MAUDE Adverse Event Report: Cartiva, INC CARTIVA IMPLANT 10MM; Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

Catalog Number	CAR-10-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs.No additional information is available due to ongoing litigation.If additional information becomes available, a supplemental report will be submitted.

• Brand Name: CARTIVA IMPLANT 10MM
• 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: 50346068
• Report Number: 3009351194-2026-00037
• Device Sequence Number: 10146635
• Product Code: PNW
• UDI-Device Identifier: 00852897002038
• UDI-Public: 00852897002038
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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 Catalogue Number: CAR-10-US
• Device Lot Number: F120618001
• 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: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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