Optetrak Logic 02-010-03-0320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862158093), received between Dec 4, 2019 and Mar 6, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL DETAILS FROM A LEGAL SHORT FORM AND OPERATIVE REPORT. THE SHORT FORM INDICATED THE PATIENT SUFFERED IMMENSE PAIN, LOSS OF CONSORTIUM, AND LOSS OF MOBILITY. PRE-OPERATIVE DIAGNOSIS-FAILED RIGHT TOTAL KNEE ARTHROPLASTY DUE TO INSTABILITY. POST-OPERATIVE DIAGNOSIS-FAILED RIGHT TOTAL KNEE ARTHROPLASTY DUE TO INSTABILITY, PROBABLY RIGHT DISEASE, AND FEMORAL COMPONENT DEBONDING. ONCE THE SURGEON ENTERED THE JOINT, THERE WERE A SIGNIFICANT AMOUNT OF SYNOVIAL TISSUE CONSISTENT WITH POLY WEAR DISEASE. SIGNIFICANT POLY WEAR OBSERVED ON THE WEIGHT BEARING PORTION OF THE LATERAL CONDYLE. THE FEMORAL COMPONENT WAS DEBONDED FROM THE UNDERLYING BONE, AND THE TIBIAL COMPONENT WAS IN SIGNIFICANT VARUS MALALIGNMENT.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 18852269 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6) NATIONAL JOINT REGISTRY ((B)(6)), A (B)(6) Y/O, 161 CM, (B)(6) KG (BMI=31), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2014. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2015, APPROXIMATELY 8 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (B)(6) NATIONAL JOINT REGISTRY ((B)(6)); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: Bacterial Infection

  MAUDE report 9700356 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A (B)(6) FEMALE WAS INITIALLY IMPLANTED ON (B)(6) 2016. ON (B)(6) 2019 THE PATIENT WAS REVISED DUE TO INSTABILITY. THE DEVICES WERE DISPOSED OF BY THE HOSPITAL. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 9413286 ↗

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