Truliant 02-022-51-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862307521), received between Aug 20, 2024 and Feb 2, 2026 — 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 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, 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.

• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE SURGEON PERFORMED A LINER EXCHANGE AND REMOVAL OF SCAR TISSUE DUE TO PATIENT REPORTS OF PAIN. NO ISSUES WITH SURGERY REPORTED.

  Patient problems: Pain

  MAUDE report 24232950 ↗
• InjuryAug 20, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 002670) CASE NO. (B)(4) FOR RK 1ST REV. IT WAS REPORTED THAT APPROXIMATELY 31 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20001453 ↗