Truliant 02-020-11-0230Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862314437), received between Oct 14, 2019 and Jan 17, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 13 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING AND 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: Pain

  MAUDE report 21179359 ↗
• InjuryDec 13, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

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

  MAUDE report 20926286 ↗
• InjuryMay 13, 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 LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, PAIN, STIFFNESS, SWELLING, DISCOMFORT, WEAKNESS AND INSTABILITY.

  Patient problems: Aseptic loosening; Discomfort; Failure of Implant; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 19296909 ↗
• InjuryMay 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 66 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 4 YEARS AND 11 MONTHS POST OP. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY. DUE TO RECALL SURGEON USED COMPETITOR FOR REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Cyst(s); Failure of Implant; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19244002 ↗
• InjuryOct 30, 2023Loosening 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 ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT 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 ON (B)(6) 2023. DIAGNOSIS: FAILED LEFT TOTAL KNEE DUE TO PREMATURE POLY WEAR AND OSTEOLYSIS. THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS A GROSSLY LOOSE FEMORAL COMPONENT WITH NO ADHERENT BACK SIDE CEMENT. THERE WAS A SEVERE AMOUNT OF OSTEOLYSIS ON THE DISTAL FEMUR. THERE WAS A PARTIALLY LOOSE TIBIAL COMPONENT WITH A MODERATE AMOUNT OF PROXIMAL TIBIAL OSTEOLYSIS. THERE WAS A WELL-FIXED PATELLAR COMPONENT. THERE WAS A SEVERE AMOUNT OF EXTRANEOUS SYNOVIAL TISSUE AND COMPLETE SYNOVECTOMY WAS PERFORMED. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Osteolysis; Pain

  MAUDE report 18031060 ↗
• InjuryAug 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL BILATERAL TKA, THE 55 Y/O FEMALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A LEFT KNEE REVISION DUE TO RECALLED POLY AND LOOSE FEMUR. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE RECALLED IMPLANTS.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17585723 ↗
• 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 LEFT 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; Inflammation; Joint effusion; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 16686905 ↗
• InjuryMar 1, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP THE INITIAL LEFT TKA, THIS 56 Y/O FEMALE PATIENT WAS REVISED DUE A LOOSE FEMUR. PATIENT COMPLAINT OF PAIN. POLY IS PART OF THE RECALL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 16463431 ↗
• InjurySep 16, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 60 YO MALE PATIENT, WHO WAS HAD AN INITIAL LEFT KNEE REPLACEMENT ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 4 YEARS 5 MONTHS POST THE INITIAL IMPLANT PROCEDURE. THE SURGEON REVISED A SIZE 3 LEFT FEMUR WHICH WAS LOOSE AND PS SIZE 3/9MM INSERT TO A LEFT SIZE 3 CONSTRAINED CONDYLAR FEMUR WITH A 14X120 STEM AND A CONSTRAINED SIZE 3/9MM INSERT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WERE NOT ABLE TO BE OBTAINED BY THE REP FOR RETURN.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Muscle Weakness/Atrophy; No Clinical Signs, Symptoms or Conditions; Pain; Unspecified Musculoskeletal problem

  MAUDE report 15438038 ↗
• InjuryJul 26, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS 68 YEAR OLD, FEMALE PATIENT HAD A TKA ON (B)(6) 2021. THE PATIENT WAS COMPLAINING OF PAIN AND WAS REVISED ON (B)(6) 2022 DUE TO A LOOSE FEMORAL COMPONENT. THERE IS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE DEVICES ARE NOT RETURNING.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15105049 ↗
• InjuryApr 26, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, A (B)(6) Y/O FEMALE PATIENT'S DURING INITIAL IMPLANT, AN INTRA-OPERATIVE LOOSENING OF THE FEMORAL COMPONENT WAS EXPERIENCED. THE FEMORAL AND TIBIAL COMPONENT WERE INITIALLY THE SAME SIZE. HOWEVER, THE FEMORAL COMPONENT WAS LOOSENING BUT THE TIBIAL COMPONENT WAS FIXED WELL. THEREFORE, THE SURGEON DOWNSIZED FROM A SIZE 3 TO A 2.5 DURING THE SURGERY. THE SURGEON FELT THE FLEXION GAP SHOULD BE EXPANDED AT THAT TIME AND USED THE FEMORAL COMPONENT SIZE (2.5 SIZE) AS A DOWNSIZING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 11729414 ↗
• InjuryOct 14, 2019Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT COMPLAINED OF PAIN. THE SURGEON PLANNED TO DO A SYNEVECTOMY AND POLY SWAP TO ADDRESS PATIENT COMPLAINT OF PAIN. FOLLOWING SYNEVECTOMY AND REMOVAL OF POLY THE SURGEON UTILIZED A BONE TAMP TO ENSURE THE IMPLANTS WERE STABLE. THE FEMORAL COMPONENT WAS LOOSE AND CAME OFF EASILY WITH NO CEMENT ADHESION TO THE PROSTHESIS. FOLLOWING REMOVAL, CEMENT WAS REMOVED FROM DISTAL FEMUR. THE FEMUR WAS THEN PREPARED UTILIZING TRADITIONAL INSTRUMENTATION (DISTAL CLEAN UP CUT, 4 IN 1 BLOCK, TRIAL PLACED, AND PS BOX PREPARED). A PRIMARY SIZE 3 FEMORAL COMPONENT WAS THEN IMPLANTED UTILIZING PALACOS CEMENT. THE PATIENT LEFT THE OPERATING ROOM WITH A WELL-BALANCED TOTAL KNEE REPLACEMENT.

  Patient problems: Pain

  MAUDE report 9185113 ↗