MAUDE Adverse Event Report: Cartiva, INC CARTIVA IMPLANT 8MM; Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

Catalog Number	CAR-08-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
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.".
Additional Manufacturer Narrative
The reported event could not be confirmed because the device was not returned for evaluation, and no other evidence was provided.A review of the device history record for the reported lot did not identify any abnormalities.No corrective actions are currently required.A review of the labeling did not identify any abnormalities.No indications of material, manufacturing, or design-related problems were identified during the investigation.More detailed information about the complaint event, as well as the affected device, must be available to determine the root cause of the complaint event.If the device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: CARTIVA IMPLANT 8MM
• Common Device Name: Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
• 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 ; +1(201)831-5000
• MDR Report Key: 50334028
• Report Number: 3009351194-2026-00031
• Device Sequence Number: 5508719
• Product Code: PNW
• UDI-Device Identifier: 00852897002021
• UDI-Public: 00852897002021
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Type of Report: Initial
• Report Date (Section B): 08/19/2026

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: 08/31/2019
• Device Catalogue Number: CAR-08-US
• Device Lot Number: F072017002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2017
• 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 Sex: Female