Truliant 02-022-35-4013Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10885862304476), received between Feb 18, 2021 and Jul 14, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Naturally Worn” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THIS 58-YEAR-OLD, MALE PATIENT HAD A LEFT INITIAL TKA. THE PRESS FIT FEMORAL COMPONENT SHOWED LOOSE ON A BONE SCAN AND THE PATIENT WAS REVISED. THE PATIENT WAS REVISED TO A CONSTRAINED SIZE 4 LEFT SIDE AND A SIZE 4/13MM PS LINER WITH A 18X80 CEMENTED STEM. 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. NO FURTHER INFORMATION. PHOTOS AND X-RAYS PROVIDED. THE DEVICES ARE RETURNING ON RG589738. 510K: K181794.

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

  MAUDE report 22493077 ↗
• InjuryFeb 25, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 70 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT WAS REVISED TO COMPETITOR¿S DEVICES TO ADDRESS PROTHESIS WEAR AND PAIN. THERE WAS NO BREAKAGE OF DEVICES OR SURGICAL PROLONGATION/DELAY. DEVICE WILL NOT BE RETURNED, PER HOSPITAL POLICY. X-RAYS AND IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 21458882 ↗
• InjuryDec 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 41 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROSTHESIS WEAR, FAILURE OF IMPLANT, AND PAIN. INITIAL SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20924772 ↗
• InjuryOct 17, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 33 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. PLAINTIFF (B)(6) IS CURRENTLY SUFFERING FROM THE FOLLOWING COMPLICATIONS, INJURIES AND/OR INDICATIONS, SOME OF ALL OF WHICH MADE REVISIONS MEDICALLY NECESSARY; PAIN, DISCOMFORT, AND DIFFICULTY WALKING AS A RESULT OF THE DEFECTIVE NATURE OF THE EXACTECH KNEE REPLACEMENT SYSTEM. PLAINTIFF HAS SUFFERED, AND CONTINUE TO SUFFER, SEVERE AND PERMANENT PERSONAL INJURIES, INCLUDING POLYETHYLENE WEAR AND DEVICE FAILURE, DISBURSEMENT OR THE POLYETHYLENE LINER INTO BONE AND OTHER BODY STRUCTURES, PAINFUL KNEE REVISION SURGERIES TO REMOVE OR REVISE THE DEFECTIVE DEVICE, CONTINUED REHABILITATION MEDICAL CARE AND POSSIBLY ADDITIONAL SURGERIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain

  MAUDE report 20475049 ↗
• InjurySep 4, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 57 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND INSTABILITY. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20134761 ↗
• InjuryAug 9, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ (B)(4). PATIENT ID: (B)(6). CASE-(B)(4), RIGHT KNEE IS ASSOCIATED WITH THIS CASE. 7/24/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 7/24/24. INDICATION FOR PROCEDURE: OVER THE PAST FEW YEARS, THE PATIENT HAS HAD RECURRENT LARGE EFFUSIONS IN THE LEFT KNEE. INFECTION WORKUP HAS BEEN NEGATIVE. X-RAYS SHOW SIGNIFICANT INCREASING OSTEOLYSIS IN THE FEMUR. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR, MASSIVE OSTEOLYSIS AND FEMORAL LOOSENING. DESCRIPTION OF PROCEDURE: THERE WAS SIGNIFICANT OSTEOLYTIC DEBRIS IN THE KNEE. SUBTOTAL SYNOVECTOMY WAS PERFORMED. THE PATELLA WAS EVERTED AND FOUND TO BE OXIDIZED WITH LOSS OF POLYETHYLENE. THERE WAS A LARGE CAVITARY DEFECT IN THE INFERIOR ASPECT OF THE PATELLA. THE PATELLA WAS SUBLUXED, KNEE WAS FLEXED, INSERT WAS REMOVED. FEMORAL COMPONENT WAS DISIMPACTED FROM THE CEMENT MANTLE. AT THIS POINT, THE TIBIA WAS EXPOSED CIRCUMFERENTIALLY AND OSTEOLYTIC DEBRIS WAS DEBRIDED FROM THE UNDERNEATH THE TIBIAL PLATEAU. THE TIBIA WAS WELL FIXED AND WAS LEFT IN PLACE. AT THIS POINT, OSTEOLYTIC TISSUE WAS DEBRIDED FROM THE FEMUR AND THERE WERE LARGE UNCONTAINED DEFECTS IN TH

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint effusion; Osteolysis

  MAUDE report 19948320 ↗
• InjuryAug 9, 2024Corroded; Loosening of Implant Not Related to Bone-Ingrowth; Corroded; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE: (B)(4). PATIENT ID: (B)(6) + LEFT KNEE (B)(4), RIGHT KNEE IS ASSOCIATED WITH THIS CASE. 7/24/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 7/24/24. ATTACHED EMAIL AND REVISION OP REPORT. INDICATION FOR PROCEDURE: OVER THE PAST FEW YEARS, THE PATIENT HAS HAD RECURRENT LARGE EFFUSIONS IN THE LEFT KNEE. INFECTION WORKUP HAS BEEN NEGATIVE. X-RAYS SHOW SIGNIFICANT INCREASING OSTEOLYSIS IN THE FEMUR. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR, MASSIVE OSTEOLYSIS AND FEMORAL LOOSENING. DESCRIPTION OF PROCEDURE: THERE WAS SIGNIFICANT OSTEOLYTIC DEBRIS IN THE KNEE. SUBTOTAL SYNOVECTOMY WAS PERFORMED. THE PATELLA WAS EVERTED AND FOUND TO BE OXIDIZED WITH LOSS OF POLYETHYLENE. THERE WAS A LARGE CAVITARY DEFECT IN THE INFERIOR ASPECT OF THE PATELLA. THE PATELLA WAS SUBLUXED, KNEE WAS FLEXED, INSERT WAS REMOVED. FEMORAL COMPONENT WAS DISIMPACTED FROM THE CEMENT MANTLE. AT THIS POINT, THE TIBIA WAS EXPOSED CIRCUMFERENTIALLY AND OSTEOLYTIC DEBRIS WAS DEBRIDED FROM THE UNDERNEATH THE TIBIAL PLATEAU. THE TIBIA WAS WELL FIXED AND WAS LEFT IN PLACE. AT THIS POINT, OSTEOLYTIC TISSUE WAS DEBRIDED FROM THE FEMUR AN

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint effusion; Osteolysis

  MAUDE report 19948257 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 3 YEARS AND 10 MONTHS POST THE PREVIOUS LEFT REVISION, THE PATIENT WAS REVISED AGAIN BECAUSE THE PATELLA FELL OUT AND HAD TO BE BONE GRAFTED DUE TO OSTEOLYSIS OF THE PATELLA. THE PATIENT WILL REQUIRE AN ADDITIONAL SURGERY TO REPAIR THE PATELLA ONCE THE BONE GRAFT HAS GROWN NEW BONE. 30CC OF BONE GRAFT WAS USED TO GRAFT THE PATIENT'S PATELLA. 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: Osteolysis

  MAUDE report 19946010 ↗
• InjuryJul 26, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 25 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR UNKNOWN ISSUES. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 19838891 ↗
• InjuryJul 24, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 25 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, FUTURE DAMAGES INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE, REHABILITATION, MENTAL AND EMOTIONAL DISTRESS, AND PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19816377 ↗
• InjuryJun 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 141 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR LEFT SIDE REVISED: PREMATURE, UNNECESSARY REVISION SURGERY. TISSUE AND BONES LOSS.. 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; Failure of Implant; Implant Pain; Joint effusion; Osteolysis

  MAUDE report 19594121 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 73 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19502889 ↗
• InjuryMay 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT KNEE ARTHROPLASTY ON (B)(6) 2019, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19298971 ↗
• InjuryFeb 29, 2024Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022, WITH NO REVISION SURGERY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Pain; Swelling/ Edema

  MAUDE report 18807674 ↗
• InjurySep 25, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2017. THE PATIENT COMPLAINED OF PAIN AND HAD A RECALLED POLY AND WAS REVISED ON (B)(6) 2023. 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: Cyst(s); Failure of Implant; Joint Laxity; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 17808280 ↗
• InjurySep 20, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2020. THIS DEVICE HAS NOT BEEN EXPLANTED. 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 COMPLAINT IN A COORDINATED ACTION IN (B)(6) COUNTY WITH MASTER CASE NO. (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 EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 17783207 ↗
• InjuryJul 11, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6)2018. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6)2023, APPROXIMATELY 4 YEARS 6 MONTHS AFTER THEIR PRIMARY PROCEDURE. THE PATIENT HAS CLAIMED THE FOLLOWING INJURIES/COMPLICATIONS: NEW AND WORSENING PAIN IN KNEE, PAIN WHILE WALKING, INABILITY TO BEAR WEIGHT ON JOINT, CONSTANT SWELLING IN KNEE, INSTABILITY IN THE KNEE, AND DEVICE FAILURE. 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.

  Patient problems: Failure of Implant; Implant Pain; Insufficient Information; Joint Laxity; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 17300576 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS (B)(6) MALE PATIENT LEFT KNEE WAS REVISED DUE TO SWELLING AND THE SURGEON CHANGED THE INSERT WHILE IN THERE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL RETURN.

  Patient problems: Failure of Implant

  MAUDE report 11346315 ↗