MAUDE Adverse Event Report: CARTIHEAL LTD. AGILI-C

Model Number	AGILI-C 7.5MM
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records was conducted, and no evidence was found to suggest that the product deviated from its specifications at the time of manufacture.Following the evaluation of post-implantation mri images and intraoperative arthroscopic observations, the manufacturer has concluded that the agili-c implants were likely fractured during the postoperative period.This fracture appears to have resulted in loosening at the top of the implant, as evidenced during arthroscopy.It is suspected that the fracture may have led to the release of loose implant fragments into the joint cavity.These fragments could have triggered intra-articular irritation, thereby contributing to the development of knee swelling and pain.Implant fracture is a known adverse event and documented in the ifu and in the agili-c risk analysis.
Event or Problem Description
On (b)(6) 2025, the patient, a 36-year-old female, was implanted with 2 agili-c implants in the mfc of the right knee.In addition, the patient underwent a concomitant mpfl and an oca of the patella at the time of implantation.The patient had reportedly been doing very well for the first 9-10 weeks post implantation and then presented with pain and swelling.No issues were reported at the time of implantation and no known trauma post operatively.On (b)(6) 2025, cartiheal was informed that the patient underwent arthroscopic exploration on (b)(6) 2025.During that arthroscopic look, the surgeon found loose soft tissue fragments around the implant, so she proceeded to remove/debride them.The surgeon also found that the implants looked loose; when she attempted to remove the implants with a pituitary-type instrument, only the top half of the implants came off.Based on her surgical expertise, she decided to leave the bottom half of the implants because they did not seem loose.The patient is doing better and is being monitored closely.No further intervention is planned at this time.

• Brand Name: AGILI-C
• Common Device Name: AGILI-C
• Manufacturer (Section D): CARTIHEAL LTD.; kfar saba, ; IS
• Manufacturer (Section G): CARTIHEAL LTD.; 17 atir yeda st; kfar saba, il 44643 13; IS 4464313
• Manufacturer Contact: adam waksman ; 17 atir yeda st.; il; kfar saba, 44643-13 ; IS 4464313
• MDR Report Key: 22781308
• Report Number: 3013881076-2025-00003
• Device Sequence Number: 20869205
• Product Code: QRU
• UDI-Device Identifier: 07290019087168
• UDI-Public: 010729001908716810161
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P210034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: Health Professional
• Device Model Number: AGILI-C 7.5MM
• Device Catalogue Number: CHP075
• Device Lot Number: 161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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: 36 YR
• Patient Sex: Female