Truliant 02-020-12-0250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862314826), received between Feb 28, 2022 and Feb 28, 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.

• InjuryFeb 28, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL LEFT SIDE TKA, THIS MALE PATIENT WAS BROUGHT BACK WITH LEFT KNEE STARTUP PAIN. THE POLY WAS REMOVED. THE FEMUR WAS CHECKED AND FOUND TO BE LOOSE. THE TIBIA WELL FIXED. THE PATIENT WAS REVISED WITH A SIZE 5 LOGIC CC FEMUR WITH A 24X120 STEM, A 2MM OFFSET COUPLER, AND A SIZE 5 15MM INSERT. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS OR X-RAYS. THE DEVICES WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 13623251 ↗