Truliant 02-022-45-3535Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862305855), received between Jan 15, 2025 and Jan 15, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ***ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 04-DEC-2023***. LEGAL CASE ¿ USA (MDL NO. 3044). PATIENT ID: (B)(6). RELATED (B)(4) LK REV. 15. PLAINTIFF WAS IMPLANTED WITH THE FOLLOWING EXACTECH DEVICE: TRULIANT. 16. LEG IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: RIGHT. 17. DATE THE EXACTECH DEVICE WAS IMPLANTED: (B)(6) 2018. 18. STATE IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: OH. 19. DATE THE EXACTECH DEVICE WAS SURGICALLY REMOVED/REVISED: (B)(6) 2022. 20. PLAINTIFF HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS AS A RESULT OF THIS EXACTECH DEVICE: THE PLAINTIFF HAS SUFFERED FROM PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF¿S MOBILITY AND QUALITY OF LIFE. PLAINTIFF WAS REQUIRED TO UNDERGO A REVISION SURGERY ALONG WITH THE RESULTANT PERIOD OF PAIN FOLLOWING SURGERY, RECUPERATION, REHABILITATION PERIOD AND PHYSICAL THERAPY. PLAINTIFF¿S ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES SUCH AS WALKING AND STANDING HAS BEEN CONSEQUENTLY LIMITED. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN

  Patient problems: Discomfort; Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 21162432 ↗