Truliant CC 02-012-65-2021Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862613356), received between Feb 29, 2024 and Mar 31, 2026 — classified as 1 death, 1 injury.

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

4 other recalls cover devices cleared under the same FDA submission (K150890); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE ON A LEFT TKA, A POLY-TO-TIBIAL TRAY MISMATCH WAS LEFT UNCORRECTED: A SIZE 2 CC POLY WITH A 2.5F/3T TIBIAL TRAY. DURING THE REVISION, A 2.5F/3T TIBIAL TRAY WAS IMPLANTED WITH A 14MM O.D. X 25MM LENGTH STEM, WITH THE PLAN FOR A LEFT 2.5 PS FEMORAL COMPONENT. AFTER THE TIBIA WAS CEMENTED, THE FEMORAL COMPONENT WAS IMPLANTED WITH CEMENT. AFTER HOLDING THE FEMORAL COMPONENT TO THE FEMUR FOR ROUGHLY 10 MINUTES TO ENSURE THE CEMENT HAD SET, HE LET GO AND REALIZED THE FEMORAL COMPONENT WAS NOT STAYING. THE SURGEON DECIDED TO GO TO A CC FEMUR WITH A STEM. A SIZE 2 CC FEMUR WITH A 17MM CC TIBIAL INSERT. THEY CEMENTED A LEFT SIZE 2 CC FEMUR WITH A 14 MM O.D. X 120MM LENGTH STEM. THEY THEN INSERTED THE 17MM CC TIBIAL INSERT AND REALIZED A LARGER INSERT WAS NEEDED, THUS REMOVING AND INSERTING A 21MM CC TIBIAL INSERT WITH THE LOCKING SCREW GOING THROUGH THE TIBIAL INSERT, THE TIBIAL TRAY, AND THE STEM. THE FINAL CONSTRUCT IMPLANTED IN THE PATIENT WAS A LEFT SIZE 2 CC FEMORAL COMPONENT WITH A 14 MM O.D. X 120MM LENGTH STEM ON THE FEMORAL SIDE. ON THE TIBIAL SIZE, THERE IS SIZE 2 21MM CC TIBIAL INSERT WITH A SIZE 2.5F/3T TIBIAL TRAY, AND A 14MM O.D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24748518 ↗
• DeathFeb 29, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 4 YEARS AND 6 MONTHS AFTER INITIAL IMPLANT. THERE IS NO DEVICE INFORMATION PROVIDED. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18806969 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150890. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
• Z-1364-2020 · Jan 27, 2020 · Open, Classified
  Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, s
• Z-3209-2018 · May 8, 2018 · Open, Classified
  Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total k
• Z-2704-2017 · Apr 7, 2017 · Terminated
  Exactech Optetrak Logic CC 15mm Tibial Augment Screws