NA 02-029-19-1300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862577917), received between Mar 5, 2021 and Mar 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K170240, K171045, K181794); 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.

• MalfunctionMar 5, 2021Break; Break

  AS REPORTED, WHILE IMPACTING THE TRIAL PS FEMUR, THE DISTAL TIP OF THE LOCKING ARM BROKE OFF. THIS PREVENTED THE LOCKING ARMS FROM BEING ABLE TO HOLD ON TO THE FEMORAL COMPONENT. THE BROKEN PIECE WAS LOCATED ON THE BED AND DISCARDED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11422316 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170240, K171045, K181794. 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