Truliant 02-022-35-3510Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862304353), received between Oct 4, 2022 and Oct 28, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (8 reports).

2 FDA recall records name this device's identifier, 2 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. Nov 21, 2023Class IIOpen, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0585-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

2. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ARTHROFIBROSIS, STIFFNESS AND PAIN. AS A RESULT, APPROXIMATELY EIGHT MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Arthrofibrosis; Pain

  MAUDE report 23407270 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S LEFT TOTAL KNEE ARTHROPLASTY (TKA) WAS REVISED A WEEK POST INITIAL OPERATION. AFTER ABOUT A WEEK LATER FROM A PRIMARY SURGERY, HE TOOK X-RAYS FOR POST OPERATIVE OBSERVATION, AND FOUND OUT THAT THE TIBIAL INSERT WAS DISASSOCIATED AND MOVED TO ANTERIOR SIDE. SO HE DECIDED TO PERFORM REVISION SURGERY TO EXCHANGE TIBIAL INSERT FROM PS TYPE 10MM TO PSC TYPE 9MM BECAUSE A GAP BETWEEN FEMORAL AND TIBIAL COMPONENTS WAS TIGHT. ALSO, THIS PATIENT HAD ONE FALLING DOWN WITHIN THIS PERIOD. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21249225 ↗
• InjuryNov 1, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA *ORIGINAL DESCRIPTION SUMMARY* AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 2 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2020. 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. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD AND SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. UNABLE TO DETERMINE RIGHT AND LEFT PRODUCTS. THE PATIENT HAS FILED A COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. 2022 CA 002670. 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, O

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

  MAUDE report 20587502 ↗
• InjuryAug 20, 2024Naturally Worn; Naturally Worn

  (B)(4). IT WAS REPORTED THAT APPROXIMATELY 39 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20005208 ↗
• InjuryJul 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 3 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.

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

  MAUDE report 19805561 ↗
• InjuryJul 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 9 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SEVERE PAIN & SWELLING, DECREASED ROM,MENTAL ANGUISH, EMOTIONAL DISTRESS, FEAR, LOSS OF ENJOYMENT OF LIFE, HE WILL SUSTAIN FUTURE DAMAGES, MEDICAL CARE, REHAB, MENTAL AND EMOTIONAL DISTRESS AND PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19805287 ↗
• InjuryJun 27, 2024Structural Problem; Detachment of Device or Device Component; Naturally Worn; Structural Problem; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 33 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AND INSERT. PHOTOS PROVIDED SHOW SIGNS OF TIBIAL INSERT POLY WEAR. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. CHAIN OF COMMAND DUE TO RECALL, HOSPITAL WILL NOT RELEASE INDICATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19625654 ↗
• InjuryMay 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 49 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. THE PATIENT HAS REPORTED MENTAL AND EMOTIONAL DISTRESS FOR HAVING TO UNDERGO A REVISION SURGERY, REHABILITATION, PAST COST OF MEDICAL CARE, FUTURE COST OF MEDICAL CARE, AND LOSS OF EARNING CAPACITY. THE PATIENT ALSO REPORTED PAIN AND SUFFERING DUE TO THE FAILED IMPLANT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Failure of Implant; Implant Pain

  MAUDE report 19403889 ↗
• InjuryMar 20, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAS AN "UPCOMING PROCEDURE, SCHEDULED FOR (B)(6) 2024". IMPLANT DATE IS NOT REPORTED, DEVICES WERE NOT REPORTED, REASON FOR PENDING REVISION IS NOT REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Insufficient Information; Swelling/ Edema

  MAUDE report 18939586 ↗
• InjuryOct 10, 2023Material Discolored; Mechanical Problem; Unstable; Naturally Worn; Material Discolored; Mechanical Problem; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2021. APPROXIMATELY 2 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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. REVISION OP REPORT (B)(6) 2023. DIAGNOSIS: POLYETHYLENE INSERT OXIDATION, BEARING SURFACE WEAR AND PATELLAR CHONDROMALACIA GROSSLY LOOKING AT THE POLYETHYLENE INSERT DID NOT DEMONSTRATE CATASTROPHIC FAILURE OF THE INSERT. THERE DID APPEAR TO BE SOME MINIMAL SUBSURFACE OXIDATION WITH A SLIGHTLY YELLOW TINGED.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Loss of Range of Motion; Scar Tissue; Swelling/ Edema

  MAUDE report 17903474 ↗
• InjuryMay 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT (B)(6) 2019 AND WAS IMPLANTED WITH AN EXACTECH TRULIANT DEVICE. THEY HAVE SINCE REPORTED SYMPTOMS INCLUDING PAIN, STIFFNESS, AND IMPAIRED MOBILITY. THERE IS NO INFORMATION REGARDING HAVING OR PLANNING TO HAVE REVISION SURGERY. 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: Pain

  MAUDE report 16965252 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP THE INITIAL RIGHT TKA, THIS 67 Y/O FEMALE PATIENT WAS REVISED DUE THE RECALL. PATIENT HAD A LITTLE BIT OF DISCOMFORT BUT NO MAJOR PROBLEMS. SURGEON WENT AHEAD AND DID A LINER EXCHANGE AND A TELE EXCHANGE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETUNING, SURGEON DID NOT FEEL THEY NEEDED TO BE SENT BACK, THERE WAS NO SIGNIFICANT PROBLEMS WITH THE LINER.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 15536390 ↗