Truliant 02-020-11-0225Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862314420), received between Oct 26, 2021 and Mar 31, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE ON A LEFT TKA, A POLY-TO-TIBIAL TRAY MISMATCH WAS LEFT UNCORRECTED: A SIZE 2 CC POLY WITH A 2.5F/3T TIBIAL TRAY. DURING THE REVISION, A 2.5F/3T TIBIAL TRAY WAS IMPLANTED WITH A 14MM O.D. X 25MM LENGTH STEM, WITH THE PLAN FOR A LEFT 2.5 PS FEMORAL COMPONENT. AFTER THE TIBIA WAS CEMENTED, THE FEMORAL COMPONENT WAS IMPLANTED WITH CEMENT. AFTER HOLDING THE FEMORAL COMPONENT TO THE FEMUR FOR ROUGHLY 10 MINUTES TO ENSURE THE CEMENT HAD SET, HE LET GO AND REALIZED THE FEMORAL COMPONENT WAS NOT STAYING. THE SURGEON DECIDED TO GO TO A CC FEMUR WITH A STEM. A SIZE 2 CC FEMUR WITH A 17MM CC TIBIAL INSERT. THEY CEMENTED A LEFT SIZE 2 CC FEMUR WITH A 14 MM O.D. X 120MM LENGTH STEM. THEY THEN INSERTED THE 17MM CC TIBIAL INSERT AND REALIZED A LARGER INSERT WAS NEEDED, THUS REMOVING AND INSERTING A 21MM CC TIBIAL INSERT WITH THE LOCKING SCREW GOING THROUGH THE TIBIAL INSERT, THE TIBIAL TRAY, AND THE STEM. THE FINAL CONSTRUCT IMPLANTED IN THE PATIENT WAS A LEFT SIZE 2 CC FEMORAL COMPONENT WITH A 14 MM O.D. X 120MM LENGTH STEM ON THE FEMORAL SIDE. ON THE TIBIAL SIZE, THERE IS SIZE 2 21MM CC TIBIAL INSERT WITH A SIZE 2.5F/3T TIBIAL TRAY, AND A 14MM O.D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747839 ↗
• InjuryMar 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY 88 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT SURGERY, THE PATIENT EXPERIENCED PAIN AND UNDERWENT REVISION SURGICAL PROCEDURE. THE SURGEON REPORTED LOOSE FEMUR AND RECALLED POLYETHYLENE WEAR AND PROVIDED POST-SURGICAL IMAGE. NO REVISION OPERATIVE REPORT WAS PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 21559610 ↗
• InjuryJan 8, 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 59 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PAIN, SWELLING/ EDEMA, BONE FRACTURE(S), EMOTIONAL CHANGES, AMBULATION OR POSTURAL DIFFICULTIES, JOINT EFFUSION AND JOINT LAXITY. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. REVISION OPERATIVE REPORT OF 28 DEC 2022- REVISED TO COMPETITOR¿S DEVICES. POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO A RECALLED POLYETHYLENE INSERT AND FEMORAL LOOSENING. RADIOGRAPHS SHOWED A POSSIBLE RADIOLUCENCY DEVELOPING UNDER THE FEMORAL COMPONENT. INFECTION WORKUP WAS NEGATIVE. PROCEDURE: THERE WAS SYNOVITIS WITH BROWN STAINING OF THE SYNOVIAL TISSUE AND PARTICULATE DEBRIS DEPOSITED IN THE MEDIAL AND LATERAL GUTTERS. THE PATELLAR BUTTON WAS WELL FIXED AND IN GOOD CONDITION, IT WAS RETAINED. THERE WAS NO GROSS WEAR OR DAMAGE TO THE POLYETHYLENE. THE PATIENT WAS AWOKEN FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY 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; Bone Fracture(s); Emotional Changes; Joint Laxity; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 21106419 ↗
• InjuryDec 12, 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 38 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS INCREASED SWELLING, PAIN, INSTABILITY AND PROSTHESIS WEAR/LOOSENING. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE FINDINGS NOTED FAILED LEFT TOTAL KNEE SECONDARY TO POLYETHYLENE WEAR AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. INTRAOPERATIVELY, THE SURGEON OBSERVED NO SIGNS OF INFECTION OR PURULENCE. SYNOVITIS, SCAR TISSUE AND EARLY WEAR OF THE PATELLAR BUTTON AND A LOOSE FEMORAL COMPONENT WERE NOTED. THESE COMPONENTS WERE REMOVED WITH MINIMAL BONE LOSS. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20913973 ↗
• InjuryJun 9, 2023Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL LEFT TKA, THE 55 Y/O FEMALE PATIENT COMPLAINT OF PAIN. PATIENT HAD A REVISION DUE TO LOOSE FEMUR AND RECALLED POLY. DUE TO RECALL SURGEON USED COMPETITOR DEVICES FOR REVISION. 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 DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE IMPLANTS.

  Patient problems: Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 17100576 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY ONE-YEAR POST TKA, THE PATIENT COMPLAINT OF PAIN PATELLAR REGION AND GRINDING WHEN BENDS KNEE ON (B)(6) 2021. LEFT KNEE ARTHROSCOPIC SYNOVECTOMY FOR LEFT KNEE PATELLAR CLUNK ON (B)(6) 2021. THE EVENT IS UNLIKELY RELATED TO THE DEVICE BUT RELATED TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 12701361 ↗