Truliant CC 02-012-65-2013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862613318), received between Dec 26, 2024 and Dec 26, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  APPROXIMATELY TWO-YEAR POST INITIAL LEFT SIDE TKA, THE 86 Y/O FEMALE PATIENT HAD A REVISION. PREOPERATIVE DIAGNOSIS-FAILED LEFT KNEE ARTHROPLASTY DUE TO INSTABILITY, POOR MOTION, PAIN AND PATELLAR COMPONENT LOOSENING. PATIENT WAS REVISED TO SAME COMPANY DEVICES. THE FEMORAL COMPONENT ROTATION WAS OKAY, MATCHING THE EPICONDYLAR AXIS. THERE WAS DENSE SCAR THROUGHOUT THE KNEE IN EXTENSION WITH MEDIAL LIFTOFF OF 5MM WITH VALGUS STRESS. BOTH THE FEMORAL AND TIBIAL COMPONENTS APPEARED TO BE APPROPRIATELY SIZED AND IN APPROPRIATE ROTATION. THERE WAS NO EVIDENCE OF LOOSENING OF EITHER THE FEMORAL OR TIBIAL COMPONENTS. THE JOINT FLUID WAS CLEAR AND YELLOW. THERE WAS NO EVIDENCE OF DEEP INFECTION. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. THERE IS NO OTHER INFORMATION AVAILABLE. RIGHT KNEE REVISION REPORTED UNDER MDR # 1038671-2023-00338.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 21019644 ↗

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