Truliant 02-020-11-0250Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10885862314475), received between Mar 30, 2021 and May 19, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY DUE TO ADVANCED DEGENERATIVE JOINT DISEASE, LEFT KNEE, VARUS DEFORMITY, FLEXION CONTRACTURE. THEY WERE SUBSEQUENTLY REVISED, APPROXIMATELY 3 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT STATES THAT THE PATIENT INDICATED FOR SURGERY DUE TO PAIN, INSTABILITY, AND SWELLING. THE REPORT FURTHER STATES THAT THE LOOSENING OF THE FEMORAL COMPONENT WAS NOTED. FEMORAL COMPONENT HAD NO FIXATION TO THE CEMENT, BUT CEMENT HAD A GOOD FIXATION TO-THE BONE. 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; Discomfort; Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 25217291 ↗
• InjuryFeb 19, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST OP THE INITIAL LEFT TKA, THIS MALE PATIENT WAS REVISED DUE TO PAIN. PATIENT HAD A LOOSE FEMUR AND RECALLED POLY. NO BREAKAGE OF DEVICE OR SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. X-RAY & PHOTO ARE ATTACHED. PRODUCT IS NOT RETURNING, DUE TO RECALL HOSPITAL WILL NOT RELEASE IMPLANTS.

  Patient problems: Joint effusion; Pain

  MAUDE report 24387769 ↗
• InjuryJan 3, 2025Loosening 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 LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 4 YEARS AND 11 MONTHS AFTER INITIAL IMPLANT. PATIENT EXPERIENCED PROSTHESIS WEAR, FEMORAL LOOSENING AND JOINT LAXITY. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 21067517 ↗
• InjuryJan 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS AS A RESULT OF THIS EXACTECH DEVICE: SWELLING, LOOSENESS, AND KNOCKING. IT IS ALSO STATED THAT THE PATIENT HAS A REVISION SCHEDULED, THERE IS NO INFORMATION PROVIDED THAT A REVISION HAS OCCURRED. 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 FROM LEGAL ON 31-JUL-2023*** AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY DUE TO DEGENERATIVE ARTHRITIS. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION SURGERY APPROXIMATELY 1 YEAR 6 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT FINDINGS: DEBONDING OF THE FEMORAL COMPONENT TO THE UNDERLYING CEMENT. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Inflammation; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21056468 ↗
• InjuryDec 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION A 60 Y/O MALE PATIENT HAD A LEFT KNEE REPLACEMENT. APPROXIMATELY 4 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION. 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: FAILED LEFT KNEE SECONDARY TO EARLY POLYETHYLENE WEAR AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. SIGNIFICANT SCAR TISSUE AND SYNOVITIS SEEN. PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Scar Tissue; Synovitis

  MAUDE report 21026187 ↗
• InjuryNov 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 35 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND INFECTION. 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: Medical device site infection

  MAUDE report 20652251 ↗
• InjuryOct 14, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL NOTIFICATIONS AND OTHER SOURCES, THAT A MALE PATIENT, WHO WAS INITIALLY IMPLANTED ON THE LEFT KNEE ON (B)(6) 2018, WAS SEEN IN THE CLINIC AND THEY ARE HAVING SYMPTOMS/PAIN/EFFUSIONS, INDICATING A REVISION SURGERY IS NECESSARY. A REVISION LTKA HAD BEEN SCHEDULED FOR (B)(6) 2022. THE REVISION OCCURRED. PRE-OP/POST-OP DIAGNOSES: FAILED LEFT TKA SECONDARY TO ASEPTIC FEMORAL LOOSENING. INDICATIONS: INCREASING EFFUSIONS AND WEIGHTBEARING PAIN WITH CLINICAL EVIDENCE OF A FEMORAL LOOSENING. PROCEDURE: THE PATELLA WAS WELL FIXED, LEFT IN PLACE. PREVIOUS 12 MM INSERT WAS REMOVED. THE FEMORAL WAS DISIMPACTED FROM INTACT CEMENT MANTLE. TIBIA WAS WELL FIXED, LEFT IN PLACE. PREVIOUS 12MM INSERT WAS REMOVED. THE FEMORAL WAS DISIMPACTED. TIBIA WAS WELL FIXED AND LEFT IN PLACE. THE PATIENT WAS REVISED TO EXACTECH DEVICES. NO COMPLICATIONS. PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION.

