Truliant 02-020-11-0325Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862314536), received between Jun 23, 2021 and Mar 11, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2025Unstable; 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 17 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FEMORAL LOOSENING, INSTABILITY, PAIN, DISCOMFORT, SWELLING, STIFFNESS, GRINDING AND/OR POPPING OF THE KNEE, INABILITY TO BEAR WEIGHT, BUCKLING, AND GAIT IMPAIRMENT. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. FINDINGS ALSO INDICATED SYNOVITIS WITH PARTICULATE DEBRIS CONSISTENT WITH EARLY POLYETHYLENE WEAR VERSUS CEMENT DISEASE AND SCAR TISSUE AROUND THE PATELLA BUTTON. THE SURGEON PERFORMED A REVISION OF THE FEMORAL AND TIBIAL COMPONENTS. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. 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; Discomfort; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 21574196 ↗
• InjuryJan 2, 2025Unstable; 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 38 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, INSTABILITY, SYNOVITIS, JOINT LAXITY, SWELLING/ EDEMA, IMPLANT PAIN, AND MUSCLE WEAKNESS/ATROPHY. INITIAL SURGERY AND 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: Implant Pain; Joint Laxity; Muscle Weakness/Atrophy; Swelling/ Edema; Synovitis

  MAUDE report 21055748 ↗
• InjuryDec 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY. THE PATIENT CLAIMS THEY MAY NEED REVISION SURGERY, NO SCHEDULED SURGERY HAS BEEN REPORTED. 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: Failure of Implant; Joint effusion; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 21026807 ↗
• InjuryOct 21, 2024Loosening 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, PAIN IN RIGHT KNEE AFTER PRIMARY TOTAL KNEE ARTHROPLASTY AND OSTEOLYSIS. 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: Failure of Implant; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 20492362 ↗
• InjuryAug 22, 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 42 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PAIN, STIFFNESS, SWELLING, DISCOMFORT, AND INSTABILITY. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED FAILED RIGHT TOTAL KNEE ARTHROPLASTY DUE TO PREMATURE POLY WEAR AND POLY RECALL WITH OSTEOLYSIS. OPERATIVE FINDINGS: THERE WAS FOUND TO BE A CLEAN WOULD WITH CLEAR SYNOVIAL FLUID. THERE WERE PARTIALLY LOOSE FEMORAL AND TIBIAL COMPONENTS WITH A MILD AMOUNT OF OSTEOLYSIS BEHIND THE COMPONENTS. THERE WAS NO CEMENT ADHERENT TO THE FEMORAL COMPONENT WITH ALL CEMENT REMAINING ON THE DISTAL FEMUR. THERE WAS A MILD AMOUNT OF OSTEOLYSIS UNDERNEATH THE CEMENT MANTLE. THERE WAS A MINIMAL AMOUNT OF BONE LOSS WITH 5 ML OF MONTAGE BONE GRAFT FILLER REQUIRED TO FILL THE BONY DEFECTS WITHIN THE FEMORAL CONDYLES. THERE WAS FOUND TO BE A WELL-FIXED PATELLAR COMPONENT. THERE WAS MILD VISIBLE AND PALPABLE POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE COMPONENT. THERE WAS ENCAPSULATED POLYETHYLENE DEBRIS WITHIN THE SYNOVIUM AND A COMPLETE SYNOVECTOMY WAS PERFORMED. THE COMPONENTS

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

  MAUDE report 20040036 ↗
• InjuryJun 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 55 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SEVERE POLY WEAR ON THE ARTICULAR SURFACE, FEMORAL COMPONENT WAS LOOSE AND DEBONDED FROM THE CEMENT, PATELLAR COMPONENT HAD MILD WEAR. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19566065 ↗
• InjuryAug 31, 2023Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2021. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 2 YEARS 2 MONTHS POST PRIMARY PROCEDURE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Insufficient Information

  MAUDE report 17665668 ↗
• InjuryMay 9, 2023Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2021. THE UNDERWENT A REVISION OF THE RIGHT FEMUR AND LINER ON (B)(6) 2023. THE PATIENT WAS REVISED TO A CC FEMUR, STEM, FEMORAL CONE AND TRANSITIONAL LINER. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16900035 ↗
• InjuryAug 31, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL RIGHT TKA, THIS 52 Y/O FEMALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT COMPLAINED OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Aseptic loosening; Failure of Implant; Pain

  MAUDE report 15326570 ↗
• InjuryJun 23, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 2 YRS POSTOP THE INITIAL TKA, THIS (B)(6) Y/O FEMALE PATIENT WAS REVISED FOR A LOOSE LEFT FEMORAL COMPONENT. THE FEMUR AND POLY WERE REMOVED AT TIME OF SURGERY. THE FEMORAL COMPONENT HAD NO CEMENT BONDING. SURGEON DETERMINED THERE WAS NO INFECTION AT TIME OF SURGERY AND DECLARED IT ASEPTIC LOOSENING. SURGEON REMOVED A 2.5 TRULIANT FEMUR, AND IMPLANTED A 2 CC WITH SHORT STEM, AND 2.5 PS INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 12053245 ↗