Optetrak Logic 02-010-03-0325Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862158109), received between Mar 14, 2024 and Jun 3, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

1 other recall cover devices cleared under the same FDA submission (K111400); 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.

• InjuryJun 3, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 54 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSE FEMUR, CRUSHED MEDIAL FEMORAL CONDYLE AND CAVITARY DEFECT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19455090 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION FROM AUSTRALIA THAT A PATIENT EXPERIENCED A RIGHT KNEE SURGICAL REVISION ON (B)(6) 2023 [REPORTED IN MFR#1038671-2023-00784], EXPERIENCED AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2023 FOR A POSSIBLE INFECTION AND THEN WAS SURGICALLY REVISED ON (B)(6) 2023, TO COMPETITOR'S DEVICES. REVISION OF (B)(6) 2023-THE ORIGINAL MIDLINE INCISION WAS UTILIZED AND A MEDIAL ARTHROTOMY PERFORMED. THE KNEE COMPONENTS WERE NOT OBVIOUSLY LOOSE. ALL COMPONENTS (AS WELL AS CEMENT), INCLUDING THE PATELLA BUTTON, WERE REMOVED WITH OSTEOTOMES, OSCILLATING SAW AND PUNCHES. MULTIPLE SYNOVIAL TISSUE SPECIMENS WERE TAKEN FOR MICROBIOLOGY. AFTER REMOVAL OF COMPONENTS, THERE WAS ONLY MINOR UNCONTAINED DEFECTS IN THE CENTRAL TIBIA. USING INTRAMEDULLARY FEMORAL AND TIBIAL RODS FOR REFERENCING, THE ENDS OF THE TIBIA FOLLOWED BY THE FEMUR, WERE FASHIONED USING GUIDES. THE KNEE WAS THEN BROUGHT THROUGH A RANGE OF MOTION WITH TRIAL COMPONENTS IN SITU. DEFINITIVE COMPONENTS USED WERE ALL CEMENTED CONSISTING OF: FEMORAL COMPONENT (# 4 WITH 8MM DISTAL LATERAL AND 4MM DISTAL MEDIAL AUGMENTS, PRESS FIT STEM 16MM X 60MM), POLYETHYLENE INSERT (ROTATING VVS/ SPINE, 8MM), TIBIAL TRAY (# 4, W

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 18902528 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. 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