Truliant 02-022-47-4010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862311382), received between Nov 2, 2022 and Oct 9, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K171045); they may or may not involve this specific model.

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.

• InjuryOct 9, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAS A HISTORY OF 2 SYNOVECTOMIES THROUGH KNEE SCOPE. THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2021. THE PATIENT PRESENTED WITH SIGNS OF INFECTION. THE PATIENT HAD A POLY EXCHANGE ON (B)(6) 2023 AND I&D WAS PERFORMED. POLY WEAR WAS VISUAL ON MEDIAL COMPARTMENT WITH PITTING. NO ISSUES WITH SURGERY. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 17902037 ↗
• InjuryNov 2, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP THE INITIAL RIGHT TKA, THIS MALE PATIENT WAS REVISED DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. FOLLOWING THE REVISION SURGERY, PLAINTIFF CONTINUES TO BE LIMITED IN HIS ACTIVITIES OF DAILY LIVING. DESPITE UNDERGOING REVISION SURGERY, PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS RIGHT KNEE WHICH LIMITS HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE.

  Patient problems: Failure of Implant

  MAUDE report 15713601 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171045. One submission often covers many models, so check the product and lot details in each record.

• Z-0585-2024 · Nov 21, 2023 · Open, Classified
  Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-