Truliant 02-022-51-2015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862307545), received between Sep 24, 2022 and Jun 3, 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.

• InjuryJun 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2021, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Failure of Implant; Inflammation; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19455698 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY, EXACTECH TRULIANT KNEE CLINICAL STUDY, THAT A 78 YO FEMALE, HEIGHT: 156CM, WEIGHT: 88 KGS, WHO HAD AN INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2021 FOR THE PRIMARY INDICATION OF OSTEOARTHRITIS, INDICATED THEY HAD INFECTION, INCREASED PAIN AND SWELLING IN RIGHT KNEE REPORTED AT 8-16-22 VISIT IN WHICH LABS WERE DONE SHOWING ELEVATED LEVELS FOR POSSIBLE INFECTION. REVISION WAS DONE ON (B)(6) 2022 WITH COMPETITORS¿ DEVICES. THE STUDY INDICATES THE OUTCOME AS RESOLVED, FUNCTIONAL RESTORATION TYPE AS FULL. RELATED TO DEVICE: DEFINITELY NOT, RELATED TO PROCEDURE: POSSIBLY.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15480667 ↗