Truliant 02-020-12-0240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862314802), received between Oct 18, 2021 and Aug 5, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS 58 YEAR OLD, MALE PATIENT HAD A LEFT INITIAL TKA ON (B)(6) 2020. THE PRESS FIT FEMORAL COMPONENT SHOWED LOOSE ON A BONE SCAN AND THE PATIENT WAS REVISED ON (B)(6)2022. THE PATIENT WAS REVISED TO A CONSTRAINED SIZE 4 LEFT SIDE AND A SIZE 4/13MM PS LINER WITH A 18X80 CEMENTED STEM. 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.

  Patient problems: Failure of Implant; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 15174864 ↗
• InjuryOct 18, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY TEN MONTHS POST INITIAL TKA, THIS MALE PATIENT HAD A REVISION FOR LOOSENING FEMORAL COMPONENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 12646985 ↗