Truliant 02-020-12-0335Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862314901), received between Jun 13, 2022 and Feb 20, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL NOTIFICATION: A MALE PATIENT HAD AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2020, AND THEN UNDERWENT REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 2 YEARS AFTER IMPLANT PROCEDURE. REVISION SURGERY OPERATIVE REPORT OF (B)(6) 2022-FAILED RIGHT KNEE ARTHROPLASTY SECONDARY TO ASEPTIC LOOSENING AND POLY WEAR. OBESE BMI 37-THE DURATION OF THE PROCEDURE WAS INCREASED BY APPROXIMATELY 40%, DUE TO PATIENT SIZE, THIS INCREASED COMPLEXITY AND DIFFICULTY OF SURGICAL PROCEDURE.

  Patient problems: Implant Pain; Scar Tissue

  MAUDE report 21426837 ↗
• InjuryJun 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT EXPERIENCED A RIGHT KNEE SURGICAL PROCEDURE APPROXIMATELY 2 YEARS 2 MONTHS POST INITIAL IMPLANT. PREOPERATIVE DIAGNOSES: FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO PREMATURE POLYETHYLENE WEAR FROM A RECALLED POLYETHYLENE INSERT AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. REVISION RIGHT. TOTAL KNEE ARTHROPLASTY OF FEMORAL, TIBIAL, AND PATELLAR COMPONENTS. PATIENT WAS REVISED TO COMPETITOR'S IMPLANTS. INFECTION WORK-UP WAS NEGATIVE. THERE WAS SOME EARLY POLYETHYLENE SYNOVITIS, BUT NO SIGNS OF INFECTION OR PURULENCE. THERE WAS EARLY WEAR OF THE PATELLAR BUTTON ON THE LATERAL FACET WITH FLATTENING, IT WAS EXCHANGED. ON GROSS INSPECTION OF THE TIBIAL INSERT, THERE WERE NO OBVIOUS SIGNS OF SIGNIFICANT WEAR, THERE WERE A COUPLE OF AREAS OF SOME PINNING. THERE WAS FAILURE OF BONY INGROWTH FOR THE FEMORAL COMPONENT, IT WAS REMOVED. TIBIAL COMPONENT WAS REMOVED. TILE PATIENT WAS AWOKEN FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS. DEVICE WILL NOT BE RETURNED. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE

  Patient problems: Emotional Changes; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19567727 ↗
• MalfunctionDec 13, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING SET UP, THE SURRAN WRAPPED FEMORAL IMPLANT PACKAGE WAS OPENED. THE TAMPER EVIDENT TAB WAS STILL INTACT WITH NO SIGNS OF TAMPERING. THE TAB WAS OPENED. THE FEMORAL IMPLANT REMOVED. WHILE STARTING TO PEEL BACK TO EXPOSE THE STERILE CONTENTS, IT WAS NOTICED THAT THE PAPER WAS NOT FULLY SEALED AND ALREADY LOOSE AND OPEN. THE STERILE CONTENT ALSO HAD A PACKAGING ISSUE WHERE THE SEAL BETWEEN THE PAPER AND THE PLASTIC PEEL PART WAS SEEN FOLDED BACK AND NOT SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15972086 ↗
• InjuryJun 13, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FIVE MONTHS POST INITIAL RIGHT TKA, THE 66 Y/O FEMALE PATIENT COMPLAINED OF PAIN AND HAD A REVISION DUE TO LOOSE FEMUR. SURGEON USED A DEVICE FROM ANOTHER COMPANY FOR REVISION. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS HOSPITAL WILL NOT RELEASE THE IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 14680237 ↗