Truliant 02-022-47-2015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862306302), received between Dec 3, 2021 and Apr 12, 2023 — 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.

• InjuryApr 12, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY LEGAL, APPROXIMATELY 1.5 YEARS POST OP THE LEFT INITIAL TKA, THIS 57 Y/O FEMALE PATIENT WAS REVISED. THERE WAS NO GROSS LOOSENESS OF EITHER COMPONENT. THE POLYETHYLENE SHOWED EVIDENCE OF MILD WEAR. REVISED TO EXACTECH DEVICES. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Pain

  MAUDE report 16723224 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(6) CLINICAL STUDY, APPROXIMATELY 2.5 YEARS POST ORIGINAL TKA, THE PATIENT INCREASED PAIN. WHEN CALLED FOR FOLLOW UP, PATIENT STATED SHE HAD A REVISION BY AN OUTSIDE SURGEON IN (B)(6) 2021 DUE TO INCREASED PAIN. PATIENT WOULD NOT PROVIDE ANY FURTHER INFORMATION ABOUT THE REVISION SURGERY. THE EVENT IS NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 12923659 ↗