Truliant 02-020-11-0335Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862314550), received between Mar 6, 2023 and Sep 29, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Patient problems: Pain

  MAUDE report 50936034 ↗
• InjuryMay 12, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY AND OPERATIVE NOTES, THE PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT SURGERY. THE PATIENT HAD INITIALLY DONE WELL BUT STARTED HAVING INCREASED PAIN AND SWELLING. AN INFECTION WORKUP WAS NEGATIVE. APPROXIMATELY 4 YEARS AND 4 MONTHS POST THE INITIAL SURGERY; THE PATIENT¿S RIGHT KNEE WAS REVISED TO NON-EXACTECH COMPONENTS DUE TO SUSPECTED POLYETHYLENE WEAR AND FEMORAL COMPONENT LOOSENING. PER THE OPERATIVE NOTES, THERE WAS A TYPICAL SYNOVITIS WITH PARTICULATE DEBRIS AND THE SYNOVIAL TISSUE IN THE MEDIAL AND LATERAL GUTTERS. THERE WAS BROWNISH DISCOLORATION AS WELL AND LOOKED GRITTY. SURGEON DEBRIDED THIS SYNOVIAL TISSUE AND SENT A SAMPLE OF THE TISSUE FOR CULTURE. THERE WERE NO SIGNS OF PURULENCE OR INFECTION. ON GROSS INSPECTION, THERE WAS NO SIGNIFICANT WEAR (TO THE TIBIAL INSERT). THERE WERE SOME PITTING CHANGES IN THE ARTICULAR SURFACE, PRIMARILY MEDIALLY AND THE FEMORAL COMPONENT WAS DISIMPACTED WITHOUT ANY DIFFICULTIES AS THERE WAS NO ATTACHMENT TO THE CEMENT MANTLE. ADDITIONALLY, THERE WAS GROSS DAMAGE TO THE PATELLAR BUTTON. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CO

  Patient problems: Aseptic loosening; Pain; Swelling/ Edema; Synovitis

  MAUDE report 25150239 ↗
• InjuryJan 28, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON 23MAR2018. APPROXIMATELY 4 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. PATIENT HAS EXPERIENCED PROSTHESIS WEAR, FEMORAL LOOSENING, OSTEOLYSIS AND SYNOVITIS. REVISION OP REPORT ON (B)(6) 2023 DIAGNOSIS: FAILED POLYETHYLENE COMPONENT, RIGHT TOTAL KNEE DUE TO WEAR WITH LOOSE FEMORAL COMPONENT. FINDINGS: THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS EVIDENCE OF POLYETHYLENE WEAR WITH ENCAPSULATED POLYETHYLENE DEBRIS WITHIN THE SYNOVIUM AND A COMPLETE SYNOVECTOMY WAS PERFORMED. THERE WAS FOUND TO BE A LOOSE FEMORAL COMPONENT FROM THE CEMENT MANTLE AND THERE WAS AN UN-RESURFACED PATELLA DUE TO A THIN, NATIVE, WORN PATELLA FROM PREVIOUS SURGERY. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Joint Laxity; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21256347 ↗
• InjuryJan 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 04-DEC-2023. LEGAL CASE ¿ USA (MDL NO. 3044). PATIENT ID: (B)(6). RELATED CASE-(B)(4). 15. PLAINTIFF WAS IMPLANTED WITH THE FOLLOWING EXACTECH DEVICE: TRULIANT. 16. LEG IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: RIGHT. 17. DATE THE EXACTECH DEVICE WAS IMPLANTED: (B)(6) 2018. 18. STATE IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: OH. 19. DATE THE EXACTECH DEVICE WAS SURGICALLY REMOVED/REVISED: (B)(6) 2022. 20. PLAINTIFF HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS AS A RESULT OF THIS EXACTECH DEVICE: THE PLAINTIFF HAS SUFFERED FROM PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF¿S MOBILITY AND QUALITY OF LIFE. PLAINTIFF WAS REQUIRED TO UNDERGO A REVISION SURGERY ALONG WITH THE RESULTANT PERIOD OF PAIN FOLLOWING SURGERY, RECUPERATION, REHABILITATION PERIOD AND PHYSICAL THERAPY. PLAINTIFF¿S ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES SUCH AS WALKING AND STANDING HAS BEEN CONSEQUENTLY LIMITED. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT

