Truliant CC 02-012-65-4013Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862613493), received between Apr 9, 2024 and May 28, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 4 YEARS POST INITIAL OPERATION. SUBSEQUENTLY, THE PATIENT PRESENTED TO SURGEON WITH A LOOSE TIBIA AND PATELLA. SURGEON REMOVED A 38 PATELLA, A SIZE 4F/3T TIBIAL TRAY AND A 14 X 25 TIBIAL STEM. ALSO THE LINER WAS A SIZE 4/13MM CONSTRAINED PS INSERT. THE SURGEON REVISED TO A THE TIBIA TO A 4F/3T WITH A 16 X 80 STEM. THE PATELLA WAS REVISED TO A 41MM THREE PEG PATELLA. A 32 TIBIAL METAPHYSEAL CONE AND A. 4/19MM CONSTRAINED INSERT. THE PATIENT IS EXTREMELY ACTIVE AND DOES MANUAL LABOR FOR WORK. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22097564 ↗
• InjuryDec 26, 2024Naturally Worn; Naturally Worn

  PER A REPORT FROM THE LEGAL DEPARTMENT, THE PATIENT HAD AN INITIAL RIGHT KNEE IMPLANTED. THE PATIENT HAD TWO REVISIONS OF THE RIGHT KNEE. OP REPORT PRE & POST OP DIAGNOSIS: FAILED TOTAL RIGHT KNEE REPLACEMENT. INDICATIONS: PATIENT HAD SEVERE PAIN DUE TO FAILED ASEPTIC LOOSENING OF TOTAL RIGHT KNEE REPLACEMENT. PT HAS FAILED CONSERVATIVE TREATMENT AND WISHED TO UNDERGO OPERATIVE INTERVENTION. RISKS, BENEFITS, AND ALTERNATIVES DISCUSSED WITH PATIENT. DESPITE POTENTIAL RISKS, THEY WISHED TO PROCEED WITH THE OPERATIVE INTERVENTION. INTRAOPERATIVE FINDINGS: LOOSE FEMORAL IMPLANT - REMOVED EASILY WITH MINIMAL BONE LOSS BUT CONCERNED FOR BONE QUALITY DISTAL FEMUR. I ELECTED TO SUE FEMORAL CONE. TIBIAL IMPLANT WAS VERY SOLID AND WELL FIXED - BACKSLAP DEVICE AND OSTEOTOMES WERE USED BUT STEM WOULD NOT BUDGE - CORTICAL WINDOW DISTAL TO THE STEM ALLOWED ME TO HIT THE STEM TIP AND KNOCK IT OUT RETROGRADE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Pain

  MAUDE report 21021297 ↗
• InjuryApr 9, 2024Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, WITH NO REVISION SURGERY REPORTED. THERE IS NO DEVICE INFORMATION PROVIDED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19068871 ↗

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