Truliant 02-022-44-4010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862305275), received between Jul 28, 2022 and May 31, 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.

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.

• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA EXACTECH TRULIANT KNEE CLINICAL STUDY, THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2023, UNDERWENT A POLY REVISION PROCEDURE ON (B)(6) 2023, DUE TO A WOUND INFECTION. DATE OF ONSET, (B)(6) 2023. THE STUDY INDICATED THE PATIENT WAS SEEN AT A SCHEDULED CLINIC APPOINTMENT AND WAS PRESCRIBED AN ORAL ANTIBIOTIC FOR MILD PREPATELLAR BURSITIS. THE FOLLOW-UP CLINIC VISIT ON (B)(6) 2023, SHOWED IMPROVEMENT IN SYMPTOMS. ON (B)(6) 2023, THE PATIENT STATED THEY DEVELOPED LEFT KNEE EDEMA, PAIN, AND REDNESS, AND ON (B)(6), 2023, THEY PRESENTED TO THE ER FOR WORSENED SYMPTOMS. THEY WERE ADMITTED TO THE HOSPITAL, AND 3.375 G IV Q8H WAS ORDERED. WBC (B)(6) 2023 HIGH @3:18 AM 24.42 AND @6:57 AM 18.63. CT WITH IV CONTRAST REPORTED LARGE PERIPHERAL SUBCUTANEOUS FLUID COLLECTION ANTERIOR ASPECT OF LEFT KNEE SUSPICIOUS FOR ABSCESS. SMALL TO MODERATE KNEE JOINT EFFUSION WITH SYNOVITIS SUSPICIOUS FOR SEPTIC ARTHRITIS. KNEE JOINT ASPIRATION RECOMMENDED. LEFT KNEE SURGERY FOR DRAINAGE WITH EXCHANGE OF POLY LINER LTKA PERFORMED ON (B)(6) 2023, FOR PYOGENIC ARTHRITIS OF LEFT KNEE JOINT, DUE TO UNSPECIFIED ORGANISM. PER PI EXCHANGE IS SOC FOR TKA INFECTION AND UPON CAREFUL IN

  Patient problems: Medical device site infection; Pain; Swelling/ Edema; Wound Infection

  MAUDE report 17031274 ↗
• InjuryJul 28, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS PATIENT HAD A TKA ON (B)(6) 2019 PERFORMED BY DR. (B)(6). THE PATIENT PRESENTED WITH PAIN AND SYNOVITIS AND WAS REVISED ON (B)(6) 2022 AND A NEW INSERT WAS PLACED. ONLY MILD WEAR WAS NOTED. THE PATIENT HAD GOOD ROM AND WAS LAST KNOWN TO BE IN STABLE CONDITION.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 15121694 ↗

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-