Optetrak 244-02-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862063779), received between Feb 13, 2020 and Jan 28, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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.

• InjuryJan 28, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. AFTER THE LEFT TOTAL KNEE REPLACEMENT SURGERY, THE PATIENT BEGAN TO SUFFER FROM SYMPTOMS INCLUDING BUT NOT LIMITED TO PROSTHETIC WEAR, INSTABILITY AND LOOSENING, PAIN AND LACK OF MOBILITY. AS A RESULT OF THESE SYMPTOMS, PATIENT UNDERWENT LEFT KNEE REVISION SURGERY APPROXIMATELY 2 YEARS 4 MONTHS AFTER THEIR INITIAL REPLACEMENT. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONES, WHICH LEFT TO ASEPTIC (NON-INFECTED) LOOSENING AND INSTABILITY. HOWEVER, THIS CANNOT BE CONFIRMED AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS/PHOTOGRAPHS WERE NOT PROVIDED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Failure of Implant; Joint Laxity; Pain; Synovitis

  MAUDE report 21255221 ↗
• InjuryJan 16, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 105 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT THE PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT EXPERIENCED PAIN AND NOISES. A POST OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS NOTED POLYETHYLENE FAILURE, METALLOSIS AND ASEPTIC LOOSENING. INTRAOPERATIVELY THE SURGEON OBSERVED SIGNIFICANT METALLOSIS AND NECROTIC TISSUE AND SYNOVITIS. ALTHOUGH NO SIGNS OF INFECTION. THE PATELLAR COMPONENT WAS NOTED TO BE SIGNIFICANTLY LOOSE WITH METALLOSIS AND POCKETS OF DEFECT IN THE PATELLA. THE TIBIAL TRAY COMPONENT WAS REMOVED, AND THE SURGEON OBSERVED SIGNIFICANT METALLOSIS WITH NECROTIC TISSUE POSTERIORLY, POSTERIOR MEDIAL AND LATERALLY AS WELL AS A LARGE BONY DEFECT ENCOMPASSING ALMOST THE WHOLE LATERAL FEMORAL CONDYLE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Metal Related Pathology; Pain; Synovitis; Tissue Breakdown

  MAUDE report 21171883 ↗
• InjuryFeb 13, 2020Naturally Worn; Naturally Worn

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2011. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2018, APPROXIMATELY 89 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY, PATIENT CONDITION (MALALIGNMENT) AND WEAR OF POLYETHYLENE COMPONENT. MALALIGNMENT WAS NOT DEFINED IN THE REPORTED COMPLAINT INFORMATION,[THIS COULD MEAN THAT THE PATIENT CAUSED IMPLANTS TO BE OUT OF ALIGNMENT OR THAT THE SURGICAL PROCEDURE DID; THIS IS WILL BE INVESTIGATED AS ¿PATIENT CONDITION¿]. THE 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. TOTAL KNEE REPLACEMENT INSTABILITY IS NOTED TO OCCUR DUE TO SURGICAL TECHNIQUES OF CREATING EXCESSIVE FLEXION GAPS, INADEQUATE FILLING OF THE EXTENSION SPAC

  Patient problems: Failure of Implant

  MAUDE report 9709920 ↗
• InjuryFeb 13, 2020Naturally Worn; Naturally Worn

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6)2008. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2017, APPROXIMATELY 118 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY, OSTEOLYSIS OF THE FEMUR (LYSISFEMUR), AND WEAR OF POLYETHYLENE COMPONENT. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (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. TOTAL KNEE REPLACEMENT INSTABILITY IS NOTED TO OCCUR DUE TO SURGICAL TECHNIQUES OF CREATING EXCESSIVE FLEXION GAPS, INADEQUATE FILLING OF THE EXTENSION SPACE DUE TO THE COMPONENTS NOT BEING THICK ENOUGH, SOFT TISSUE/LIGAMENT DAMAGE, AND/OR INJURY INCURRED DURING POST-OP REHABILITATION THERAPY. MUSCULOSKELETAL KEY, (B)(6) 2018). TREATMENT OF INSTABILITY AFTER TOTAL KNEE REPLACEMENT; ELECTRONIC SOURCE. IT IS KNOWN THAT BONE MINERAL DENSITY AT A TOTAL KNEE ARTHROP

  Patient problems: Failure of Implant

  MAUDE report 9709900 ↗
• InjuryFeb 13, 2020Naturally Worn; Naturally Worn

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, 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) 2019, APPROXIMATELY 123 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY, PATIENT CONDITION (MALALIGNMENT) AND WEAR OF POLYETHYLENE COMPONENT. MALALIGNMENT WAS NOT DEFINED IN THE REPORTED COMPLAINT INFORMATION,[THIS COULD MEAN THAT THE PATIENT CAUSED IMPLANTS TO BE OUT OF ALIGNMENT OR THAT THE SURGICAL PROCEDURE DID; THIS IS WILL BE INVESTIGATED AS ¿PATIENT CONDITION¿]. THE FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (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. TOTAL KNEE REPLACEMENT INSTABILITY IS NOTED TO OCCUR DUE TO SURGICAL TECHNIQUES OF CREATING EXCESSIVE FLEXION GAPS, INADEQUATE FILLING OF THE EXTENSION SPACE DUE TO THE COMPONENTS NOT BEING THICK ENOUGH, SOFT TISSUE/LIGAMENT DAMAGE,

  Patient problems: Failure of Implant

  MAUDE report 9709768 ↗

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