Optetrak Logic 02-010-06-0230Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862265661), received between Mar 2, 2020 and Jun 18, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 52 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, STIFFNESS, PAIN, ARTHRITIS, AND SCARRING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19558270 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY THIRTEEN MONTHS POST TKA, THE (B)(6) Y/O MALE PATIENT COMPLAINT OF STIFFNESS AND PAIN TO LEFT KNEE WITH DIFFICULTY WALKING, ASCENDING AND DESCENDING STAIRS. THE EVENT IS POSSIBLY RELATED TO THE DEVICE BUT UNLIKELY RELATED TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 13057242 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 10 MONTHS POSTOP THE INITIAL IMPLANT, THIS (B)(6) Y/O FEMALE PATIENT HAD A LTKA REVISION DUE TO INFECTION. ALL IMPLANTS WERE REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISPOSED BY HOSPITAL.

  Patient problems: Bacterial Infection

  MAUDE report 12089005 ↗
• InjuryMar 2, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY 2 YRS. AND 8 MONTHS, THE (B)(6) Y/O FEMALE PATIENT, WEIGHT (B)(6) LBS, EXPERIENCED CHRONIC ASEPTIC LOOSENING OF LEFT TKA AND ALL COMPONENTS WERE REVISED. PATIENT COMPLAINED OF PAIN AND INSTABILITY OF LEFT KNEE. THE EVENT IS POSSIBLY RELATED TO THE DEVICE BUT UNLIKELY RELATED TO THE PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 9775103 ↗
• InjuryMar 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE (B)(6) Y/O FEMALE PATIENT INITIALLY COMPLAINED OF SEVERE PAIN AND PRESSURE TO THE LEFT KNEE FOR THREE MONTHS. PATIENT WEIGHT IS (B)(6) LBS. THE PATIENT WAS REVISED. THE EVENT IS POSSIBLY RELATED TO THE DEVICE BUT UNLIKELY RELATED TO THE PROCEDURE. INITIAL IMP. DATE IS UNKNOWN, IT IS KNOWN IT WAS IN 2019.

  Patient problems: Pain

  MAUDE report 9775033 ↗

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