Truliant 02-022-45-3020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862305817), received between Jul 22, 2022 and Jul 22, 2022 — 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.

• InjuryJul 22, 2022Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S TKA WAS REVISED DUE TO PAIN AND SYNOVITIS. TIBIAL COMPONENT WAS FOUND LOOSE. PATIENT LEFT IN STABLE CONDITION WITH A NEW TIBIA IMPLANTED WITH STEMS AND AUGMENTS, AND NEW 13MM PSC INSERT.

  Patient problems: Aseptic loosening; Failure of Implant; Pain; Synovitis

  MAUDE report 15087702 ↗