Was Your Cartiva Implant Taken Out? The Records to Ask For

What surgery follows a failed Cartiva implant?

A surgeon may put in a new implant, or take the implant out and fuse the joint so the bones heal as one. In one surgeon’s 219 Cartiva surgeries, 8.2% of first implants needed another operation. That came about a year later on average.

Of the 23 repeat operations in that study, 11 were fusions and 12 used a new implant. Some new implants needed bone graft or a custom base to stop sinking. Fusion eased pain more than a new implant did.

A failed big-toe implant often leaves a large gap in the bone, which can make the next surgery harder. Bone graft may be needed to fill it. A first-time fusion does not usually need graft.

Talk to your surgeon before you make any choice about your implant.

What can X-ray and MRI reports show?

Studies of painful Cartiva implants describe what scans may show. The hole around the implant may grow wider, and the bone may wear away. Fluid around the implant may mean it is loose. Ask your doctor what your own scan report means.

In a Cedars-Sinai study of 18 painful implants, MRI showed the implant was smaller than the hole it sat in. Fluid around the implant was seen in 14 of them. Six of the 16 patients went on to have another surgery.

A German study compared 18 implant patients with 18 fusion patients. X-rays of the implant group often showed a wider implant hole or worn bone. Fusion patients had less pain when active.

These studies are small and describe groups of patients. They cannot tell you why your own implant failed.

Which papers show what happened to my Cartiva implant?

Ask for the surgeon’s notes from each operation, the implant sticker, and your X-rays, MRI and their reports. If tissue or the implant was sent to a lab, ask for that report too. Your right to copies covers X-rays and other images.

The surgery notes from the later operation should say what was found and what was done. They may say whether bone graft was used. In one study of big-toe fusions, researchers found graft use by reading surgery notes and X-rays.

Most device labels carry a device code, which the recall list uses for each size. Also write down the dates of each surgery and when you were told the implant had failed.

How fast must a provider send my records, and can I fix a mistake?

A provider must act on your request within 30 days. It may take up to 30 more days once, if it tells you why in writing. You can ask for the format you want, such as an email copy.

If something in your record is wrong, you can ask the provider to correct it. It must act within 60 days, with one more 30-day extension allowed. It can say no if it decides the record is already accurate and complete.

What happens to a Cartiva implant after it is taken out?

We found no court order yet on how removed implants must be kept. It is the first of six issues the judge asked both sides to work on. A status hearing by phone is set for October 8, 2026.

The two sides had to send the judge updated views on this by October 1, 2026. We could not read those papers, and we found no order on it as of October 5. If your surgery is already planned, ask your surgeon what will happen to the implant.

FDA’s 2016 approval required a follow-up study of the first trial’s patients. One goal was to check wear on any study implant that was removed. FDA says a problem report alone does not show the device caused the problem, and cause is even harder to show if no one examined the device.

You can report a problem with your implant to FDA through MedWatch. Your doctor does not have to do it for you. Patients can use a simpler form, called Form FDA 3500B.