Cartiva Synthetic Cartilage Implant CAR-08-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00852897002021), received between Jan 3, 2018 and Aug 19, 2026 — classified as 41 injuries.

The most frequently reported specific device problem is “Implant subsidence” (6 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.

Recalls naming this device

1. 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

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• 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. Patient underwent revision on (b)(6) 2022 due to alleged pain."

  Patient problems: Pain

  MAUDE report 50334028 ↗
• 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 25446812 ↗
• InjuryFeb 23, 2026Implant subsidence

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT HAD A CARTIVA IMPLANT PLACED IN HER LEFT FIRST MTP JOINT. CLAIMANT, THROUGH COUNSEL, ALLEGES THAT THE IMPLANT WAS SUBSEQUENTLY SURGICALLY REMOVED DUE TO PAIN AND SUBSIDENCE.

  Patient problems: Pain

  MAUDE report 24421511 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  CLAIMANT, THROUGH COUNSEL, ALLEGES THAT HE WAS IMPLANTED WITH CARTIVA IN HIS LEFT FIRST MTP JOINT ON (B)(6) 2017 AND HAD TO HAVE THE IMPLANT SURGICALLY REMOVED ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 23950018 ↗
• InjuryOct 22, 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 ON THE LEFT SIDE ON (B)(6) 2017 AND REVISED ON (B)(6) 2018 DUE TO PAIN".

  Patient problems: Pain

  MAUDE report 23361051 ↗
• InjuryOct 8, 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)2018, THE PATIENT UNDERWENT BILATERAL BUNIONECTOMY AND BILATERAL CHEILECTOMY AND WAS IMPLANTED WITH 8 MM CARTIVA IMPLANTS. THE PATIENT SUBSEQUENTLY DEVELOPED SIGNIFICANT REDUCTION IN HER RANGE OF MOTION AS WELL AS PAIN TO THE JOINTS. THE PATIENT ALSO HAD SOME HALLUX ABDUCTOVALGUS DEFORMITY WHICH WAS FORMING TO BOTH GREAT TOE JOINTS. THE PATIENT UNDERWENT BILATERAL FIRST METATARSOPHALANGEAL JOINT ARTHROPLASTY ON (B)(6)2024.

  Patient problems: Deformity/ Disfigurement; Loss of Range of Motion; Pain

  MAUDE report 23246619 ↗
• InjuryOct 8, 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) 2018, THE PATIENT UNDERWENT BILATERAL BUNIONECTOMY AND BILATERAL CHEILECTOMY AND WAS IMPLANTED WITH 8 MM CARTIVA IMPLANTS. THE PATIENT SUBSEQUENTLY DEVELOPED SIGNIFICANT REDUCTION IN HER RANGE OF MOTION AS WELL AS PAIN TO THE JOINTS. THE PATIENT ALSO HAD SOME HALLUX ABDUCTOVALGUS DEFORMITY WHICH WAS FORMING TO BOTH GREAT TOE JOINTS. THE PATIENT UNDERWENT BILATERAL FIRST METATARSOPHALANGEAL JOINT ARTHROPLASTY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement; Loss of Range of Motion; Pain

  MAUDE report 23246618 ↗
• InjuryJul 8, 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 IN THE RIGHT 1ST MTP JOINT ON (B)(6) 2019. PATIENT HAS NOT BEEN REVISED BUT A MEDICAL PROVIDER HAS RECOMMENDED REVISION. PATIENT ALLEGES PAIN AND LIMITED MOBILITY DUE TO THE IMPLANT.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 22441312 ↗
• InjuryJul 7, 2025Implant subsidence; Implant subsidence

  CLAIMANT, THROUGH COUNSEL, ALLEGES IMPLANTATION OF A CARTIVA DEVICE IN THE RIGHT GREAT TOE. ALLEGED SYMPTOMS INCLUDE PERSISTENT PAIN, DISCOMFORT, SWELLING, AND IMAGING REPORTEDLY SHOWED IMPLANT RECESSION WITH RESULTING BONE-ON-BONE CONTACT IN THE TOE JOINT.

  Patient problems: Joint Impingement; Pain; Swelling/ Edema

  MAUDE report 22417679 ↗
• InjuryJun 30, 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) 2019 AND REVISED ON (B)(6) 2024 DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 22362308 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT UNDERWENT HALLUX RIGIDUS CORRECTION WITH CHEILECTOMY AND CARTIVA IMPLANT IN THE LEFT FIRST METATARSOPHALANGEAL JOINT. SHE SUBSEQUENTLY WAS REVISED DUE TO ALLEGED PAIN.

  Patient problems: Pain

  MAUDE report 22100893 ↗
• InjuryJan 13, 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 THE LEFT SIDE ON (B)(6) 2019. PATIENT ALLEGES HE WAS SCHEDULED FOR A REVISION ON THE RIGHT FOOT FOR (B)(6) 2024. PATIENT ALSO ALLEGES HIS SURGEON RECOMMENDED REVISION ON THE LEFT FOOT AS WELL. PATIENT CLAIMS ONGOING PAIN DUE TO THE IMPLANTS.

