Agili-C CHP0753Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290019087175), received between Jan 15, 2026 and Jan 15, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJan 15, 2026Fracture

  IT WAS REPORTED THAT, AFTER A CARTILAGE REPAIR SURGERY HAD BEEN CONDUCTED ON (B)(6) 2025 WITH THREE (3) 7.5 MM X 10 MM AGILI-C IMPLANTS ON AN UNSPECIFIED ANATOMICAL LOCATION, THE PATIENT STARTED EXPERIENCING PAIN AND SWELLING AROUND FOUR (4) MONTHS POST-OPERATIVELY. THE SURGEON NOTICED THAT THE MOST POSTERIOR IMPLANT WAS LEFT PROUD. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2025 TO REPLACE SUCH IMPLANT WITH A 10 MM X 10 MM AGILI-C IMPLANT. PART OF THE IMPLANT HAD BROKEN OFF AND WAS FLOATING AROUND IN THE JOINT; IT WAS REMOVED WITH AN ARTHROSCOPIC GRASPER. THE SITE OF THE REVISION WAS PREPARED WITH NORMAL AGILI-C TECHNIQUE FOR A 10MM IMPLANT. THE PATIENT HAS PRESENTED POSITIVE IMPROVEMENTS THUS FAR.

  Patient problems: Arthralgia; Swelling/ Edema

  MAUDE report 24079824 ↗