Truliant 02-011-06-1130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862521934), received between Mar 21, 2023 and Mar 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionMar 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A DIFFICULT PRIMARY KNEE, WHILE TRIALING WITH A SIZE 3 CC LOGIC FEMORAL COMPONENT, DURING IMPACTION, THE TRIAL SUFFERED FROM METAL FATIGUE. IT WAS IMPACTED ONTO THE DISTAL FEMUR AND THE POSTERIOR CONDYLE PORTION OF THE TRIAL SNAPPED. NO PARTS OR PIECED FELL INTO THE WOUND SITE. THE SURGEON USED THE LOGIC SIZE 3 FEMORAL TRIAL TO CONTINUE THE OPERATION AND TRIALING. THERE WAS A 5-15 MINUTE SURGICAL DELAY WITH NO ADVERSE EFFECT TO THE PATIENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588192 ↗