Optetrak 244-02-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862063793), received between Feb 12, 2020 and Dec 15, 2020 — classified as 4 injuries.

3 other recalls cover devices cleared under the same FDA submission (K033883); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) PATIENT AT (B)(6) EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2017, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2008. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11009324 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6), THIS (B)(6), MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2009. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2010, APPROXIMATELY 18 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO OTHER INDICATION FOR REVISION. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY (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: No Information

  MAUDE report 9712237 ↗
• 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, MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT OF THE LEFT KNEE ON (B)(6) 2010. THE INDICATION FOR THE INDEX PROCEDURE WAS PREVIOUS INFECTION. ON (B)(6) 2011, APPROXIMATELY 12 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY AND PAIN. 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: Failure of Implant

  MAUDE report 9703575 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, (BMI=(B)(6)) MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE L KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2009. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A OPTETRAK HI-FLEX CEMT FEM COMP ASYMMETRIC SIZE 4 LEFT (CATALOG 244-02-04, SERIAL (B)(4)), OPTETRAK RBK CEMT FINNED TIBIAL TRAY 4F/5T (CATALOG 260-04-45, SERIAL (B)(4)), OPTETRAK POSTERIOR STABILISED RBK TIB INSERT SIZE 4 9MM (CATALOG 264=24-09, SERIAL (B)(4)), AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2015, APPROXIMATELY 73 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. THE EXACTECH WERE REMOVED AND REPLACED.

  Patient problems: Bacterial Infection

  MAUDE report 9699470 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts,
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants