Cartiva Synthetic Cartilage Implant CAR-10-USRecalls & reported problems
Cartiva, Inc · 10 mm Synthetic Cartilage Implant · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Cartiva synthetic cartilage implant replaces cartilage in the toe joint. Many of the 136 reports describe pain, discomfort and reduced joint movement, and some describe repeat surgery or removal. There are no deaths and 136 injuries, and reports fell from 103 in the previous 12 months to 12 in the latest 12 months. There is 1 open recall, started in October 2024, about higher-than-expected rates of repeat surgery, removal, sinking, displacement, pain, nerve damage or fragmentation.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 139
- Deaths reported
- 0
- Injuries reported
- 139
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 00852897002038), received between Feb 28, 2017 and Aug 20, 2026 — classified as 139 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (15 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Oct 31, 2024Class IIOpen, Classified
Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation.
Z-0598-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem92
- Osseointegration Problem15
- Implant subsidence12
- Migration11
- Insufficient Device Problem Information8
- Material Fragmentation3
- Degraded2
- Delivered as Unsterile Product2
Patient problems
- Pain66
- Discomfort29
- Implant Pain28
- Loss of Range of Motion20
- Arthritis14
- Inadequate Osseointegration14
- Insufficient Information11
- Failure of Implant10
Recent adverse event reports
The 25 most recent of 139 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient, through counsel, alleged implantation of a Cartiva device on the left side. The patient subsequently underwent a revision procedure due to alleged hallux rigidus and pain.
Patient problems: Arthritis; Pain
MAUDE report 50346068 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
Patient, through counsel, alleges that they were implanted with Cartiva on the left side and underwent revision for reasons currently unknown.
Patient problems: Insufficient Information
MAUDE report 50344899 ↗InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
As reported: "Patient, through counsel, alleges that she was implanted with Cartiva on the right side on (b)(6)2018 and underwent revision on (b)(6)2019."
Patient problems: Insufficient Information
MAUDE report 50334044 ↗InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
As reported: "Patient, through counsel, alleges that she was implanted with Cartiva on the right side on (b)(6)2017. Patient underwent revision on (b)(6)2025 due to alleged pain."
Patient problems: Pain
MAUDE report 50334041 ↗InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
Patient, through counsel, alleges that he was implanted with Cartiva on the left side on (b)(6)2019. Patient underwent revision on (b)(6)2023 due to alleged hallux rigidus.
Patient problems: Arthritis
MAUDE report 50331259 ↗InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
Patient, through counsel, alleges that he was implanted with Cartiva on the left side on (b)(6)2020. Patient underwent revision on (b)(6)2025 due to alleged pain.
Patient problems: Pain
MAUDE report 50330740 ↗InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
Patient, through counsel, alleges that she was implanted with Cartiva on the right side on (b)(6)2017. Patient underwent revision on (b)(6)2025 due to alleged pain.
Patient problems: Pain
MAUDE report 50330738 ↗InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem
Patient, through counsel, alleges that he was implanted with Cartiva on the right side on (b)(6)2018. Patient underwent revision on (b)(6)2025 due to alleged pain.
Patient problems: Pain
MAUDE report 50257006 ↗InjuryJun 9, 2026Insufficient Device Problem Information
Claimant, through counsel, alleges that she was implanted with Cartiva on the left side on (b)(6)2018 and revised on (b)(6)2019 due to unspecified product failure.
Patient problems: Insufficient Information
MAUDE report 25446811 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT HAD A CARTIVA IMPLANT PLACED IN HER RIGHT FIRST MTP JOINT.CLAIMANT, THROUGH COUNSEL, ALLEGES THAT SHE SUBSEQUENTLY UNDERWENT REMOVAL OF THE CARTIVA IMPLANT WITH ARTHRODESIS OF THE RIGHT GREAT TOE DUE TO PAIN AND STIFFNESS, IN ADDITION TO A BUNIONECTOMY AND SECOND THROUGH FOURTH HAMMERTOE CORRECTION.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 24421518 ↗InjuryFeb 23, 2026Material Fragmentation
CLAIMANT, THROUGH COUNSEL, ALLEGES THAT SHE WAS IMPLANTED WITH CARTIVA IN HER RIGHT FIRST MTP JOINT ON (B)(6) 2018, AND UNDERWENT IRRIGATION AND DEBRIDEMENT ON (B)(6) 2018, DUE TO ERYTHEMA AND SOME WOUND DEHISCENCE. THE PRE AND POSTOPERATIVE DIAGNOSIS WAS "RIGHT HALLUX METATARSOPHALANGEAL JOINT SURGICAL SITE INFECTION STATUS POST CARTIVA IMPLANTATION" AND DURING THIS PROCEDURE "AS SOON AS WE GOT ACCESS TO THE JOINT, WE CAME ACROSS A SMALL 3 MM DELAMINATED PIECE OF THE CARTIVA IMPLANT" WHICH WAS REMOVED. THE IMPLANT WAS CHECKED AND NOTED NOT LOOSE AND WAS LEFT IN.
