Truliant CC 02-012-65-2015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862613325), received between Jun 18, 2024 and Mar 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2025Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 97 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, FEMORAL COMPONENT LOOSENING, INCREASING PAIN, MARKED STIFFNESS AND DECREASED RANGE OF MOTION. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. FINDINGS INDICATED GROSS LOOSENING FEMORAL COMPONENT; MARKED ARTHROFIBROSIS WITHOUT EVIDENCE OF INFECTION; OSTEOPENIA WITH SIGNIFICANT PROXIMAL FEMORAL BONE THINNING; SUBSIDENCE OF THE PATELLAR COMPONENT WITH AGGRESSIVE BONE OVERGROWTH AND PATELLA BAJA. THE SURGEON PERFORMED A REVISION OF THE FEMORAL COMPONENT AND TIBIAL POLYETHYLENE. THE SURGEON NOTED THAT THE FEMORAL CONDYLE MEDIALLY CRACKED DURING IMPACTION OF THE REVISION FEMORAL COMPONENTS, WHICH WAS THEN STABILIZED WITH A PIN. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM WITHOUT DIFFICULTY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification; Fibrosis; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Scar Tissue

  MAUDE report 21679761 ↗
• InjuryJun 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE LEFT KNEE, WITH NO REVISION SURGERY REPORTED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF'S MOBILITY AND QUALITY OF LIFE. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19559883 ↗

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