Truliant 02-022-47-2513Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862306340), received between Nov 10, 2022 and Nov 10, 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.

• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA THE EXACTECH TRULIANT KNEE CLINICAL STUDY, THAT A 74 YO OBESE FEMALE PATIENT, WHO WAS INITIALLY IMPLANTED WITH A LEFT KNEE ON (B)(6) 2017, FOR THE PRIMARY INDICATION OF OSTEOARTHRITIS, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020, APPROXIMATELY 4 YEARS 10 MONTHS POST THE INITIAL IMPLANT PROCEDURE. DATE OF ONSET, (B)(6) 2020. THE STUDY INDICATES INFLAMMATION, DEFINITELY NOT RELATED TO DEVICES OR PROCEDURE. THE TIBIAL INSERT WAS REVISED, AND LABS SENT FROM LEFT KNEE FLUID. OUTCOME INDICATES RESOLVED ON (B)(6) 2020. NO ADDITIONAL INFORMATION.

  Patient problems: Inflammation; Pain

  MAUDE report 15769830 ↗