Patient problems: Erythema; Post Operative Wound Infection; Wound Dehiscence
MAUDE report 24420571 ↗InjuryFeb 13, 2026Implant subsidence
THE CLAIMANT ALLEGES CARTIVA SCI IMPLANTED ON (B)(6) 2020, REQUIRED REVISION SURGERY ON (B)(6) 2025 DUE TO SUBSIDENCE.
Patient problems: Insufficient Information
MAUDE report 24335296 ↗InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLAIMANT, THROUGH COUNSEL, ALLEGES THAT SHE WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE ON (B)(6) 2017 AND UNDERWENT REVISION SURGERY ON (B)(6) 2018 DUE TO PAIN.
Patient problems: Pain
MAUDE report 23790751 ↗InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLAIMANT ALLEGES IMPLANTATION WITH CARTIVA ON THE LEFT SIDE AND SUBSEQUENT REVISION DUE TO HALLUX RIGIDUS.
Patient problems: Arthritis
MAUDE report 23771839 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLAIMANT, THROUGH COUNSEL, ALLEGES THAT HE WAS IMPLANTED WITH CARTIVA IN THE RIGHT SIDE ON (B)(6) 2021 AND REVISED ON (B)(6) 2023 DUE TO HALLUS RIGIDUS.
Patient problems: Arthritis
MAUDE report 23351377 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLAIMANT, THROUGH COUNSEL, ALLEGES THAT THE PATIENT WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE ON (B)(6) 2018 AND REVISED ON (B)(6) 2018 DUE TO PAIN.
Patient problems: Pain
MAUDE report 23347969 ↗InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "CLAIMANT, THROUGH COUNSEL, ALLEGES THAT HE WAS IMPLANTED WITH CARTIVA IN THE LEFT SIDE ON (B)(6) 2021 AND REVISED ON 1/19/2023 DUE TO PAIN AND HALLUS RIGIDUS".
Patient problems: Arthritis; Pain
MAUDE report 23343291 ↗InjuryOct 20, 2025Migration; Migration
PATIENT WAS IMPLANTED WITH CARTIVA ON THE LEFT AND REVISED DUE TO HALLUX RIGIDUS AND SUBSIDENCE.
Patient problems: Pain
MAUDE report 23343153 ↗InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "CLAIMANT, THROUGH COUNSEL, ALLEGES THAT SHE WAS IMPLANTED WITH CARTIVA IN THE RIGHT SIDE ON (B)(6) 2018 AND REVISED ON (B)(6) 2024 DUE TO PAIN".
Patient problems: Pain
MAUDE report 23343150 ↗InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS IMPLANTED WITH CARTIVA ON THE LEFT SIDE AND WAS REVISED DUE TO HALLUX RIGIDUS AND PAIN.
Patient problems: Arthritis; Pain
MAUDE report 23343145 ↗InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS IMPLANTED WITH CARTIVA ON LEFT SIDE AND REVISED DUE TO HALLUS RIDIGUS AND PAIN.
Patient problems: Pain
MAUDE report 23343144 ↗InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLAIMANT, THROUGH COUNSEL, ALLEGES THAT HE WAS IMPLANTED WITH CARTIVA IN THE RIGHT FOOT ON (B)(6) 2019 AND REVISED ON (B)(6) 2020 DUE TO HALLUX RIGIDUS AND PAIN.
Patient problems: Arthritis; Pain
MAUDE report 23342895 ↗InjuryOct 6, 2025Implant subsidence; Implant subsidence
IT WAS REPORTED BY PATIENT'S COUNSEL THAT ALLEGEDLY ON (B)(6) 2018, THE PATIENT UNDERWENT RIGHT FIRST METATARSOPHALANGEAL CHEILECTOMY, DEBRIDEMENT AND CAPSULAR RELEASE AND WAS IMPLANTED WITH A 10MM CARTIVA IMPLANT.
Patient problems: Pain
MAUDE report 23220866 ↗InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY PATIENT'S COUNSEL THAT ALLEGEDLY ON (B)(6) 2020, THE PATIENT UNDERWENT RIGHT FIRST METATARSOPHALANGEAL CHEILECTOMY AND IMPLANT ARTHROPLASTY AND WAS IMPLANTED WITH A 10MM CARTIVA IMPLANT. SHE SUBSEQUENTLY WAS REVISED ON (B)(6) 2024, DUE TO ALLEGED PAIN AND NUMBNESS IN HER TOE WHICH WAS CAUSING HER TO LOSE BALANCE.
Patient problems: Numbness; Pain
MAUDE report 22732059 ↗
Other Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant devices
- Cartiva Synthetic Cartilage Implant CAR-08-USCartiva, Inc · Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant1 recall41 reports
- Cartiva Synthetic Cartilage Implant CAR-12-USCartiva, Inc · Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant1 recall4 reports
- Cartiva Synthetic Cartilage Implant CAR-06-USCartiva, Inc · Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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