Optetrak Logic 02-010-06-0350Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862265739), received between Oct 14, 2021 and Sep 7, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjurySep 7, 2022Unstable; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect; Unstable; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect

  IT WAS REPORTED THAT THIS MALE PATIENT WAS FORCED TO UNDERGO A PAINFUL REVISION SURGERY ON HIS RIGHT KNEE BECAUSE THE OPTETRAK KNEE REPLACEMENT DEVICE THAT WAS USED IN HIS TOTAL KNEE REPLACEMENT FAILED PREMATURELY.

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

  MAUDE report 15372879 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY FOUR YEARS POST RTKA, THE APPROXIMATELY (B)(6) YEAR OLD MALE PATIENT COMPLAINTS OF MICROMOVEMENTS UPON WALKING AND SEVERE PAIN WITHIN SIX MONTHS AFTER HIS REVISION IN (B)(6) 2016. THE EVENT IS POSSIBLY RELATED TO THE DEVICE BUT UNLIKELY RELATED TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 12636795 ↗

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