Agili-C CHP0752Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290019087168), received between Jan 21, 2025 and Jan 14, 2026 — classified as 3 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER AN INITIAL SURGERY THAT INCLUDED A CARTILAGE REPAIR WITH THREE (3) AGILI-C IMPLANTS, AN ACL RECONSTRUCTION WITH A QUAD AUTOGRAFT, A MENISCAL REPAIR, AND AN LET (LATERAL EXTRA-ARTICULAR TENODESIS) HAD BEEN PERFORMED ON (B)(6) 2025, IN WHICH THE PATIENT WAS IMPLANTED WITH TWO (2) AGILI-C PLUGS TO THE LATERAL FEMORAL CONDYLE AND ONE (1) TO THE TROCHLEA, THE PATIENT EXPERIENCED CONTINUED PAIN ON AN UNSPECIFIED DATE. THIS ADVERSE EVENT WAS ADDRESSED ON (B)(6) 2025 BY REVISING THE TWO (2) AGILI-C IMPLANTS IN THE LATERAL FEMORAL CONDYLE, USING OSTEOCHONDRAL ALLOGRAFT. THE SURGEON NOTICED THAT THERE WAS VERY LITTLE CARTILAGE GROWTH OVER THE AREA. CURRENTLY, THE PATIENT IS DOING WELL AND RECOVERING FROM THEIR SURGERY.

  Patient problems: Arthralgia; Cartilage damage; Pain

  MAUDE report 24073226 ↗
• InjuryAug 12, 2025Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2025, THE PATIENT, A 36-YEAR-OLD FEMALE, WAS IMPLANTED WITH 2 AGILI-C IMPLANTS IN THE MFC OF THE RIGHT KNEE. IN ADDITION, THE PATIENT UNDERWENT A CONCOMITANT MPFL AND AN OCA OF THE PATELLA AT THE TIME OF IMPLANTATION. THE PATIENT HAD REPORTEDLY BEEN DOING VERY WELL FOR THE FIRST 9-10 WEEKS POST IMPLANTATION AND THEN PRESENTED WITH PAIN AND SWELLING. NO ISSUES WERE REPORTED AT THE TIME OF IMPLANTATION AND NO KNOWN TRAUMA POST OPERATIVELY. ON (B)(6) 2025, CARTIHEAL WAS INFORMED THAT THE PATIENT UNDERWENT ARTHROSCOPIC EXPLORATION ON (B)(6) 2025. DURING THAT ARTHROSCOPIC LOOK, THE SURGEON FOUND LOOSE SOFT TISSUE FRAGMENTS AROUND THE IMPLANT, SO SHE PROCEEDED TO REMOVE/DEBRIDE THEM. THE SURGEON ALSO FOUND THAT THE IMPLANTS LOOKED LOOSE; WHEN SHE ATTEMPTED TO REMOVE THE IMPLANTS WITH A PITUITARY-TYPE INSTRUMENT, ONLY THE TOP HALF OF THE IMPLANTS CAME OFF. BASED ON HER SURGICAL EXPERTISE, SHE DECIDED TO LEAVE THE BOTTOM HALF OF THE IMPLANTS BECAUSE THEY DID NOT SEEM LOOSE. THE PATIENT IS DOING BETTER AND IS BEING MONITORED CLOSELY. NO FURTHER INTERVENTION IS PLANNED AT THIS TIME.

  Patient problems: Arthralgia

  MAUDE report 22781308 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2023, A 37 Y/O MALE WAS IMPLANTED WITH 2 AGILI-C IMPLANTS IN THE MFC, AT THE (B)(6) CENTER. CONCOMITANTLY, THE PATIENT UNDERWENT BOTH ACL RECONSTRUCTION AND A MENISCAL REPAIR. ON (B)(6) 2024, THE MANUFACTURE WAS NOTIFIED THAT THE PATIENT WAS EXPERIENCING PAIN, SWELLING, AND DIFFICULTY WITH DAILY ACTIVITIES, WHICH MAY REQUIRE REVISION SURGERY. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024. THE 2 AGILI-C IMPLANTS WERE REPLACED WITH TWO OSTEOCHONDRAL ALLOGRAFTS (OCA) IN A SNOWMAN TECHNIQUE. IN ADDITION, THE PATIENT UNDERWENT A CONCOMITANT MENISCECTOMY.

  Patient problems: Arthralgia; Joint effusion

  MAUDE report 21204131 ↗