Truliant 02-022-47-4015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862306500), received between Oct 5, 2022 and Oct 5, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS MALE PATIENT'S LEFT KNEE WAS REVISED 2 YEARS POST OP DUE TO DAILY PAIN AND DISCOMFORT WHICH LIMITS HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE. FOLLOWING REVISION SURGERY, PATIENT IS CONTINUES TO BE LIMITED IN HIS ACTIVITIES OF DAILY LIVING. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Discomfort; Failure of Implant; Impaired Healing; Pain

  MAUDE report 15546387 ↗