Truliant CC 02-010-06-0240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862612410), received between Oct 21, 2024 and Aug 11, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. DURING THE PROCEDURE, IT WAS NOTED THAT AN INTRA-OPERATIVE DISTAL FEMUR FRACTURE OCCURRED WHILE CEMENTING ON THE FINAL FEMORAL COMPONENT. IT WAS MENTIONED THAT THE ANTERIOR FLANGE OF THE IMPLANT WAS CAUGHT ON THE ANTERIOR CORTEX, RESULTING IN A FEMORAL SPLIT OF APPROXIMATELY TWO (2) CENTIMETERS. THE FRACTURE WAS FIXED USING TWO SUTURE CERCLAGE. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 22777284 ↗
• InjuryOct 21, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA (MDL NO. (B)(4)). PATIENT ID: (B)(6) + LEFT KNEE. (B)(6) 2024: ATTACHED LEGAL SHORT FORM. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4), AND PENDING IN THE (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE. AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY 4.1 YEARS POST INITIAL LEFT TKA, THE 59 YEAR OLD MALE PATIENT HAD A REVISION DUE TO PREMATURE POLY WEAR AND POLY RECALL WITH OSTEOLYSIS AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. DURING REVISION SURGERY, IT WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WERE FOUND TO BE GROSSLY LOOSE FEMORAL AND TIBIAL COMPONENTS THAT WERE EASI

  Patient problems: Failure of Implant; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20494596 ↗

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