Truliant 02-022-51-5015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862307903), received between Jan 2, 2025 and Jan 2, 2025 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0023-2022 · Root cause: Process control · Recall details · FDA record ↗

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 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT DEVELOPED AN INFECTION WITHIN THE RIGHT TOTAL KNEE JOINT AND PRESENTED TO THE HOSPITAL WHERE THE PATIENT WAS SCHEDULED FOR IRRIGATION AND DEBRIDEMENT AND A POLY SWAP. APPROXIMATELY ONE MONTH AND SEVEN DAYS POST THE INITIAL TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED. THE JOINT WAS OPENED, DEBRIDED AND IRRIGATED WELL. THE POLY IMPLANT WAS SWAPPED TO A NEW ONE AND ANTIBIOTICS WERE PLACED LOCALLY WITHIN THE JOINT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21054195 ↗