Truliant 02-020-11-0220Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862314413), received between Mar 18, 2020 and Apr 4, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2010. THE PATIENT HAD A RECALLED IMPLANT AND WAS REVISED ON (B)(6) 2023. 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. THIS IS 1 OF 2 REPORTS FOR THIS EVENT. SEE MDR # 1038671-2023-02850.

  Patient problems: Insufficient Information

  MAUDE report 21777091 ↗
• InjuryMar 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 43 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, LOOSE FEMORAL COMPONENT, SYNOVITIS, OSTEOLYSIS, PAIN, AND INSTABILITY. 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: Implant Pain; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 21525392 ↗
• InjuryJan 23, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 45 MONTHS AFTER A TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING. 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 21217455 ↗
• InjurySep 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 67 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, BILATERAL KNEE PAIN; SEVERE OSTEOLYSIS; SIGNIFICANT WEAR ON THE POLYETHYLENE INSERT, HAVING WORN THROUGH ON THE POSTERIOR MEDIAL ASPECT, INCLUDING PITTING AND DELAMINATION; DEBONDING OF FEMORAL, SIGNIFICANT BACKSIDE WEAR OF THE PATELLA. 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: Implant Pain; Osteolysis; Synovitis

  MAUDE report 20249471 ↗
• InjuryJul 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 3 YEARS 4 MONTHS POST OP. DURING SURGERY THE SURGEON REALIZED THE FEMORAL COMPONENT WAS GROSSLY LOOSE AND FELL RIGHT OFF LEAVING A PERFECT CEMENT MANTLE ON THE BONE. SURGEON REVISED THE FEMUR TO A LOGIC CC FEMUR, ADDED A 14 X80 STEM EXTENSION AND INSERTED A NEW 2 X 10 PS POLY. NO FRAGMENTS, PARTS OR PIECES FELL INTO THE PATIENT. THE FRAGMENTS, PARTS OR PIECES WERE REMOVED FROM THE PATIENT. NO PARTS OR PIECES OF THE DEVICE FELL INTO THE PATIENT WOUND SITE. REPORTED EVENT LED TO >45 MINUTE SURGICAL DELAY/PROLONGATION. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE SURGICAL DELAY/PROLONGATION. PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE. X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 19645519 ↗
• InjurySep 11, 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) 2019. THE PATIENT PRESENTED HAD ASEPTIC FEMORAL LOOSENING AND RECALLED POLYETHYLENE INSERT; REVISION L TKA SCHEDULED THE PATIENT WAS REVISED (B)(6) 2022. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO DEVICE, DEFINITELY RELATED TO PROCEDURE. OUTCOME: RESOLUTION DATE: (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 17718692 ↗
• InjuryJun 9, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4.6 YEARS POST INITIAL LEFT TKA, THE 56 Y/O FEMALE PATIENT COMPLAINT OF PAIN. PATIENT HAD A REVISION DUE TO LOOSE FEMUR AND RECALLED POLY. DUE TO RECALL SURGEON USED COMPETITOR 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 IMAGE RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE O RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Aseptic loosening; Failure of Implant; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17101016 ↗
• InjuryMar 18, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT APPROXIMATELY 1.5 YEARS POSTOP THE INITIAL IMPLANT COMPLAINED OF PAIN. A BONE SCAN WAS PERFORMED WHICH DETERMINED THAT THE FEMORAL COMPONENT WAS LOOSE. DURING THE REVISION, THE FEMORAL COMPONENT WAS REMOVED BY HAND WITH NO CEMENT ADHERED TO THE FEMORAL COMPONENT. THE POLY INSERT CLEARLY SHOWED PITTING. ALSO, OSTEOLYSIS WAS PRESENT IN THE FEMUR. REVISED THE FEMUR WITH A SIZE 2 CC FEMORAL COMPONENT WITH AN OFFSET AND 40MM CEMENTED STEM. THE POLY WAS ALSO REPLACED WITH A 2 X 13MM PS INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WERE DISPOSED OF BY THE FACILITY.

  Patient problems: Failure of Implant

  MAUDE report 9848979 ↗