Truliant 02-020-11-0245Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862314468), received between Jan 6, 2022 and Feb 2, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K171045); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2026Unstable

  AS REPORTED, APPROXIMATELY 5 YEARS AND 3 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO INSTABILITY OF THE FEMUR. THE REVISION WAS SUPPOSED TO BE FEMUR ONLY, BUT DUE TO THE PATIENT HAVING A 4.5 FEMUR, EVERYTHING HAD TO BE EXPLANTED SO THAT A CONSTRAINED LINER COULD BE IMPLANTED. 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.

  Patient problems: Joint Laxity

  MAUDE report 24233779 ↗
• InjuryNov 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE: AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2018. THEY UNDERWENT LEFT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 4 YEARS 2 MONTHS AFTER THEIR INITIAL IMPLANTATION. POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE POLYETHYLENE DUE TO PREMATURE WEAR AND POLY RECALL, AS WELL AS OSTEOLYSIS OF THE LEFT FEMORAL COMPONENT. THERE WERE WELL-FIXED TIBIAL AND PATELLAR COMPONENTS. THERE WAS A LOOSE FEMORAL COMPONENT THAT WAS LOOSE FROM THE CEMENT MANTLE. THERE WAS MODERATE POLYETHYLENE WEAR VISIBLE AND PALPABLE WITHIN THE TIBIAL POLYETHYLENE. THERE WAS ALSO FOUND TO BE POLYETHYLENE DEBRIS ENCAPSULATED WITHIN THE SYNOVIUM. THE CEMENT MANTLE WAS FOUND TO REMAIN ON THE FEMUR AND THERE WAS NO CEMENT ADHERENT TO THE BACK SIDE OF THE FEMORAL COMPONENT. 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. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. NO FURTHER INFORMATION.

  Patient problems: Osteolysis

  MAUDE report 20698350 ↗
• InjuryNov 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YEARS AND 2 MONTHS POST INITIAL LEFT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT WAS REVISED TO A COMPETITOR PROSTHESIS DUE TO COMPLAINTS OF PAIN, LOOSE FEMUR, AND RECALLED INSERT AND PATELLA. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 20668053 ↗
• InjurySep 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 69 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PERSISTENT AND INCREASING SIZE OF THE EFFUSION WITH WEIGHTBEARING PAIN; OSTEOLYTIC DEBRIS, OXIDATED AND DELAMINATED PATELLA, ASEPTIC LOOSE FEMORAL. 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: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20168407 ↗
• InjurySep 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 62 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 5 YEARS 9 MONTHS POST OP. PAINT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: CHAIN OF COMMAND. DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20139446 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS PATIENTS LEFT KNEE HAD PREVIOUSLY HAD THE FEMUR REVISED DUE TO PAIN . A SIZE 4 CC WAS USED AND A 4.5 PS INSERT WAS IMPLANTED DESPITE MISMATCH WITH THE FEMUR DUE TO NOT WANTING TO REMOVE WELL FIXED TIBIA. IMPLANTS NOT AVAILABLE TO RETURN. NO FURTHER INFORMATION AVAILABLE. PATIENT LAST KNOWN TO BE IN STABLE CONDITION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15245269 ↗
• InjuryMar 26, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL LEFT TKA, THIS (B)(6) MALE PATIENT COMPLAINED OF PAIN. LOOSE FEMUR. THERE WAS NO BREAKAGE OF DEVICE 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 FOR HOSPITAL AND PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 13921308 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A MALE PATIENT IS GOING TO HAVE A REVISION FOR FAILED IMPLANTS AND THE ORIGINAL SURGERY WAS BACK IN 2019. PATIENT REVISION CONSIST OF FEMUR, CEMENTED FEMORAL STEM AND A POLY LINER. THE INDICATION FOR INITIAL TKA IS TO END-STAGE OSTEOARTHRITIS. THE REVISION IS SCHEDULED TENTATIVE IN (B)(6) 2022 DUE TO LEFT KNEE FEMORAL EFFUSION BETWEEN BONE AND IMPLANT. PATIENT¿S PERFORMS ADL¿S INDEPENDENTLY BUT WITH PAIN AND SWELLING. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 13184453 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171045. One submission often covers many models, so check the product and lot details in each record.

• Z-0585-2024 · Nov 21, 2023 · Open, Classified
  Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-
• Z-0023-2022 · Aug 30, 2021 · Open, Classified
  TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR