Optetrak 244-02-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862063786), received between Feb 12, 2020 and Dec 31, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 146 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, INSTABILITY, JOINT LAXITY, PAIN, SCAR TISSUE, SYNOVITIS, AND FAILURE OF IMPLANT. 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: Failure of Implant; Joint Laxity; Pain; Scar Tissue; Synovitis

  MAUDE report 21048300 ↗
• InjurySep 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 173 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN; EFFUSION, SEVERE SYNOVITIS AND OSTEOLYSIS; FEMORAL AND TIBIAL LOOSENING; DISCOLORATION AND DELAMINATION OR BREAKAGE ON THE TIBIAL INSERT, POSSIBLE DEFECT OF THE PATELLA POLYETHYLENE. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20212774 ↗
• InjuryAug 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 181 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND SEVERE PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Failure of Implant; Implant Pain; Pain; Scar Tissue

  MAUDE report 20049072 ↗
• 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), FEMALE 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) 2018, APPROXIMATELY 109 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 9712903 ↗
• 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), A (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT OF THE LEFT KNEE ON (B)(6) 2010. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2010, APPROXIMATELY 7 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 UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); 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 9703531 ↗

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