MAUDE Adverse Event Report: CARTIVA, INC CARTIVA IMPLANT 10MM; PROSTHESIS, TOE, HEMI-, PHALANGEAL

Catalog Number	CAR-10-US
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
Correction: d2a (common device name), d2b (product code), h6 (method).The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: CARTIVA IMPLANT 10MM
• Common Device Name: PROSTHESIS, TOE, HEMI-, PHALANGEAL
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23220866
• Report Number: 3009351194-2025-00200
• Device Sequence Number: 9458715
• Product Code: KWD
• UDI-Device Identifier: 00852897002038
• UDI-Public: (01)00852897002038(11)170530(17)190531(10)F051117001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: CAR-10-US
• Device Lot Number: F051117001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female