Agili-C CH-125Recalls & reported problems
Cartiheal (2009) Ltd · Agili-C Implant Diameter 12.5mm, Length 10mm · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290019087021), received between Dec 2, 2022 and Jan 5, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Failure to Osseointegrate1
Patient problems
- Arthralgia2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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).
Patient problems: Arthralgia
MAUDE report 18456295 ↗InjuryDec 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
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.
Patient problems: Arthralgia
MAUDE report 15906302 ↗
Other Implant, Resorbable, For Articular Osteochondral Repair devices
- Agili-C CHP0752Cartiheal (2009) Ltd · Implant, Resorbable, For Articular Osteochondral Repair3 reports
- Agili-C CHP0755Cartiheal (2009) Ltd · Implant, Resorbable, For Articular Osteochondral Repair1 report
- Agili-C CHP0753Cartiheal (2009) Ltd · Implant, Resorbable, For Articular Osteochondral Repair1 report
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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