Truliant 02-022-51-3017Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862307675), received between Mar 14, 2025 and Mar 14, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0023-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionMar 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE OF A RIGHT TKA, THE SURGEON WAS NOT ABLE TO LOCK THE POLYETHYLENE INSERT INTO PLACE IN THE APPROPRIATE FASHION. THERE WAS OBVIOUS LOOSENESS AND INSTABILITY ASSOCIATED WITH THE COMPONENT. IT DID NOT APPEAR THAT THERE WAS OBVIOUS DAMAGE TO THE LOCKING MECHANISM ALTHOUGH THE SURGEON SUSPECTED THIS WAS LIKELY THE CASE GIVEN THE NEAR COMPLETE WEAR THROUGH OF POLYETHYLENE POSTERIORLY. ANOTHER NEW POLYETHYLENE WAS BROUGHT TO THE FIELD AS WELL. AGAIN, THE SURGEON WAS NOT ABLE TO SECURE THIS INTO PLACE USING THE STANDARD LOCKING MECHANISM. GIVEN THE INABILITY TO SECURE THE POLY, PLANS CHANGED TO A COMPLETE REVISION. THE SURGEON CAREFULLY REMOVED THE FEMORAL AND TIBIAL COMPONENTS. TIBIA AND FEMUR WERE REAMED. FULLY CEMENTED STEMS FOR TIBIA AND FEMUR WERE SELECTED. THERE WAS SIGNIFICANT BONE LOSS CENTRALLY AND A CONE WAS PREPPED FOR LATER PLACEMENT. 10 MM POSTERIOR AUGMENTS USED LATERALLY. CEMENT RESTRICTORS USED IN BOTH FEMUR AND TIBIA. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS AVAILABLE. THEY WERE SENT TO THE LAB AND LEGAL DEPARTMENT AT THE HOSPIT

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

  MAUDE report 21609870 ↗
• MalfunctionMar 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE OF A RIGHT TKA, THE SURGEON WAS NOT ABLE TO LOCK THE POLYETHYLENE INSERT INTO PLACE IN THE APPROPRIATE FASHION. THERE WAS OBVIOUS LOOSENESS AND INSTABILITY ASSOCIATED WITH THE COMPONENT. IT DID NOT APPEAR THAT THERE WAS OBVIOUS DAMAGE TO THE LOCKING MECHANISM ALTHOUGH THE SURGEON SUSPECTED THIS WAS LIKELY THE CASE GIVEN THE NEAR COMPLETE WEAR THROUGH OF POLYETHYLENE POSTERIORLY. ANOTHER NEW POLYETHYLENE WAS BROUGHT TO THE FIELD AS WELL. AGAIN, THE SURGEON WAS NOT ABLE TO SECURE THIS INTO PLACE USING THE STANDARD LOCKING MECHANISM. GIVEN THE INABILITY TO SECURE THE POLY, PLANS CHANGED TO A COMPLETE REVISION. THE SURGEON CAREFULLY REMOVED THE FEMORAL AND TIBIAL COMPONENTS. TIBIA AND FEMUR WERE REAMED. FULLY CEMENTED STEMS FOR TIBIA AND FEMUR WERE SELECTED. THERE WAS SIGNIFICANT BONE LOSS CENTRALLY AND A CONE WAS PREPPED FOR LATER PLACEMENT. 10 MM POSTERIOR AUGMENTS USED LATERALLY. CEMENT RESTRICTORS USED IN BOTH FEMUR AND TIBIA. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS AVAILABLE. THEY WERE SENT TO THE LAB AND LEGAL DEPARTMENT AT THE HOSPIT

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

  MAUDE report 21609460 ↗