Truliant 02-020-13-0345Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862314703), received between May 30, 2022 and May 30, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K171045); they may or may not involve this specific model.

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.

• InjuryMay 30, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL RIGHT TKA, THE 73 Y/O MALE PATIENT COMPLAINED OF PAIN AND HAD A REVISION DUE TO LOOSE FEMUR. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTO RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL HAS DECIDED TO KEEP THE IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 14545121 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171045. One submission often covers many models, so check the product and lot details in each record.

• Z-0585-2024 · Nov 21, 2023 · Open, Classified
  Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-
• Z-0023-2022 · Aug 30, 2021 · Open, Classified
  TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR