Truliant 02-022-35-4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10885862304452), received between Feb 3, 2022 and Apr 4, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Naturally Worn” (13 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT. SUBSEQUENTLY, APPROXIMATELY 50 MONTHS LATER, THE IMPLANT WAS REPORTED TO HAVE BECAME DAMAGED AND FAILED, RESULTING IN UNSPECIFIED INJURY TO THE PATIENT THAT MAY REQUIRE REVISION SURGERY. NO REVISION SURGERY DATE WAS PROVIDED. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21773749 ↗
• InjuryFeb 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT STATED THEY UNDERWENT A KNEE REPLACEMENT AND HAVE HAD TROUBLE WITH THE KNEE FOR 6 YEARS. DATABASE SEARCH FOUND THEY UNDERWENT A REVISION PROCEDURE. REVISION PROCEDURE PERFORMED APPROXIMATELY 13 MONTHS AFTER INITIAL RIGHT KNEE PROCEDURE. NO FURTHER INFORMATION KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21305464 ↗
• InjuryJan 9, 2025Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2019. NOT YET REVISED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. PATIENT EXPERIENCED PROTHESIS WEAR, SEVERE PAIN, SCARRING, JOINT LAXITY, SWELLING, EFFUSION, ANTALGIC GAIT, INFLAMMATION, KNEE POPPING AND CRACKING, INSTABILITY, FIBROSIS, ANXIETY, EMOTIONAL DISTRESS. 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: Ambulation or Postural Difficulties; Fibrosis; Joint Laxity; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 21113486 ↗
• InjuryNov 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 46 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. INITIAL SURGERY OPERATIVE NOTES WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20668861 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 1 MONTHS AFTER A RIGHT 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: Insufficient Information

  MAUDE report 20311485 ↗
• InjurySep 17, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 50 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0023-2022.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Joint effusion; Loss of Range of Motion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20240465 ↗
• InjuryAug 8, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). (B)(4) LK REV RELATED. IT WAS REPORTED THAT APPROXIMATELY 19 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO SEVERE PAIN, SIGNIFICANT SCARRING, SWELLING, EFFUSION, INFLAMMATION, KNEE POPPING/CLUCKING, KNEE GIVING AWAY, DIFFICULTY WALKING, ANTALGIC GAIT AND OTHER INJURIES PRESENTLY UNDIAGNOSED. 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; Inflammation; Joint effusion; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19943633 ↗
• InjuryAug 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 10 MONTHS AFTER A RIGHT 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 19917824 ↗
• InjuryJun 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE RIGHT KNEE, WITH NO REVISION SURGERY REPORTED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF'S MOBILITY AND QUALITY OF LIFE. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19606934 ↗
• InjuryJun 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 53 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. DURING THE PROCEDURE IT WAS NOTED THE TIBIAL POLYETHYLENE COMPONENT SHOWED A VISIBLE AMOUNT OF POLYETHYLENE WEAR WITHIN THE WEIGHTBEARING PORTIONS OF THE POLYETHYLENE. THERE WAS SOME PITTING OF THE POLYETHYLENE COMPONENT AND SOME WEAR ON THE BACK SIDE OF THE TIBIAL POST. A MODERATE AMOUNT OF POLYETHYLENE DEBRIS WAS FOUND WITHIN THE ENCAPSULATED SYNOVIAL TISSUE. A COMPLETE SYNOVECTOMY WAS PERFORMED. THE TIBIAL, FEMORAL, AND PATELLAR COMPONENTS WERE FOUND TO BE WELL-FIXED. FOLLOWING THE PROCEDURE THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Synovitis

  MAUDE report 19509197 ↗
• InjuryApr 16, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020, WITH NO REPORTED REVISION. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Failure of Implant; Implant Pain; Loss of Range of Motion

  MAUDE report 19122661 ↗
• InjuryApr 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 , AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 1 YEARS AND 6 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19085787 ↗
• InjuryMar 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 2 YEARS, 4 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023- POSTOPERATIVE DIAGNOSIS: FAILED TOTAL KNEE, RIGHT, INITIAL ENCOUNTER. THE POLYETHYLENE INSERT WAS REMOVED. OF NOTE THERE WAS SOME WEAR BUT THERE WAS NO FRANK DELAMINATION OR FRACTURING OF THE IMPLANT. THE PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. THE PATIENT WAS TAKEN TO THE PACU IN STABLE CONDITION POSTOPERATIVE SHE WILL BE WEIGHTBEARING AS TOLERATED. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Osteolysis; Pain

  MAUDE report 18848686 ↗
• InjuryMar 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2023, 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Pain

  MAUDE report 18837810 ↗
• InjuryAug 23, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO THE POLY RECALL. THERE WAS NO REPORTED BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Extraskeletal ossification; Failure of Implant; Synovitis

  MAUDE report 17602637 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1.3 YEARS POST INITIAL LEFT TKA, THE 83 Y/O MALE PATIENT DEVELOPED AN INFECTION; THEREFORE, PATIENT NEEDED TO HAVE SOFT TISSUE CLEANED AND POLY SWAPPED OUT. PATIENT WAS DOWNSIZED TO A TRULIANT PS TIBIAL INSERT SIZE 4, 9MM. 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 IMAGES OR X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Bacterial Infection

  MAUDE report 17063376 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6)2022. THE PATIENT DEVELOPED AN INFECTION AND THEREFORE NEEDED TO HAVE SOFT TISSUE CLEANED AND POLY SWAPPED OUT ON (B)(6)2023. PATIENT WAS DOWNSIZED TO A TRULIANT PS TIB INSERT SIZE 4, 9MM. 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: Failure of Implant; Unspecified Infection

  MAUDE report 17045831 ↗
• InjuryJan 4, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS MALE PATIENT IS APPROXIMATELY 2 YRS POSTOP L TKA, IS NOW SCHEDULED FOR A LINER REPLACEMENT ON (B)(6) 2023, DUE TO THE RECALL FROM EXACTECH. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Failure of Implant; Inflammation; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16096072 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY THREE MONTHS POST INITIAL TKA, THE 58 Y/O MALE PATIENT COMPLAINS OF STIFFNESS IN BOTH KNEES. PATIENT HAD X-RAYS AND ZILRETTA INJECTIONS. PATIENT WAS ORDERED EVALUATION AND THERAPY AND THE EVENT WAS RESOLVED. PER CLINICAL STUDY CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Arthrofibrosis; Pain

  MAUDE report 15191784 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1 YEAR AND 8 MONTHS POST INITIAL RIGHT TKA, THIS MALE PATIENT UNDERWENT REVISION DUE TO INSTABILITY. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13441071 ↗