Truliant 02-022-47-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862306289), received between Dec 6, 2023 and Dec 6, 2023 — classified as 1 injury.

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.

• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, THE 69 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2017. THE PATIENT PRESENTED ON (B)(6) 2023 WITH TRICOMPARTMENTAL DEGENERATIVE CHANGES WITH LATERAL JOINT SPACE NARROWING, SCLEROSING AND OSTEOPHYTE FORMATION. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. OUTCOME IS CONTINUING. PATIENT WAS HAVING DISCOMFORT; PAIN WAS RELATED MORE TO THE JOINT CAPSULE AND NOT THE HARDWARE. PATIENT DECLINED ELECTIVE REVISION SURGERY. TOPICAL ANESTHETIC CREAM WAS PRESCRIBED.

  Patient problems: Implant Pain; Pain

  MAUDE report 18279511 ↗