Truliant 02-020-11-0330Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862314543), received between Sep 21, 2020 and Mar 12, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (12 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.

• InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP INITIAL RIGHT TKA, THIS 67 Y/O FEMALE PATIENT WAS REVISED. PATIENT HAD RECALLED LINER AND LOOSE FEMUR. SURGEON REPLACED FEMUR AND POLY. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21587206 ↗
• InjuryDec 31, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 27 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, INSTABILITY, SYNOVITIS, FAILURE OF IMPLANT, IMPLANT PAIN, JOINT LAXITY, AND JOINT EFFUSION. 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: Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Synovitis

  MAUDE report 21049153 ↗
• InjuryAug 28, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 49 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, DEBONDED FEMORAL. 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: Insufficient Information

  MAUDE report 20084686 ↗
• InjuryAug 22, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, SWELLING, DISCOMFORT, WEAKNESS AND INSTABILITY. POST OPERATIVE DIAGNOSIS NOTED WEAR AND LOOSENING OF THE IMPLANT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 20025076 ↗
• InjuryAug 16, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL RIGHT SIDE TKA, THE 55 Y/O FEMALE PATIENT COMPLAINT OF PAIN AND HAD A REVISION DUE TO RECALLED POLY AND LOOSE FEMUR. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS AND X-RAY RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE IMPLANTS.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17561592 ↗
• InjuryJul 12, 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 67 Y/O FEMALE PATIENT CAME IN DUE TO THE TIBIAL INSERT RECALL. PATIENT HAD A REVISION DUE TO RECALL AND THE FEMUR WAS LOOSE. PATIENT WAS REVISED FROM A SIZE 3 FEMUR AND A RECALL TIBIAL INSERT TO A SIZE 3 CONSTRAINED FEMUR WITH A PS SIZE 15 MM TIBIAL INSERT AND A STEM EXTENSION. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17305544 ↗
• InjuryJun 15, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2020. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED ON (B)(6) 2023 DUE TO A LOOSE FEMUR AND RECALLED POLY. 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: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 17135306 ↗
• InjuryJun 14, 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) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN. A LOOSE FEMUR AND RECALLED POLY WERE INDICATED FOR THE REVISION PROCEDURE. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED, DUE THE RECALL, THE HOSPITAL WILL NOT RELEASE THEM. AN X-RAY AND DEVICE IMAGES WERE PROVIDED. NO ADDITIONAL PATIENT DETAILS OR HISTORY PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 17126330 ↗
• InjuryApr 5, 2023Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE FEMALE PATIENT HAD AN INITIAL BILATERAL TKA ON (B)(6) 2019. THE PATIENT COMPLAINED OF PAIN AND HER RIGHT KNEE WAS REVISED ON (B)(6) 2023 DUE TO LOOSE FEMUR AND RECALLED POLY. THIS EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE AND THERE IS NO REPORTED 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; Joint effusion; Pain; Synovitis

  MAUDE report 16686919 ↗
• InjuryDec 6, 2022Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY 3.5 YEARS POST INITIAL TKA, THE 56 Y/O FEMALE PATIENT HAD A REVISION DUE TO POLYETHYLENE WEAR AND FEMORAL LOOSENING.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Joint effusion; Pain

  MAUDE report 15927516 ↗
• InjuryAug 8, 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, THE 66 Y/O FEMALE PATIENT COMPLAINED OF PAIN AND LOOSE FEMUR. THERE WAS NO BREAKAGE OF A DEVICE AND SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTO RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE HOSPITAL WILL NOT RELEASE THE IMPLANTS.

  Patient problems: Aseptic loosening; Failure of Implant; Pain

  MAUDE report 15187681 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY 3 YEARS POST INITIAL LEFT TKA, THIS FEMALE PATIENT IS ASKING TO BE COMPENSATED FOR PAIN AND SUFFERING. THERE IS NO INDICATION OF REVISION ON EITHER SIDE TO DATE.

  Patient problems: Pain

  MAUDE report 13998386 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS IS THE (B)(6) Y/O FEMALE PATIENT¿S MOST RECENT REVISION OCCURRING APPROXIMATELY 8 MONTHS POST THE FEMORAL REVISION. THIS IS THE 2ND FEMORAL REVISION DUE TO LOOSENING AND LACK OF MOTION AND PAIN.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 10560496 ↗