Injury guide

Toe implant removal

Updated Oct 6, 202620 sources

When a Cartiva big-toe implant fails, a surgeon may take it out and fuse the joint. Here is how that works, which records matter and what the Cartiva lawsuits claim.

What the public record says

These are cited sources. Their inclusion does not imply that they endorse People’s Justice or reviewed this page.

U.S. Judicial Panel on Multidistrict Litigation · Summary of the claims (MDL No. 3172), not a ruling

“Plaintiffs allege that their Cartiva SCI was defective, that they experienced persistent pain and limited range of motion following implantation, and that they required additional surgery to remove their failed implant and fuse the arthritic joint.”

JPML transfer order, Cartiva MDL No. 3172 (Feb. 5, 2026) (opens in a new tab) · Feb 5, 2026 · Checked Oct 6, 2026

U.S. Food and Drug Administration · Reviewer of the Cartiva approval (PMA P150017)

Finding: In the approval trial, 14 of 152 Cartiva patients (9.2%) had the implant removed during the 24-month study, and every removed implant was converted to fusion without event. For the 50 fusion patients, the summary reports hardware removal in 5 (10%) in its conclusions and in 4 (8%) in its results.

FDA: Cartiva implant safety and effectiveness summary (P150017) (opens in a new tab) · Jul 1, 2016 · Checked Oct 6, 2026

The evidence and its limits

Dalhousie University · Foot & Ankle Specialist · 2025

Failures of Polyvinyl Alcohol Hydrogel Implant for Hallux Rigidus and Outcomes of Revision to Arthrodesis: Mid-Term to Long-Term Results

Design:
Cohort
Participants:
173 gel big-toe implants placed from 2009 to 2021; the study looked at 16 that failed and were changed to fusions.
Finding:
The authors estimated that about 84 of 100 implants at this center lasted 12 years without another surgery. In 4 of the 16 fusions after a failed implant, the bones did not join and more surgery was needed. These fusions had more such problems and worse function than first-time fusions.
Main limitation
One center looking back at charts (Level IV). Only the abstract was read.

Read the source: Failures of Polyvinyl Alcohol Hydrogel Implant for Hallux Rigidus and Outcomes of Revision to Arthrodesis: Mid-Term to Long-Term Results (opens in a new tab) · Checked Oct 6, 2026

NYU Langone Health · European Journal of Orthopaedic Surgery & Traumatology · 2024

Polyvinyl alcohol hydrogel implant for the treatment of hallux rigidus is associated with a high complication rate and moderate failure rate at short-term follow-up: a systematic review

Design:
Meta-analysis
Participants:
A review of 18 studies: 1,349 implant patients, 322 fusion patients and 168 bone spur removal patients.
Finding:
Reported failure was 14.8% for the implant (followed about two years on average), 9.0% for fusion and 0.3% for bone spur removal.
Main limitation
A review of other studies, with short follow-up (Level IV). Only the abstract was read.

Read the source: Polyvinyl alcohol hydrogel implant for the treatment of hallux rigidus is associated with a high complication rate and moderate failure rate at short-term follow-up: a systematic review (opens in a new tab) · Checked Oct 6, 2026

The short answer

What is toe implant removal, and why is it done?
Cartiva is a small implant placed in the joint at the base of the big toe. It was used for arthritis that makes that joint stiff and sore. If the implant fails, a surgeon may take it out and fuse the joint so the bones grow into one. [1]
When should I talk to my doctor about toe implant removal?
Talk to your foot surgeon if your big toe has new or worse pain, stiffness, swelling or weakness, or if walking gets hard. Doctors were told to watch for these signs after the recall. Only you and your surgeon can decide if the implant should come out. [2]
How is the implant removed, and how are problems treated?
The surgeon takes out the implant. To fuse the joint, the damaged cartilage is removed, and pins, screws or a plate hold the bones still. Over time the bones grow together, so the toe joint no longer bends. [3]
Which records matter after toe implant removal?
Ask for the operative report from the removal. Federal hospital rules say the surgeon writes or dictates it right after surgery and signs it. It notes what was found and what tissue was removed or changed. [4]

What rules a case out

Not covered by this case

  • This page is not medical advice. Your foot surgeon is the one to ask about your toe.
  • It does not cover other big-toe implants, bunion surgery or first-time fusions.

What is toe implant removal, and why is it done?

Cartiva is a small implant placed in the joint at the base of the big toe. It was used for arthritis that makes that joint stiff and sore. If the implant fails, a surgeon may take it out and fuse the joint so the bones grow into one.

The implant is a tiny gel cylinder made from a kind of plastic and salt water. It is pressed into the end of the long foot bone at the big-toe joint. FDA approved it in 2016 as another choice besides fusion. It does not grow new cartilage.

FDA’s 2016 review lists loosening, sinking into the bone, and a switch to fusion among the possible risks. In October 2024 the maker began a recall of every lot sent out from July 2016 to October 2024. It said people may have more removals, sinking, pain or nerve damage than expected.

When should I talk to my doctor about toe implant removal?

Talk to your foot surgeon if your big toe has new or worse pain, stiffness, swelling or weakness, or if walking gets hard. Doctors were told to watch for these signs after the recall. Only you and your surgeon can decide if the implant should come out.

A recall does not mean every implant must be removed. FDA says companies often ask doctors to talk with patients about the risk of taking a device out compared with leaving it in. Never have a device removed just for a lawsuit.

