Truliant 02-022-35-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862304087), received between Jul 7, 2022 and Feb 12, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020, WITH REVISION REPORTED ON (B)(6) 2022. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18692391 ↗
• InjuryFeb 3, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, THE 70 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018 AND PRESENTED WITH LIGAMENT LAXITY 2 YEAR(S) AND 2 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2022. THE PATIENT COMPLAINED OF PAIN AND INSTABILITY. RX'D HINGED KNEE BRACE FOR LIGAMENT LAXITY CAUSING SLIGHT BILATERAL OPENING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE REPORT ALSO INDICATES THAT THE ACTION OF PRESCRIBING A HINGED KNEE BRACE WAS TAKEN AND THE OUTCOME WAS RESOLVED ON (B)(6) 2022. DUE TO CLINICAL STUDY, NO DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18637116 ↗
• InjuryJul 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED BY THE LEGAL DEPARTMENT, APPROXIMATELY 3 YEARS POST OP THE INITIAL TKA, THIS FEMALE PATIENT WAS REVISED. REASON WAS NOT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 14944762 ↗