Truliant 02-022-35-3010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862304261), received between Jun 22, 2022 and Aug 22, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

2 FDA recall records name this device's identifier, 2 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. Nov 21, 2023Class IIOpen, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0585-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

2. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 28 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20026546 ↗
• InjuryJun 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 13 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19458726 ↗
• InjuryJun 22, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL BRIEF, MALE PATIENT UNDERWENT BI-LATERAL KNEE REPLACEMENT ON OR ABOUT (B)(6) 2019. THE SURGEON USED TRULLIANT TIBIAL INSERTS FOR BOTH KNEE REPLACEMENTS. THESE PRODUCTS WERE MANUFACTURED BY EXACTECH INC. AND HAVE SINCE BEEN RECALLED BY EXACTECH. FOLLOWING THE INITIAL OPERATIONS, PATIENT HAS SUFFERED INJURIES AND DAMAGES DUE TO THE DEFECTIVE PRODUCTS, INCLUDING BUT NOT LIMITED TO, ADDITIONAL SURGICAL INTERVENTIONS.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 14781790 ↗