Truliant 02-020-11-0350Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862314581), received between May 18, 2021 and May 19, 2026 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

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

  REPORT #2 OF 2 FOR THIS EVENT. IT WAS REPORTED THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, TWO (2) YEARS LATER THE PATIENT BEGAN TO EXPERIENCE SIGNIFICANT PAIN WITH THE RIGHT KNEE, WAS UNABLE TO WALK, PAIN WITH WEIGHTBEARING AND FLEXION CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE. A REVISION OPERATIVE REPORT WAS PROVIDED. PRE AND POST OPERATIVE DIAGNOSIS' WERE RIGHT PROSTHETIC FLEXION CONTRACTURE AND DEBONDING OF THE FEMORAL COMPONENT. INTRAOPERATIVELY, OSTEOPOROSIS WAS OBSERVED. NO OBVIOUS WEAR TO THE TIBIAL INSERT BUT EASILY REMOVED. THE FEMORAL CANAL CEMENT WAS IN TACT, BUT THE FEMORAL COMPONENT WAS COMPLETELY DEBONDED FROM THE CEMENT. THE PATIENT WAS REVISED TO ANOTHER MANUFACTURER'S KNEE SYSTEM. THE PATIENT WAS THEN TRANSFERRED TO PACU IN STABLE CONDITION. ADDITIONALLY, IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT CONTINUES TO EXPERIENCE SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING AND BONE LOSS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Contracture; Osteolysis; Pain; Unspecified Musculoskeletal problem

  MAUDE report 25224783 ↗
• InjuryFeb 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 52 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, OSTEOLYSIS, PAIN, SCAR TISSUE, SWELLING/EDEMA, AND SYNOVITIS. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 21414165 ↗
• InjuryJan 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 24 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOARTHRITIS, LOOSE FEMORAL COMPONENT, AND BODY WEAR OF THE PATELLAR COMPONENT. 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 AND A LOOSE FEMORAL COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. UNABLE TO LOCATE PATIENT/SERIAL NUMBER IN EBI. SERIAL NUMBER PROVIDED. HISTORICAL RECORD AND SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. NO FURTHER INFORMATION. X-RAY: NO OPERATIVE NOTES: YES, CONCOMITANT DEVICES ARE UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21228787 ↗
• InjuryJan 15, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 61 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 2 YEARS 3 MONTHS POST THE INITIAL PROCEDURE AS THE PATIENT PRESENTED WITH INSTABILITY AND OSTEOLYSIS. THE SURGEON REVISED TO A SIZE 4 RIGHT CONDYLAR CONSTRAINED FEMUR WITH A 4/5MM DISTAL AUG LARGE 32 CONE AND 20X120 STEM. 4F/3T FIT TRAY WITH 32 CONE AND 16X80 STEM. 4/15MM CC INSERT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE IS RETURNING DUE TO THE PATIENT¿S LAWYER. ADDITIONAL INFORMATION RECEIVED FROM THE LEGAL DEPARTMENT - REVISION OPERATIVE REPORT OF (B)(6) 2022- INDICATION: THE PATIENT DEVELOPED PROGRESSIVE PAIN AND SWELLING IN THE RIGHT KNEE WITH DIFFICULTY AMBULATING. HE WAS FOUND TO HAVE PROGRESSIVE OSTEOLYSIS UNDER THE MEDIAL ASPECT OF THE TIBIAL COMPONENT. THERE WERE ALSO CONCERNS ABOUT LOOSENING OF THE FEMORAL COMPONENT WITH OSTEOLYSIS UNDER THE ANTERIOR FLANGE. THERE WERE NO CLINICAL SIGNS OF INFECTION. FINDINGS: MODERATE TO LARGE LUMP AMOUNT OF NORMAL-APPEARING JOINT FLUID. THE POLYETHYLENE LINER WAS MODERATELY WORN ON THE MEDIAL SIDE PRIMARILY WITH PITTING. THE FEMORAL COMPONENT WAS

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 21162274 ↗
• InjuryJul 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, SALES REP REACHED OUT TO MANUFACTURE ENGINEER TO INFORMED THAT SURGEON DID A REVISION OF A FEMORAL COMPONENT AND TIBIAL INSERT. ALSO ACCORDING TO SALES REP VERY SOON AFTER THE KNEE REPLACEMENT THE PATIENT UNDERWENT A SAME SIDE HIP FUSION WHERE THE HIP WAS FUSED WITH INTERNAL ROTATION. THE SURGEON BELIEVE THIS MAY HAVE LED TO COMPLICATIONS IN THE KNEE JOINT. SALES REP IS SENDING THE TIBIAL INSERT BACK AND PER DOCTOR¿S REQUEST FOR DEVICE ANALYSIS REVIEW. THE ORIGINAL DATE OF SURGERY ACCORDING TO SALES REP WAS (B)(6) 2020.

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

  MAUDE report 19757624 ↗
• InjuryApr 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 58 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 4 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY INDICATED. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THE EVENT WAS NOT RELATED TO A BREAKAGE OF DEVICE. THERE WERE NO SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PATIENT HISTORY OR COMORBIDITIES WERE REPORTED. NO X-RAYS WERE PROVIDED. A DEVICE IMAGE WAS PROVIDED. NO DEVICE RETURNS ANTICIPATED. DUE TO THE RECALL, THE HOSPITAL WILL NOT RELEASE IMPLANTS. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 16753149 ↗
• InjuryJan 3, 2023Adverse 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 BY THE LEGAL BRIEF, ON (B)(6) 2018, A MALE PATIENT UNDERWENT A RIGHT TKR, OVER TIME, THE PATIENT BEGAN EXPERIENCING PAIN, SWELLING, INSTABILITY, AND AN INABILITY TO BEAR WEIGHT ON HIS RIGHT KNEE. ¿EVENTUALLY, THE SYMPTOMS BECAME SO SEVERE THAT HE WAS HAVING SIGNIFICANT DIFFICULTY AMBULATING.¿ ON (B)(6) 2020, PATIENT UNDERWENT REVISION. ¿DURING THE REVISION PROCEDURE, PATIENT¿S SURGEON NOTED DEFECTIVE EQUIPMENT REQUIRING COMPLETE REVISION.¿ NO ADDITIONAL INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16092587 ↗
• InjuryDec 30, 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 90 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT COMPLAINED OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL PATIENT INFORMATION REPORTED. DEVICES NOT RETURNING, HOSPITAL WILL NOT RELEASE.

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

  MAUDE report 16077004 ↗
• InjuryMay 3, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST INITIAL RIGHT TKA, THIS (B)(6) MALE PATIENT COMPLAINED OF PAIN AND LOSE FEMUR. THERE WAS NO BREAKAGE OF DEVICES OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO CHAIN OF CUSTODY BETWEEN HOSPITAL AND PATIENT; THEREFORE. SALES REP WAS UNABLE TO RETRIEVE IT.

  Patient problems: Failure of Implant

  MAUDE report 14272010 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FOUR MONTHS POST INITIAL RIGHT TKA, THIS (B)(6) Y/O MALE PATIENT HAD A REVISION FOR AN UNKNOWN REASON AND SURGEON WAS NOT SURE IF THE POLY WAS PART OF THE RECALL. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGE RECEIVED. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14118851 ↗
• InjuryMay 18, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 33 MONTHS POSTOP R TKA, THE (B)(6) Y/O MALE PATIENT COMPLAINED OF HAVING RIGHT LEG PAIN. FEMUR WAS LOOSE AND REVISED TO A CC REVISION KNEE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 11841182 ↗