Truliant 02-022-45-5040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862305930), received between Feb 22, 2021 and Feb 22, 2021 — 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.

• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, DURING THE IMPLANTATION OF THE LEFT TIBIAL COMPONENT THE MALE PATIENT SUSTAINED A TIBIAL FRACTURE. SURGEON THINKS THAT THE PLACEMENT OF THE TIBIAL GPS TRACKER PINS PLACED CAUSED A WEAKNESS IN THE BONE WHICH SUBSEQUENTLY FRACTURED DURING TIBIAL IMPLANTATION. SURGEON ADDED A TIBIAL STEM AND SMITH AND NEPHEW PLATES/SCREWS TO SECURE THE SITE AND A SUCCESSFUL IMPLANTATION OF THE TIBIAL TRAY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE DEVICE REMAINS IMPLANTED. IT WAS REPORTED THAT IT APPEARS THERE WAS NO PATIENT IMPACT DUE TO A DELAY TO REPAIR THE FRACTURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 11359351 ↗