MAUDE Adverse Event Report: CARTIHEAL LTD., AGILI-C

Model Number	AGILI-C 12.5MM
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject (b)(4), as part of a clinical study was implanted with 2 agili-c implants on (b)(6) 2018.An arthroscopy was performed on (b)(6) 2022, following several months of knee pain which did not resolve with conservative treatment.During the procedure, one of the agili-c implants was extracted due to lack of implant integration and cyst formation.The bone cyst was filled and impacted with allograft bone chips with bmca.Concomitantly, the subject underwent medial meniscectomy due to an unrelated degenerative meniscal tear.
Additional Manufacturer Narrative
Analysis of production records found no issues associated with the lot or serial number.Lack of implant integration and bone cysts are known adverse events, as documented in the agili-c ifu and risk analysis.
Additional Manufacturer Narrative
Analysis of production records found no issues associated with the lot or serial number.Lack of implant integration and bone cysts are known adverse events, as documented in the agili-c ifu and risk analysis.
Event or Problem Description
Subject (b)(6), as part of a clinical study was implanted with 2 agili-c implants on (b)(6) 2018.An arthroscopy was performed on (b)(6) 2022, following several months of knee pain which did not resolve with conservative treatment.During the procedure, one of the agili-c implants was extracted due to lack of implant integration and cyst formation.The bone cyst was filled and impacted with allograft bone chips with bmca.Concomitantly, the subject underwent medial meniscectomy due to an unrelated degenerative meniscal tear.Following the subjects visit on (b)(6)2023, it was reported that the event was closed as the subject recovered.No additional information is expected.Final report.

• Brand Name: AGILI-C
• Common Device Name: AGILI-C
• Manufacturer (Section D): CARTIHEAL LTD.,; 17 atir yeda st.; kfar saba, 44643 13; IS 4464313
• Manufacturer (Section G): CARTIHEAL LTD.,; 17 atir yeda st.; kfar saba, 44643 13; IS 4464313
• Manufacturer Contact: adam waksman ; 17 atir yeda st.; kfar saba,, NJ 44643-13 ; IS 4464313 ; 2017259663
• MDR Report Key: 15906302
• Report Number: 3013881076-2022-00001
• Device Sequence Number: 5162004
• Product Code: QRU
• UDI-Device Identifier: 07290019087021
• UDI-Public: 07290019087021
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P210034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 05/21/2021
• Device Model Number: AGILI-C 12.5MM
• Device Catalogue Number: CH-125
• Device Lot Number: 127
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• 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: Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White