Agili-C CHP0755Recalls & reported problems

Cartiheal (2009) Ltd · 5X Agili-C D7.5 Implant · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290019087182), received between Sep 19, 2024 and Sep 19, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

Joint effusion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PATIENT WAS TREATED AT (B)(6) 2024 WITH FIVE AGILI-C 7.5MM IMPLANTS. 4 IMPLANTS IN THE TROCHLEA AND 1 IMPLANT IN THE MFC (MEDIAL FEMORAL CONDYLE). POST-OP KNEE X-RAYS INDICATED THAT MFC IMPLANT WAS PROTRUDING AND NOT FULLY RECESSED BELOW THE ARTICULAR CARTILAGE TO THE LEVEL OF THE SUBCHONDRAL BONE AS INSTRUCTED BY THE IFU. ON (B)(6) 2024, THE PATIENT UNDERWENT ARTHROSCOPY DUE TO POST-OPERATIVE RECURRING EFFUSION OF THE KNEE. THE MFC IMPLANT WAS REMOVED DUE TO IMPLANT LOOSENING. NO ADDITIONAL INFORMATION IS EXPECTED. FINAL REPORT.
Patient problems: Joint effusion
MAUDE report 20260989 ↗

Device details

UDI-DI	`07290019087182`
Brand	Agili-C
Model	CHP0755
Company	Cartiheal (2009) Ltd
Product code	QRU · Implant, Resorbable, For Articular Osteochondral Repair
Class	Class 3
FDA submission	P210034
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Jun 8, 2023

Device type (GMDN): Osteochondral matrix implant

A sterile bioabsorbable device designed to be implanted to fill osteochondral defects. It is a porous and multilayered device, one layer of synthetic bone substitute material (e.g. ceramics such as tricalcium phosphate or hydroxyapatite) combined with a biological material (e.g., bovine collagen) intended to provide an osteoconductive bone tissue scaffold, and a second layer of predominantly biological material (e.g., bovine collagen) intended to provide a matrix structure that promotes the ingrowth of autologous cells for cartilage regeneration. Instruments to prepare the defect site and insert the implant may be included.

Other Implant, Resorbable, For Articular Osteochondral Repair devices

Agili-C CHP0752
Cartiheal (2009) Ltd · Implant, Resorbable, For Articular Osteochondral Repair
3 reports
Agili-C CH-125
Cartiheal (2009) Ltd · Implant, Resorbable, For Articular Osteochondral Repair
2 reports
Agili-C CHP0753
Cartiheal (2009) Ltd · Implant, Resorbable, For Articular Osteochondral Repair
1 report

All Implant, Resorbable, For Articular Osteochondral Repair devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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