Truliant 02-020-11-0340Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862314567), received between Sep 26, 2019 and Oct 21, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Unstable; Noise, Audible; Unstable; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED INSTABILITY, PAIN AND NOISE FROM THE KNEE. AS A RESULT, THE PATIENT UNDERWENT RIGHT KNEE REVISION OF THE FEMORAL COMPONENT APPROXIMATELY 7 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23354209 ↗
• InjuryMar 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANTS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 21538214 ↗
• InjuryJan 28, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 51 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, DISCOMFORT, JOINT LAXITY, OSTEOLYSIS, PAIN, AND SWELLING/EDEMA. INITIAL SURGERY AND REVISION 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21253152 ↗
• InjuryDec 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 60 MONTHS AFTER A RIGHT KNEE TOTAL REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, CHRONIC PAIN AND SWELLING. POST OPERATIVE REPORT WAS PROVIDED. INTRAOPERATIVELY, THE SURGEON OBSERVED POLYETHYLENE SYNOVITIS, SCAR TISSUE AND WEAR OF THE PATELLA BUTTON, WEAR OF THE POLYETHYLENE INSERT, LYSIS AROUND THE LATERAL CONDYLE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20894714 ↗
• InjuryDec 3, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 54 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, INSTABILITY, SCAR TISSUE, SYNOVITIS, FAILURE OF IMPLANT, JOINT LAXITY, SWELLING, AND IMPLANT PAIN. REVISION 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; Implant Pain; Joint Laxity; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20837038 ↗
• InjuryNov 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE APPROXIMATELY 60 MONTHS AFTER INITIAL IMPLANT. PREMATURE POLY WEAR AND ASEPTIC FEMORAL LOOSENING. 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: Implant Pain; Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 20780014 ↗
• InjuryNov 13, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 36 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ASEPTIC LOOSENING OF THE FEMORAL COMPONENT, INCREASED SWELLING AND INSTABILITY AFTER A FALL ONTO THE RIGHT KNEE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED LOOSENING OF THE FEMORAL COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 20673789 ↗
• InjuryOct 2, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS INITIALLY REPORTED VIA LEGAL NOTIFICATION THAT THE PATIENT HAD AN INITIAL PRIMARY RIGHT KNEE TOTAL ARTHROPLASTY SURGERY 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. ADDITIONAL INFORMATION RECEIVED -IT WAS REPORTED THAT THE PATIENT HAS COMPLAINED OF PAIN. THE PATIENT HAD A REVISION SURGICAL PROCEDURE ON (B)(6) 2023 FOR A LOOSE FEMUR AND RECALLED POLY APPROXIMATELY 3 YEARS, 4 MONTHS AFTER IMPLANT. THE PATIENT WAS REVISED TO EXACTECH DEVICES. REPORTED EVENT IS NOT RELATED TO BREAKAGE OF A DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS WERE PROVIDED. PRODUCT NOT RETURNING: CHAIN OF COMMAND. DUE TO RECALL HOSPITAL WILL NOT RELEASE. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17857300 ↗
• InjuryNov 22, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS FROM THE TRULIANT KNEE CLINICAL STUDY THAT A 56 YO MORBIDLY OBESE FEMALE HAD A RIGHT KNEE REPLACEMENT PROCEDURE 11 OCT 2018 WITH A REVISION IN (B)(6) 2022, DUE TO A BONE FRACTURE. ON (B)(6) 2018 [36 DAYS POST OP] THE PATIENT REPORTED A PERIPROSTHETIC FEMORAL SHAFT FRACTURE THAT RESULTED IN AN OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE WITH INTRAMEDULLARY NAIL OF THE FEMORAL SHAFT FRACTURE. THE EVENT WAS NOTED TO BE RESOLVED (B)(6) 2018. NO ADDITIONAL INFORMATION.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 15848560 ↗
• InjuryApr 26, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL RIGHT TKA, THIS (B)(6) MALE PATIENT HAD A REVISION DUE TO LOOSE FEMUR, PATIENT WAS COMPLAINING OF PAIN. THIS IMPLANT COULD BE PART OF RECALL. THE SURGEON USED ANOTHER COMPANIES IMPLANTS FOR THE REVISION. 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 PHOTOS/X-RAYS, THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14210045 ↗
• InjuryJul 7, 2021Migration; Migration

  AS REPORTED, SURGEON REVISED A TRULIANT FEMUR IMPLANTED IN (B)(6) 2019 AT UNIVERSITY (B)(6). THE FEMUR WAS SUBSIDED AND WAS EXPLANTED WITHOUT CEMENT ON THE BACKSIDE. THE SURGEON MENTIONED THIS IN THE OR. SURGEON IMPLANTED A CC FEMUR WITH PS BEARING AND 5MM DISTAL AUGMENT. PATIENT SHOULD RECOVER WELL AFTER REVISION KNEE.

  Patient problems: Failure of Implant

  MAUDE report 12130768 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 26 MONTHS AFTER A (B)(6) Y/O MALE PATIENT¿S INITIAL RIGHT TKA PROCEDURE, THE KNEE WAS REVISED FOR INSTABILITY. DURING THE REVISION, THE PATIENT¿S FEMORAL COMPONENT WAS FOUND GROSSLY LOOSE. THE COMPONENT WAS REMOVED AND THERE WAS NO CEMENT ADHESION WAS ON THE BACKSIDE OF THE FEMORAL COMPONENT. WE REVISED TO A SIZE 4 CC FEMUR WITH A 40MM CEMENTED STEM. THE PS POLY WAS INCREASED FROM A 9MM TO A 11MM PS INSERT. ALL OTHER COMPONENTS (TIBIA AND PATELLA) WERE STABLE. THE SURGEON HAD MENTIONED THAT THE PATIENT HAD RECENT FALL/IMPACT ON THE KNEE IN QUESTION. THE DATE OF THIS INCIDENT IS UNKNOWN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO RETURN.

  Patient problems: Failure of Implant

  MAUDE report 10551703 ↗
• InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE SURGEON REVISED THE RIGHT KNEE OF THIS 63 Y/O PATIENT DUE TO AN INFECTION. THE INDEX SURGERY WAS (B)(6) 2019. THE PATIENT WAS STABLE AS THEY LEFT THE OPERATING ROOM. THERE WAS NO DELAY TO THE SURGERY. THE REP WAS PRESENT AT THE TIME OF THE SURGERY. IN ACCORDANCE WITH HOSPITAL POLICY WE WILL NOT BE RETURNING THE EXPLANTS. PATIENT WEIGHT IS 80 LBS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION OR IS NOSOCOMIAL IN NATURE.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 9125846 ↗