Truliant 02-022-44-4012Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862305299), received between Apr 6, 2022 and Mar 14, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DATABASE REVIEW FOR A RELATED CASE, IT WAS FOUND THAT A PATIENT HAD UNDERWENT A REVISION PROCEDURE OF THEIR RIGHT KNEE WHICH WAS INITIALLY IMPLANTED IN (B)(6) 2019. THE TIBIAL PSC INSERT WAS REVISED IN (B)(6) 2021 APPROXIMATELY 1 YEAR 10 MONTHS POST THE INITIAL PROCEDURE. REASON FOR THE REVISION IS UNKNOWN. THE TIBIAL IMPLANT WAS REVISED TO SAME DEVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS IS 1 OF 2 EVENTS.

  Patient problems: Insufficient Information

  MAUDE report 21608391 ↗
• InjuryMar 3, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, RIGHT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025, APPROXIMATELY 5 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO PAIN. THE TIBIA WAS REVISED WITH STEM AND AUGMENTS. TIBIA WAS REVISED DUE TO WEAR AND OSTEOLYSIS. IT WAS STATED THERE WERE NO ISSUES WITH THE SURGERY. X-RAYS WERE NOT PROVIDED. EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 21510613 ↗
• InjuryOct 10, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2021. APPROXIMATELY 1 YEAR AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN

  Patient problems: Insufficient Information; Joint Laxity; Joint effusion; Pain; Scar Tissue; Synovitis

  MAUDE report 17906248 ↗
• InjuryApr 6, 2023Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY 4.1 YEARS POST INITIAL LEFT TKA, THE 59 YEAR OLD MALE PATIENT HAD A REVISION DUE TO PREMATURE POLY WEAR AND POLY RECALL WITH OSTEOLYSIS AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. DURING REVISION SURGERY, IT WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WERE FOUND TO BE GROSSLY LOOSE FEMORAL AND TIBIAL COMPONENTS THAT WERE EASILY REMOVED WITH A BONE TAMP. THERE WAS ALSO FOUND TO BE A WELL-FIXED PATELLAR BUTTON. THERE WAS A MODERATE AMOUNT OF POLYETHYLENE WEAR, BOTH VISIBLY AND PALPABLE ON THE TIBIAL POLYETHYLENE COMPONENT. THERE WAS ENCAPSULATED POLYETHYLENE DEBRIS WITHIN THE SYNOVIUM AND A COMPLETE SYNOVECTOMY WAS PERFORMED. PATIENT WAS REVISED TO COMPETITORS DEVICES. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16696863 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, PATIENT SAID THAT SINCE HIS SURGERY HIS KNEE HAS BEEN SWOLLEN AND HE HAS BEEN IN PAIN. HE SAID THAT HIS SURGEON SAID HE WILL NEED A REVISION BECAUSE HE IS ¿HIGHLY ALLERGIC TO NICKEL¿. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14024950 ↗

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-