Truliant 02-022-47-5009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862306579), received between Mar 15, 2022 and May 8, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT KNEE ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS, 10 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 19274629 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY TWO MONTHS POST INITIAL TKA, THIS MALE PATIENT RIGHT KNEE WAS WASHED OUT FOR SUSPECTED INFECTION. CULTURES WERE SENT TO LAB. A NEW SIZE 5 9MM INSERT WAS PLACED. PATIENT WAS LAST KNOW TO BE IN STABLE CONDITION. PHOTOS RECEIVED. THE EXPLANT NOT AVAILABLE FOR RETURN.

  Patient problems: Bacterial Infection

  MAUDE report 13771619 ↗