Truliant 02-022-48-3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862306852), received between Jul 13, 2023 and Dec 10, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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.

• InjuryDec 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 32 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INFLAMMATION, LOCAL MUSCULAR ATROPHY, EXCESSIVE FLUID BUILDUP CAUSING SWELLING, IMPLANT FAILURE, PAIN, DISABLING COMPLICATIONS, AND PERMANENT ALTERATION OF GAIT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Failure of Implant; Implant Pain; Inadequate Osseointegration; Inflammation; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 20894488 ↗
• InjuryJul 13, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST INITIAL TKA, THE 50 Y/O FEMALE PATIENT HAD A REVISION FOR AN UNKNOWN REASON. PATIENT HAD A RECALL DEVICE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint effusion; Swelling/ Edema; Synovitis

  MAUDE report 17316772 ↗