Truliant 02-022-51-4013Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862307774), received between Oct 5, 2021 and Jul 2, 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.

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.

• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY ONE MONTH AFTER A LEFT KNEE REVISION PROCEDURE, THE PATIENT EXPERIENCED AN INFECTION WITHIN THE TOTAL KNEE JOINT. THE PATIENT WAS REVISED TO A NEW TIBIAL INSERT AND TREATED WITH IV ANTIBIOTICS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22383743 ↗
• InjuryOct 17, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 41 MONTHS AFTER A LEFT TOTAL KNEE REVISION PROCEDURE, THE PATIENT HAS EXPERIENCED JOINT SWELLING, PAIN, DISCOMFORT, LOSS OF MOBILITY AND INSTABILITY AND WILL REQUIRE A SECOND REVISION SURGERY. AT THE TIME OF LEGAL NOTIFICATION, A SECOND REVISION PROCEDURE HAD NOT BEEN PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20470567 ↗
• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 24 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19271400 ↗
• InjuryApr 22, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016 AND THEN WAS REVISED ON (B)(6) 2022. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO PAIN, SWELLING, AND DECREASED RANGE OF MOTION.

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

  MAUDE report 19152770 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY ONE-MONTH POST LTKA, THE PATIENT SUBJECT CAME TO CLINIC WITH WOUND DRAINAGE AND SCHEDULED FOR REVISION AND I&D. THE EVENT IS NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE. INFORMATION RECEIVED FROM CLINICAL STUDY DATABASE. OUTCOME WAS NOTED AS RESOLVED. NO OTHER INFORMATION AVAILABLE AT THIS TIME. DEVICE WILL NOT RETURN DUE TO STUDY PROTOCOL.

  Patient problems: Bacterial Infection

  MAUDE report 12579056 ↗