MAUDE Adverse Event Report: CARTIHEAL AGILI-C

Model Number	AGILI-C 7.5MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arthralgia (2355); Joint effusion (4849)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a 37 y/o male was implanted with 2 agili-c implants in the mfc.Concomitantly, the patient underwent both acl reconstruction and a meniscal repair.On september 17, 2024, the manufacture was notified that the patient was experiencing pain, swelling, and difficulty with daily activities, which may require revision surgery.On december 23, 2024, it was reported that the patient underwent revision surgery on (b)(6) 2024.The 2 agili-c implants were replaced with two osteochondral allografts (oca) in a snowman technique.In addition, the patient underwent a concomitant meniscectomy.
Additional Manufacturer Narrative
Initial report.
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.Efforts were made to obtain further relevant details regarding the event; however, these attempts were unsuccessful, and no additional information could be retrieved.Given the limited data available for analysis, it was not possible to definitively determine the root cause of the reported event; however, should additional information be available in the future, we will re-open the investigation and submit a supplemental report.
Event or Problem Description
On (b)(6) 2023, a 37 y/o male was implanted with 2 agili-c implants in the mfc, at the (b)(6) center.Concomitantly, the patient underwent both acl reconstruction and a meniscal repair.On (b)(6) 2024, the manufacture was notified that the patient was experiencing pain, swelling, and difficulty with daily activities, which may require revision surgery.On (b)(6) 2024, it was reported that the patient underwent revision surgery on (b)(6) 2024.The 2 agili-c implants were replaced with two osteochondral allografts (oca) in a snowman technique.In addition, the patient underwent a concomitant meniscectomy.

• Brand Name: AGILI-C
• Common Device Name: AGILI-C
• Manufacturer (Section D): CARTIHEAL; 17 atir yeda; kfar saba, 44643 13; IS 4464313
• Manufacturer (Section G): CARTIHEAL LTD.; 17 atir yeda st.; kfar saba, NV 44643 13; IS 4464313
• Manufacturer Contact: adam waksman ; 17 atir yeda st.; kfar saba,, NV 44643-13 ; IS 4464313 ; 7027236889
• MDR Report Key: 21204131
• Report Number: 3013881076-2025-00001
• Device Sequence Number: 8080791
• Product Code: QRU
• UDI-Device Identifier: 07290019087168
• UDI-Public: 07290019087168
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P210034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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: CH-075
• Device Lot Number: 144
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2023
• 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; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Male