AAOS says taking out big-toe joint replacement implants in a later surgery can cause a lot of bone loss. Write down your questions before the visit, and ask what your X-rays show.

How is the implant removed, and how are problems treated?

The surgeon takes out the implant. To fuse the joint, the damaged cartilage is removed, and pins, screws or a plate hold the bones still. Over time the bones grow together, so the toe joint no longer bends.

AAOS calls fusion the most reliable way to ease pain from severe big-toe arthritis. After a fusion, most people wear a splint or cast for about six weeks. Swelling can last three to six months.

Which records matter after toe implant removal?

Ask for the operative report from the removal. Federal hospital rules say the surgeon writes or dictates it right after surgery and signs it. It notes what was found and what tissue was removed or changed.

Also get the record from your first toe surgery, when the implant went in. A device label shows a code called a UDI that names the exact model. FDA’s recall record lists a code for each Cartiva size, and anyone can look codes up in AccessGUDID.

Was the implant kept after it came out? Ask the hospital, and ask where it went. FDA’s MedWatch form asks whether a device is still available to be examined. The judge in the Cartiva cases asked the lawyers to keep working on whether and how removed implants are kept.

If the implant or tissue went to a lab, ask for the lab’s report, called a pathology report. It says what the lab saw by eye and under a microscope. You can get copies of your own records, X-rays included. To ask for them in writing, try our records request tool.

The Cartiva case page also has a longer guide to removal and fusion records.

What does research say about Cartiva implants and removal?

In FDA’s two-year trial, 14 of 152 people with the implant had it taken out. Of 50 people with a fusion, 4 or 5 had the fusion hardware taken out; FDA’s summary gives both numbers. FDA says each implant that came out was changed to a fusion without problems. Studies describe groups, not why one person’s implant failed.

A New York review of 18 studies followed implant patients for about two years on average. Across these studies, failure was reported in 14.8% of 1,349 implant patients, 9.0% of 322 fusion patients and 0.3% of 168 bone spur removal patients.

A fusion after a failed implant may not go as well as a first-time fusion. A Canadian study found more bones that did not join, and worse function, in that group.

The federal Cartiva cases are at an early stage. In the federal court records we read, we found no ruling on whether the implant caused anyone’s harm.

Who brings Cartiva toe implant claims?

People who had a Cartiva implant brought these federal cases. They claim it was defective and caused lasting pain and stiffness, and that they needed more surgery to remove it and fuse the joint. A lawyer can look at your records and tell you if you may have a claim.

In February 2026 the federal cases were grouped before one judge in Arkansas. The Cartiva case page explains where they stand now.

Can a family member get records after toe implant removal?

Sometimes. HIPAA lets a personal representative ask for records as if they were the patient. For a child, that is usually a parent, with a few exceptions.

A person named in an adult’s health care power of attorney can often ask for records as their personal representative. After a death, the person who handles the estate can get the records needed for that job. Your state’s law decides who can act.

While the person is alive, a provider may share details with a family member who helps with care, unless the person says no.

After a death, a provider may also share some details with family who helped with the person’s care, limited to that care.

After a death, our wrongful death case page explains in general how those claims work.

Sources

  1. FDA: Cartiva implant safety and effectiveness summary (P150017)
  2. FDA recall Z-0598-2025: Cartiva implant
  3. AAOS OrthoInfo: Hallux rigidus (stiff big toe)
  4. eCFR: 42 CFR 482.51, hospital surgical services (operative reports)
  5. JPML transfer order, Cartiva MDL No. 3172 (Feb. 5, 2026)
  6. FDA: Cartiva implant approval record (P150017)FDA: Cartiva implant approval record (P150017) · regulator
  7. FDA: What is a medical device recall? (Cartiva capture)FDA: What is a medical device recall? (Cartiva capture) · regulator
  8. MedlinePlus: Talking with your doctorMedlinePlus: Talking with your doctor · regulator
  9. FDA: UDI basicsFDA: UDI basics · regulator
  10. FDA: Unique Device Identification SystemFDA: Unique Device Identification System · regulator
  11. FDA: MedWatch Form 3500 (device problem report)FDA: MedWatch Form 3500 (device problem report) · regulator
  12. E.D. Ark.: Cartiva MDL initial management order (Aug. 31, 2026)E.D. Ark.: Cartiva MDL initial management order (Aug. 31, 2026) · court
  13. NCI: Pathology reportsNCI: Pathology reports · regulator
  14. HHS: Your right to access your health informationHHS: Your right to access your health information · regulator
  15. Butler et al., Eur J Orthop Surg Traumatol (2024): systematic reviewButler et al., Eur J Orthop Surg Traumatol (2024): systematic review · study
  16. Glazebrook et al., Foot & Ankle Specialist (2025): fusion after a failed implantGlazebrook et al., Foot & Ankle Specialist (2025): fusion after a failed implant · study
  17. HHS: Personal representatives under HIPAAHHS: Personal representatives under HIPAA · regulator
  18. eCFR: 45 CFR 164.502(g), personal representativeseCFR: 45 CFR 164.502(g), personal representatives · regulator
  19. HHS: Health information of deceased individualsHHS: Health information of deceased individuals · regulator
  20. eCFR: 45 CFR 164.510(b), sharing with family involved in careeCFR: 45 CFR 164.510(b), sharing with family involved in care · regulator

Checked against 20 primary sources by People's Justice editors · Updated

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