MAUDE Adverse Event Report: CARTIHEAL LTD. AGILI-C

Model Number AGILI-C 7.5MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthralgia (2355)

Event Date 10/03/2023

Event Type  Injury  

Event Description

Subject (b)(6), as part of a clinical study was implanted with 1 agili-c implant in the lateral femoral condyle on (b)(6) 2018.On (b)(6) 2023, the subject underwent total knee replacement of the left knee (index knee) due to continued antero-medial knee pain which did not respond to conservative treatment, radio frequency ablation or ha injections.The event was assessed as "unlikely related (to study device and/or tool-set or to study procedure)" by the treating physician (investigator).

• Brand Name: AGILI-C
• Type of Device: AGILI-C
• Manufacturer (Section D): CARTIHEAL LTD.; 17 atir yeda; kfar saba, 44643 13; IS 4464313
• Manufacturer (Section G): CARTIHEAL; 17 atir yeda; kfar saba, 44643 13; IS 4464313
• Manufacturer Contact: adam waksman ; 3 reuten dr.; closter, NJ 07624
• MDR Report Key: 18456295
• MDR Text Key: 332256066
• Report Number: 3013881076-2024-00001
• Device Sequence Number: 1
• Product Code: QRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/04/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: AGILI-C 7.5MM
• Device Catalogue Number: CH-125
• Device Lot Number: 125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White