  Patient problems: Discomfort; Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 21162596 ↗
• InjuryJan 6, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED IN NOVEMBER 2022 THAT IN (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN EXACTECH DEVICE. IN (B)(6) 2020, A BONE SCAN REVEALED MILD TO MODERATE ACTIVITY IDENTIFIED ON BOTH SIDES OF THE PROSTHESIS. THE PATIENT WAS DIAGNOSED WITH RIGHT KNEE PAIN, UNSPECIFIED CHRONICITY. THUS, DUE TO WORSENING PAIN, INSTABILITY, SWELLING, LOST ABILITY TO EXERCISE, AND DISRUPTION IN ACTIVITIES OF DAILY LIVING, THE PATIENT UNDERWENT A RIGHT KNEE REPLACEMENT REVISION SURGERY IN (B)(6) 2020 AT TO REMOVE THE IMPLANTED DEVICE. DURING THE REVISION SURGERY, THE PATIENT'S ORTHOPEDIC SURGEON NOTED ¿LAXITY IN FLEXION¿ AND ¿FLEXION INSTABILITY¿. FURTHER REPORTED, THE PATIENT SUFFERED A PULMONARY EMBOLUS AFTER HER REVISION SURGERY, WAS SUBJECTED TO AN EXTENDED HOSPITAL STAY, AND WAS ADMINISTERED COUMADIN FOR 6 MONTHS POST-SURGERY WITH FREQUENT BLOOD DRAWS. THE PATIENT ALSO HAD TO HAVE EXTENDED PHYSICAL THERAPY FOR MONTHS AFTER HER REVISION SURGERY. IT WAS FURTHER REPORTED IN (B)(6) 2023, PATIENT EXPERIENCED FAILED RIGHT TKA SECONDARY TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND FLEXION INSTABILITY. THE SURGEON'S REPORT ALSO STATES ¿THERE WAS NO SIG

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

  MAUDE report 21087889 ↗
• InjuryJun 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 3 YEARS, 3 MONTHS LATER THE PATIENT WAS REVISED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, POLYETHYLENE WEAR, OSTEOLYSIS, SYNOVITIS, IMPLANT-INTERFACE DEBONDING, GENICULATE ARTERY EMBOLIZATION, PATELLAR LATERAL FACETECTOMY. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19574975 ↗
• InjuryMay 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL RIGHT TSA, THE 56 Y/O FEMALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A REVISION DUE TO LOOSE FEMUR AND RECALLED POLY. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGE AND X-RAY RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE RECALL IMPLANTS.

  Patient problems: Failure of Implant; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 19355604 ↗
• InjuryJan 23, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TKA, THE 61 Y/O FEMALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A REVISION DUE TO LOOSE FEMUR AND RECALLED POLY. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS NOT REVISED TO EXACTECH DEVICES DUE TO RECALL SURGEON USED COMPETITOR FOR REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE RECALL DEVICES.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Emotional Changes; Failure of Implant; Implant Pain; Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 18563759 ↗
• InjuryDec 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT TKA, THE 60 Y/O MALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A LOOSE FEMUR AND RECALLED POLY. PATIENT WAS REVISED TO COMPETITOR'S DEVICES DUE TO RECALL AND SURGEON PREFERENCE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE DEVICES.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18331139 ↗
• InjuryDec 6, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2019. APPROXIMATELY 4 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY. 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 WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Implant Pain; Joint effusion

  MAUDE report 18276520 ↗
• InjuryMar 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 66 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 4 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN. LOOSE FEMUR INDICATED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED. CHAIN OF COMMAND - DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Failure of Implant; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 16492042 ↗