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

Model Number AGILI-C 12.5MM

Device Problem Failure to Osseointegrate (1863)

Patient Problem Arthralgia (2355)

Event Date 11/03/2022

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 304716248
• Report Number: 3013881076-2022-00001
• Device Sequence Number: 1
• Product Code: QRU
• UDI-Device Identifier: 07290019087021
• UDI-Public: 07290019087021
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

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: 05/21/2021
• 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
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White