MAUDE Adverse Event Report: CARTIVA, INC CARTIVA IMPLANT 12MM; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Catalog Number	CAR-12-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Discomfort (2330); Implant Pain (4561)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was alleged by a claimant, through counsel, that he was implanted with cartiva on the right side on (b)(6) 2022 and was revised on (b)(6) 2022 due to hallux rigidus with painful cartiva implant great toe right foot.Claimant demands compensation.
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.The device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.

• Brand Name: CARTIVA IMPLANT 12MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21036661
• Report Number: 3009351194-2024-00131
• Device Sequence Number: 7656466
• Product Code: PNW
• UDI-Device Identifier: 00852897002335
• UDI-Public: 00852897002335
• 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: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2024

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-12-US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 12/30/2024
• 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: Male