Truliant 02-020-13-0340Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862314697), received between Jul 30, 2025 and Jul 30, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 28 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, A FEMALE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS A SMALL NONDISPLACED DISTAL FEMUR FRACTURE ON THE MEDIAL SIDE. PATIENT CLAIMS THAT SHE FELL BECAUSE HER KNEE WAS UNSTABLE "BECAUSE OF THE RECALL". OPERATIVE FINDINGS INDICATED THE TOTAL KNEE COMPONENTS WERE WELL-FIXED, AND THE POLY INSERT WAS REMOVED. THERE WERE NO SIGNS OF WEAR ON THE POLY, AND IT HAD NO NOTICEABLE OXIDATION OR DELAMINATION. A NEW SIZE 4, 12MM POLY WAS INSERTED AND IMPLANTED. A COMPETITOR'S RETROGRADE NAIL WAS USED TO REPAIR THE FRACTURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES OF THE LINER AND X-RAYS WERE RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO THE POLY BEING KEPT AFTER SURGERY CONCLUDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Implant Pain; Joint Laxity; Loss of Range of Motion

  MAUDE report 22666404 ↗