Truliant 02-022-45-4030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862305879), received between May 20, 2024 and Feb 25, 2025 — classified as 6 injuries.

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

• InjuryFeb 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED. TIBIA CONSTRUCT WAS LOOSE. PATIENT WAS REVISED TO A 4F/3T TIBIA COMPONENT WITH 10MM TIBIA AUGMENTS, 2MM OFFSET, 16 X 80MM SPLINED STEM AND A 4X17MM PS INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 21459442 ↗
• InjuryJan 28, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 51 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, DISCOMFORT, JOINT LAXITY, OSTEOLYSIS, PAIN, AND SWELLING/EDEMA. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21253221 ↗
• InjuryJan 13, 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 A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY AND THEN APPROXIMATELY 1 YEAR, 9 MONTHS LATER, THE PATIENT EXPERIENCED A REVISION SURGICAL PROCEDURE. THE PATIENT WAS REVISED TO A COMPETITOR'S DEVICES. REVISION OPERATIVE REPORT STATES- FAILED TKA SECONDARY SEPTIC LOOSENING. X-RAYS DEMONSTRATED LOOSENING OF TIBIAL AS WELL AS PATELLAR COMPONENT. ASPIRATED KNEE, IT WAS SIGNIFICANT FOR RED BLOOD CELLS AS WELL AS 12,000 WHITE BLOOD CELLS WITH 100% NEUTROPHIL DIFFERENTIAL- NOTHING GREW FROM THE ASPIRATION. PATELLAR COMPONENT WAS COMPLETELY LOOSE. REMOVED ANY REMAINING CEMENT. FEMORAL COMPONENT WAS GROSSLY LOOSE.... REMOVED THE TIBIAL COMPONENT, IT WAS GROSSLY LOOSE. NO APPARENT COMPLICATIONS NOTED. THERE IS NO CLINICAL/PATIENT MEDICAL INFORMATION PROVIDED. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Inadequate Osseointegration; Inflammation; Joint Laxity; Medical device site infection; Pain; Unspecified Infection

  MAUDE report 21143383 ↗
• InjurySep 30, 2024Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 24 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS TIBIAL BASEPLATE LOOSENING. NO IMAGES, X-RAYS, OR REVISION OPERATIVE NOTES WERE PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20334569 ↗
• InjurySep 30, 2024Fracture; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Unstable; 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 SECOND REVISION PROCEDURE TO ADDRESS RECURRENT TIBIAL LOOSENING AND PROGRESSIVE LEFT KNEE AND LEG COMPLAINTS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PRE/POST OPERATIVE DIAGNOSES: FAILED LEFT TOTAL KNEE ARTHROPLASTY WITH RECURRENT TIBIAL BASEPLATE LOOSENING AND IMPENDING EPIPHYSEAL TIBIAL FRACTURE AND STEM TIP. ON EXAM UNDER ANESTHESIA, THE KNEE EXHIBITED MILD LAXITY TO VARUS AND VALGUS STRESS IN FULL EXTENSION, MID AND DEEP FLEXION, AND HAD A MILD VARUS ALIGNMENT NOTED ON VISUAL INSPECTION. OPERATIVE FINDINGS INDICATED THE SYNOVIAL LINING WAS MILDLY INFLAMED, HYPERTROPHIED, AND CONTAINED NUMEROUS BEAD LIKE PROJECTIONS CONSISTENT WITH PARTICLE DISEASE. THE POLY INSERT EXHIBITED MINIMAL EVIDENCE OF POLY WEAR. THE FEMORAL COMPONENT WAS FOUND TO BE WELL FIXED TO BONE WITH ANDERSON TYPE I DISTAL FEMORAL BONE LOSS. THE TIBIAL BASE PLATE WAS LOOSE. THE TIBIA EXHIBITED ANDERSON II-A MEDIAL AND CENTRAL BONE LOSS. THE PATELLAR BUTTON EXHIBITED SIGNIFICANT WEAR, THINNING, AND DELAMINATION. THE SURGEON PERFORMED A REVISION LEFT TOTAL KNEE ARTHROPLASTY USING A COMPETITOR¿

  Patient problems: Bone Fracture(s); Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 20334339 ↗
• InjuryMay 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 32 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, MILD EROSION OF THE MEDIAL FEMORAL CONDYLE AND MILD SYNOVITIS. 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. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Erosion; Failure of Implant; Pain; Synovitis

  MAUDE report 19352680 ↗