defendant yourself.
- Confirm your implant. Ask your surgeon’s office or the facility for the implant log or device sticker showing it was a Cartiva implant.
- Request your records. Get the operative reports for the original surgery and any revision or fusion.
- Ask about the explant. If the implant was removed, ask whether it was kept and where.
- Write down your timeline. Note when symptoms started and when you first linked them to the implant.
- Hold off on complaints or demands. Do not send letters to your surgeon or the manufacturer before speaking with a lawyer.
- Get a case review. A product liability lawyer can identify the right defendant and the deadline that applies.
If you are wondering whether your situation fits at all, our guide on whether you qualify for a Cartiva lawsuit walks through the criteria. For the factors that shape compensation, see what a Cartiva claim is worth.
Why a Product Liability Trial Lawyer, Not a General Injury Intake
A device case calls for a lawyer who has taken manufacturers to trial. Product liability claims turn on engineering, regulatory history, and corporate records, not just medical bills.
Robert B. Baker has been a Board-Certified Civil Trial Lawyer with The Florida Bar since 2002, a credential held by fewer than 1% of Florida attorneys. He won a $39 million verdict in Archer and Perez v. Yamaha against a personal watercraft manufacturer, and he served as State Liaison Counsel in a defective breast implant MDL.
That background matters here. Telling a device claim apart from a malpractice claim, and building the right one, is the kind of judgment that comes from trying product cases. For what to look for in counsel, see how to choose a Cartiva lawyer.
Past results do not guarantee a similar outcome in any future case.
Bottom Line
Cartiva implant liability points at the manufacturer, not your surgeon. The lawsuits allege the device itself is flawed, and the company named in them is Cartiva, Inc., now part of Stryker.
Hospitals are usually not defendants, and surgeon claims fit only rare, separate errors in care. Because the defendant controls your deadline, evidence, and court, the safest step is a free Cartiva case review before time runs out.
Frequently Asked Questions
Can I sue my surgeon if my Cartiva implant failed?
You can sue your surgeon over a failed Cartiva implant only if there is a separate error in your care, such as a problem with informed consent or a delayed diagnosis. The implant failing is not, by itself, evidence of malpractice. The Cartiva lawsuits are directed at the manufacturer.
Do I have to sue my doctor to file a Cartiva claim?
No, you do not have to sue your doctor to file a Cartiva claim. Cartiva claims are product liability claims against the device manufacturer. Your surgeon is usually involved only as a source of records or as a witness.
Is Stryker responsible for the Cartiva implant?
Whether Stryker is responsible for the Cartiva implant depends on corporate structure. Stryker has owned Cartiva, Inc. through Wright Medical since 2020, and the recall was issued under its ownership. The filed cases name Cartiva, Inc. Whether a parent company also bears liability is a legal question for your lawyer.
Does the recall prove the implant was defective?
No, the recall does not prove the implant was defective. The October 2024 Class II recall states that the implant may experience certain problems at a higher-than-expected rate. Lawsuits allege a defect, the manufacturer disputes those claims, and causation has not been decided in court.
Can I have both a malpractice claim and a product liability claim?
Yes, you can have both a malpractice claim and a product liability claim, but only in unusual situations. The two claims would have different deadlines, different proof, and possibly different courts. A lawyer should evaluate both before anything is filed.
Will my surgeon be involved in my Cartiva case?
Your surgeon may be involved in your Cartiva case as a witness, not a defendant. Their records help confirm the device and document what happened. In device cases, what the surgeon was told about the implant’s risks can also become evidence.
This article provides general information, not legal advice. Every claim requires an individual review of its facts. Reading this article does not create an attorney-client relationship.