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

Catalog Number	CAR-08-US
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
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.

• 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: 25446812
• Report Number: 3010667733-2026-00774
• Device Sequence Number: 9557185
• Product Code: PNW
• UDI-Device Identifier: 00852897002021
• UDI-Public: (01)00852897002021(17)210430(10)F040419001
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P150017
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: 04/30/2021
• Device Catalogue Number: CAR-08-US
• Device Lot Number: F040419001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2019
• 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