Truliant 02-020-13-0315Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862320704), received between Jan 2, 2025 and Jan 2, 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 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. PATIENT EXPERIENCED PROSTHESIS WEAR, LOOSENING, IMPLANT PAIN AND JOINT LAXITY. PER THE OPERATIVE NOTES, "WE THEN SAW THAT THE FEMORAL COMPONENT WAS CLEARLY LOOSE." ADDITIONALLY, "WE REMOVED THE OLD PATELLAR COMPONENT, WHICH APPEARED TO BE WELL FUNCTIONING AND THEN PREPARED THE PATELLA FOR SIZE 35 MM COMPONENT." BASED ON WHAT WAS REPORTED IN THE OPERATIVE NOTES, IT DOES NOT APPEAR THAT THE PATELLAR COMPONENT WAS WORN; HOWEVER, THIS CANNOT BE CONFIRMED. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 21054876 ↗