  Patient problems: Joint effusion; Pain

  MAUDE report 20444017 ↗
• InjuryJul 9, 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 32 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, INSTABILITY, LOOSENING, AND DISCOMFORT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Failure of Implant; Implant Pain; Joint Laxity

  MAUDE report 19701106 ↗
• InjuryJun 9, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL LEFT TKA, THIS 74 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY. PATIENT COMPLAINED OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

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

  MAUDE report 17097027 ↗
• InjuryMay 24, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP INITIAL LEFT TKA, THIS 72 Y/O FEMALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY. PATIENT ALSO COMPLAINED OF PAIN.

  Patient problems: Failure of Implant

  MAUDE report 16992283 ↗
• InjuryMar 16, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 65 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 3 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN. LOOSE FEMUR INDICATED. NO SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICES RETURNING DUE TO ¿CHAIN OF COMMAND.¿ DUE TO RECALL HOSPITAL WILL NOT RELEASE THE IMPLANTS.

  Patient problems: Pain

  MAUDE report 16557246 ↗
• InjuryFeb 27, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL LEFT SIDE TKA, THE 65 Y/O FEMALE PATIENT COMPLAINT OF PAIN. PATIENT HAD A REVISION DUE TO LOOSE FEMUR. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF THE DEVICE OR A SURGICAL DELAY/PROLONGATION. IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE RECALL IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 16443955 ↗
• InjuryJan 18, 2023Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA AN EXACTECH TRULIANT KNEE CLINICAL STUDY, THAT A 64 YO MALE PATIENT, INITIAL LEFT TKA ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 2 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. DATE OF ONSET, (B)(6) 2022. FEMORAL LOOSENING AND RECALLED POLY RESULTED IN THE REVISION OF THE FEMORAL AND TIBIAL COMPONENTS. OUTCOME INDICATES RESOLVED ON THE DATE OF THE PROCEDURE. NO DEVICES RETURNING DUE TO CLINICAL STUDY GUIDELINES. NO FURTHER INFORMATION.

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

  MAUDE report 16196124 ↗
• InjuryDec 13, 2022Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL LEFT TKA, THIS 69 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT COMPLAINED OF PAIN. DUE TO RECALL SURGEON USED COMPETITORS IMPLANTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Joint Laxity; Joint effusion; Pain; Scar Tissue; Synovitis

  MAUDE report 15968472 ↗
• InjuryNov 9, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP THE INITIAL LEFT TKA, THIS 63 Y/O MALE PATIENT WAS REVISED DUE TO AND A LOOSE FEMUR. PATIENT WAS COMPLAINING OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING, HOSPITAL WILL NOT RELEASE.

  Patient problems: Failure of Implant

  MAUDE report 15761173 ↗
• InjuryJun 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL LEFT TKA, THE (B)(6) MALE PATIENT COMPLAINED OF PAIN AND HAD A REVISION DUE TO LOOSE FEMUR. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTO RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION BECAUSE HOSPITAL IS NOT RELEASING THE IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 14599483 ↗
• InjuryMar 30, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 27 MONTHS POSTOP THE INITIAL TKA, THIS (B)(6) MALE PATIENT'S LEFT FEMUR WAS LOOSE AND WAS REVISED THE FEMUR TO CC FEMORAL COMPONENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO THE IMPLANTS WERE DISPOSED OF BY HOSPITAL STAFF BEFORE REP COULD OBTAIN THEM.

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

  MAUDE report 11593086 ↗