Truliant 02-020-13-0325Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862315311), received between Feb 2, 2022 and Nov 9, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 58 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED. REASON FOR THE REVISION WAS NOT REPORTED. DEVICES ARE NOT RETURNING.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15761693 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6) STUDY, APPROXIMATELY THREE MONTHS POST RIGHT TKA, PATIENT HAS INCREASED PAIN AND SWELLING WHEN BENDING KNEE. A JOINT ASPIRATION DONE, SYNOVIAL FLUID ANALYSIS WAS PERFORMED AND LABS SHOW POSITIVE FOR PERSISTENT INFECTION (CONTINUED CHRONIC PROSTHETIC JOINT INFECTION). SURGEON PERFORMED A REVISION SURGERY ON (B)(6) 2021 WITH REMOVAL OF IMPLANTS, PLACEMENT OF SPACER, AND IMPLANTED REMEDY MANUFACTURER COMPONENTS. PATIENT HAS BEEN STARTED ON 6-WEEKS IV ANTIBIOTICS. THE EVENT IS UNLIKELY RELATED TO THE DEVICE BUT RELATED TO THE PROCEDURE.

  Patient problems: Bacterial Infection

  MAUDE report 13426437 ↗