Truliant 02-022-35-2009Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862304063), received between May 26, 2022 and Apr 24, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 21 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED DAILY PAIN AND DISCOMFORT IN HER RIGHT KNEE; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; AND OTHER INJURIES PRESENTLY UNDIAGNOSED. THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS INFECTION AND COMPONENT PART LOOSENING. IT WAS NOTED THE PATIENT WAS REVISED TO A COMPETITOR'S FEMORAL COMPONENT. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Implant Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 21900724 ↗
• InjuryMar 26, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 3 YEARS 4 MONTHS POST OPERATION. DURING SURGERY, THE SURGEON REALIZED THE FEMORAL COMPONENT WAS GROSSLY LOOSE AND FELL RIGHT OFF, LEAVING A PERFECT CEMENT MANTLE ON THE BONE. SURGEON REVISED THE FEMUR TO A LOGIC CC FEMUR, ADDED A 14 X80 STEM EXTENSION AND INSERTED A NEW 2 X 10 PS POLY. NO FRAGMENTS, PARTS OR PIECES FELL INTO THE PATIENT. NO PARTS OR PIECES OF THE DEVICE FELL INTO THE PATIENT WOUND SITE. REPORTED EVENT LED TO >45 MINUTE SURGICAL DELAY/PROLONGATION. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE SURGICAL DELAY/PROLONGATION. PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE.

  Patient problems: Pain

  MAUDE report 21697861 ↗
• InjuryFeb 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 4 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO A SWOLLEN, PAINFUL KNEE. THE POLY WAS REVISED TO A NEW POLY. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Implant Pain; Pain; Swelling/ Edema

  MAUDE report 21442759 ↗
• InjuryJun 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 33 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DISCOMFORT, SWELLING, CLICKING, GRINDING, GAIT IMPAIRMENT, POOR BALANCE, SOFT TISSUE DAMAGE, BONE LOSS, AND BONE DAMAGE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19454104 ↗
• InjuryNov 16, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 1 YEAR AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2019. 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 MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4), AND PENDING IN THE EASTERN DISTRICT OF (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Implant Pain; Insufficient Information; Swelling/ Edema

  MAUDE report 18147843 ↗
• InjuryAug 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A 55 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON WITH PAIN. A LOOSE FEMUR AND RECALLED POLY WERE INDICATED. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. A DEVICE IMAGE AND AN X-RAY WERE PROVIDED. NO PATIENT HISTORY OR COMORBIDITIES KNOWN. THE DEVICE IS NOT AVAILABLE FOR RETURN, DUE TO THE RECALL, THE HOSPITAL WILL NOT RELEASE IT. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 17586584 ↗
• InjuryApr 4, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 50 YO FEMALE PATIENT WAS EXPERIENCING INSTABILITY TOTAL KNEE ARTHROPLASTY. THE DATE OF ADVERSE EVENT ONSET IS (B)(6) 2020. THE PATIENT WAS TREATED WITH CONSERVATIVE MEASURES OVER THE LAST YEAR CONSISTING OF ACTIVITY MODIFICATION, ASSISTIVE DEVICE USE, NSAIDS, PT, AND WEIGHT LOSS ATTEMPTS WERE UNSUCCESSFUL, AND GROSS GLOBAL EXTENSION AND FLEXION INSTABILITY WERE OBSERVED. PHYSICIAN ENDORSED SYNOVECTOMY AND LINER EXCHANGE. THE PATIENT WAS REVISED ON (B)(6) 2020. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2020.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16678638 ↗
• InjuryDec 28, 2022Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST OP THE INITIAL TSA, THIS 70 Y/O FEMALE PATIENT WAS REVISED DUE TO ASEPTIC FEMORAL LOOSENING AND RECALLED POLYETHYLENE INSERT. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES AND PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16064131 ↗
• InjuryDec 5, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY THREE YEARS POST INITIAL LEFT SIDE TKA FOR PRIMARY OSTEOARTHRITIS, THE OBESE FEMALE PATIENT EXPERIENCED INSTABILITY OF LEFT KNEE. PATIENT HAD CONSERVATIVE MEASURES OVER THE LAST YEAR CONSISTING OF ACTIVITY MODIFICATION, ASSISTIVE DEVICE USE, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS), PHYSICAL THERAPY, AND WEIGHT LOSS ATTEMPTS WERE UNSUCCESSFUL, AND GROSS GLOBAL EXTENSION AND FLEXION INSTABILITY WERE OBSERVED, SURGEON ENDORSED SYNOVECTOMY AND LINER EXCHANGE TO PATIENT. PATIENT HAD A REVISION ON (B)(6) 2020. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15915817 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  IT WAS REPORTED VIA A CLINICAL STUDY, TRULIANT KNEE CLINICAL STUDY, THAT A FEMALE 53 YO CAUCASIAN PATIENT, HEIGHT: 69 IN, WEIGHT: 210 LBS, WHO WAS INITIALLY IMPLANTED ON (B)(6) 2022, FOR THE PRIMARY DIAGNOSIS OF OSTEOARTHRITIS, PRESENTED TO THE CLINIC WITH ARTHROFIBROSIS - STIFFNESS AND INADEQUATE ROM, DATE OF EVENT ONSET, (B)(6) 2022. MANIPULATION UNDER ANESTHESIA TO BE SCHEDULED. THE STUDY INDICATES THE EVENT IS DEFINITELY NOT RELATED TO DEVICE, AND DEFINITELY RELATED TO PROCEDURE. OUTCOME IS CONTINUING.

  Patient problems: Arthrofibrosis; Loss of Range of Motion

  MAUDE report 15568196 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2017. THE PATIENT HAS FAILED CONSERVATIVE MANAGEMENT TO INCLUDE NSAIDS, PHYSICAL THERAPY, STEROID INJECTION, ASSISTIVE DEVICES AND LIFE STYLE MODIFICATIONS. DUE TO WORSENING PAIN IN LEFT REPLACED KNEE, A POSITIVE BONE SCAN AROUND FEMUR, DETERIORATING RANGE OF MOTION, PROGRESSIVE DEFORMITY, AND SIGNIFICANT INTERFERENCE WITH FUNCTION, THE ONLY OPTION FOR PAIN CONTROL AND FUNCTIONAL RESTORATION IS A TOTAL KNEE REPLACEMENT REVISION. THE PATIENT HAD A COMPLETE FEMORAL REVISION WITH POLYETHYLENE EXCHANGE AND RETENTION OF PATELLAR COMPONENT ON (B)(6) 2020. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Deformity/ Disfigurement; Failure of Implant; Loss of Range of Motion; Pain

  MAUDE report 15538623 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, SURGEON WENT TO RESURFACE PATELLA AND JUST DECIDED TO EXCHANGE POLY WHILE HE WAS DOING THE PROCEDURE. PATIENT WAS REVISED TO A NEW POLY. THERE WAS NO BREAKAGE IN THE DEVICE AND NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SALES REP WAS UNABLE TO OBTAIN PHOTOS OR X-RAYS.

  Patient problems: Failure of Implant

  MAUDE report 14518968 ↗