  Patient problems: Implant Pain

  MAUDE report 21136791 ↗
• InjuryJan 13, 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 THE LEFT SIDE ON (B)(6) 2019. PATIENT ALLEGES HE WAS SCHEDULED FOR A REVISION ON THE RIGHT FOOT FOR (B)(6) 2024. PATIENT ALSO ALLEGES HIS SURGEON RECOMMENDED REVISION ON THE LEFT FOOT AS WELL. PATIENT CLAIMS ONGOING PAIN DUE TO THE IMPLANTS.

  Patient problems: Implant Pain

  MAUDE report 21136790 ↗
• InjuryJan 13, 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 ON THE LEFT SIDE ON (B)(6)2019. PATIENT HAS NOT BEEN REVISED AND NO PROVIDER HAS RECOMMENDED A REVISION, HOWEVER, THE PATIENT ALLEGES PAIN.

  Patient problems: Implant Pain

  MAUDE report 21135543 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS ALLEGED BY CLAIMANT THROUGH COUNSEL, THAT HE WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE ON NO DATE GIVEN AND REVISED ON (B)(6) 2024 DUE TO HALLUX LIMITUS. CLAIMANT DEMANDS COMPENSATION.

  Patient problems: Arthritis

  MAUDE report 21124327 ↗
• InjuryJan 10, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS ALLEGED BY CLAIMANT THROUGH COUNSEL, THAT SHE WAS IMPLANTED WITH CARTIVA ON THE LEFT SIDE ON (B)(6) 2023 AND REVISED ON (B)(6) 2024 DUE TO SUBSIDENCE. CLAIMANT DEMANDS COMPENSATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21124208 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS ALLEGED BY CLAIMANT THROUGH COUNSEL, THAT SHE WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE ON (B)(6) 2018 AND REVISED ON (B)(6) 2022 DUE TO PAIN. CLAIMANT DEMANDS COMPENSATION.

  Patient problems: Pain

  MAUDE report 21109968 ↗
• InjuryJan 8, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS ALLEGED BY CLAIMANT THROUGH COUNSEL, THAT SHE WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE ON (B)(6) 2018 AND REVISED ON (B)(6) 2023 DUE TO PAIN AND SUBSIDENCE. CLAIMANT DEMANDS COMPENSATION.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21107710 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS ALLEGED BY CLAIMANT, THROUGH COUNSEL, THAT SHE WAS IMPLANTED WITH CARTIVA ON THE LEFT SIDE ON (B)(6) 2021. PATIENT HAS NOT BEEN REVISED BUT A MEDICAL PROVIDER HAS RECOMMENDED REVISION DUE TO AN UNSPECIFIED PRODUCT FAILURE. PATIENT DEMANDS COMPENSATION.

  Patient problems: Failure of Implant

  MAUDE report 21107655 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS ALLEGED BY CLAIMANT, THROUGH COUNSEL, THAT SHE WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE ON (B)(6) 2018. PATIENT HAS NOT BEEN REVISED AND HAS NOT BEEN RECOMMENDED FOR REVISION, YET CLAIMS DAMAGES DUE TO PAIN. PATIENT DEMANDS COMPENSATION.

  Patient problems: Discomfort; Pain

  MAUDE report 21107584 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS ALLEGED BY CLAIMANT, THROUGH COUNSEL, THAT SHE WAS IMPLANTED WITH CARTIVA ON THE LEFT SIDE ON (B)(6) 2020. PATIENT HAS NOT BEEN REVISED BUT A MEDICAL PROVIDER HAS RECOMMENDED REVISION. PATIENT ALLEGES PAIN AND A COMPLETE LOSS OF MOBILITY IN HER TOE DUE TO THE IMPLANT. PATIENT DEMANDS COMPENSATION.

  Patient problems: Discomfort; Implant Pain; Loss of Range of Motion

  MAUDE report 21107581 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS ALLEGED BY CLAIMANT, THROUGH COUNSEL, THAT SHE WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE ON (B)(6) 2018. PATIENT HAS NOT BEEN REVISED, YET CLAIMS THAT SHE WAS INDICATED FOR A REVISION SURGERY DUE TO PAIN, A SHORTENED TOE, AND A LACK OF MOBILITY. PATIENT DEMANDS COMPENSATION.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Physical Asymmetry

  MAUDE report 21107574 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS ALLEGED BY CLAIMANT, THROUGH COUNSEL,THAT SHE WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE ON (B)(6) 2023 AND REVISED ON 12/18/2023 DUE TO UNSPECIFIED PRODUCT FAILURE. CLAIMANT DEMANDS COMPENSATION.

  Patient problems: Failure of Implant

  MAUDE report 21107389 ↗
• InjuryJan 8, 2025Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence

  IT WAS ALLEGED BY CLAIMANT, THROUGH COUNSEL, THAT SHE WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE ON (B)(6) 2019 AND REVISED ON (B)(6) 2024 DUE TO PAIN, A LOOSE CARTIVA IMPLANT, AND SUBSIDENCE. CLAIMANT DEMANDS COMPENSATION.

  Patient problems: Discomfort; Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 21107384 ↗
• InjuryJan 8, 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 ON THE LEFT SIDE ON (B)(6) 2018 AND REVISED ON (B)(6) 2022 DUE TO PAIN.

  Patient problems: Implant Pain

  MAUDE report 21100517 ↗