Truliant 02-020-12-0225Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862314772), received between Jan 14, 2022 and Jan 14, 2022 — classified as 1 injury.

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.

• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A (B)(6), FEMALE PATIENT HAD A REVISION DUE TO INSTABILITY OF THE KNEE. THIS IS A WELL FIXATED POROUS FEMUR AND TIBIA LESS THAN A YEAR OLD. SURGEON REMOVED THE FEMORAL AND TIBIAL POROUS COMPONENTS. PATIENT REVISED TO A SIZE 2 CONDYLAR CONSTRAINED FEMUR AND HE SIZE 2F/1T TRULIANT TIBIAL FIT TRAY WITH A 15 MM CONDYLAR CONSTRAINED INSERT. THERE WAS NO BREAKAGE TO THE DEVICE. THERE WAS NO SURGICAL DELAY/ PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 13260560 ↗