Optetrak Logic 02-012-35-1009Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10885862001689), received between Oct 30, 2020 and Oct 17, 2024 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 92 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, MECHANICAL FAILURE OF LEFT TOTAL KNEE REPLACEMENT REQUIRING REVISION SURGERY; INJURIES TO BONE AND TISSUE; BILATERAL LEFT KNEE PAIN; SWELLING, REDUCED FUNCTIONING; LOSS OF RANGE OF MOTION; GREAT PAIN AND ANGUISH. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 20473707 ↗
• InjuryJun 5, 2024Peeled/Delaminated; Unstable; Naturally Worn; Peeled/Delaminated; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 96 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR PAIN, STIFFNESS, SWELLING AND LOSS OF MOBILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ankylosis; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 19473337 ↗
• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 115 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, SEVERE PAIN, SWELLING, AND INSTABILITY. 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; Implant Pain; Insufficient Information; Swelling/ Edema

  MAUDE report 19280155 ↗
• InjuryApr 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, WITH NO REPORTED REVISION. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 19103672 ↗
• InjuryFeb 13, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2023, APPROXIMATELY 7 YEARS AFTER INITIAL IMPLANT. THE PATIENT EXPERIENCED LOOSENING OF THE OPTETRAK POLYEHTYLENE TIBIAL INSERT. THERE IS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. THERE ARE NO X-RAYS OR IMAGES PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Pain

  MAUDE report 18697817 ↗
• InjuryDec 18, 2023Naturally Worn; Naturally Worn

  UBARMIN #31 DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. ON 28-NOV-2023 UPDATES TO THE EXCEL LISTING WERE PROVIDED. THIS PATIENT (B)(6) WAS IMPLANTED WITH A 02-012-35-1009 LOGIC TIBIA PS MOD INSRT SZ 1 9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2016. THE INSERT WAS MANUFACTURED ON 3/24/2015 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 3/24/2015 AND WAS 1.02 YEARS SHELF AGE AT THE TIME OF IMPLANT. PENDING REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18352559 ↗
• MalfunctionDec 14, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON SITE VISIT WITH UBARMIN HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. ON 28-NOV-2023 UPDATES TO THE EXCEL LISTING WERE PROVIDED. THIS PATIENT WAS IMPLANTED WITH A LOGIC TIBIA PS MOD INSRT SZ 1 9MM (CAT# 02-012-35-1009 / SERIAL# (B)(6)) ON (B)(6) 2016. THE INSERT WAS MANUFACTURED ON 7-JAN-2015 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS 1.10 YEARS SHELF AGE AT THE TIME OF IMPLANT. PATIENT IS PENDING REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18331543 ↗
• InjuryMay 21, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT (B)(6), WAS IMPLANTED WITH A 02-012-35-1009-INSERTO TIBIAL LOGIC PS 1, 9 MM, SERIAL NUMBER (B)(6), ON (B)(6) 2014. THE INSERT WAS MANUFACTURED ON (B)(6) 2012, AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON (B)(6) 2012, AND WAS 1.2 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON 2017, APPROXIMATELY THREE YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16971056 ↗
• InjuryMar 1, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL LEFT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2018 AND WAS IMPLANTED WITH AN OPTETRAK DEVICE. IN 2019 AND 2020, PLAINTIFF EXPERIENCED EXTREME PAIN AND DISCOMFORT IN HER LEFT KNEE WHICH LIMITED HER ACTIVITIES OF DAILY LIVING AND HER QUALITY OF LIFE. PLAINTIFF UNDERWENT REVISION SURGERY ON HER LEFT KNEE ON (B)(6) 2021, APPROXIMATELY 2 YEARS 11 MONTHS POST INITIAL PROCEDURE, AND THE POLYETHYLENE LINER AND THE ENTIRE FEMUR AND TIBIAL COMPONENTS WERE REVISED. PATHOLOGY INDICATED, IN PART, ¿FIBROUS TISSUE WITH MARKED FOREIGN-BODY GIANT CELL REACTION". NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Implant Pain; Pain

  MAUDE report 16461681 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT, INITIAL KNEE IMPLANT DATE, (B)(6) 2019 , HAD DEVICES REMOVED ON (B)(6) 2022. APPROXIMATELY 4 YEARS POST THE INITIAL PROCEDURE. REASON FOR THE REVISION UNKNOWN. NO PRODUCT RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16368733 ↗
• InjuryFeb 13, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED VIA LEGAL DEPARTMENT -REVISION SURGERY OPERATIVE REPORT ON (B)(6) 2021. THERE WAS A VERY LARGE EFFUSION OF THE KNEE WITH CLOUDY YELLOW FLUID, THIS WAS COLLECTED AND SENT FOR FLUID CULTURE. THE KNEE WAS INSPECTED. THERE WAS NEAR TOTAL CATASTROPHIC FAILURE OF THE POLYETHYLENE INVOLVING THE POST AND MEDIAL COMPARTMENT WITH MODERATE POLYETHYLENE LOSS IN THE LATERAL COMPARTMENT. THERE WAS EXTENSIVE SYNOVITIS. THERE WAS OSTEOLYSIS INVOLVING THE PROXIMAL TIBIA AND DISTAL FEMUR. A COMPLETE SYNOVECTOMY WAS PERFORMED FOR PURPOSE OF REMOVAL OF ALL POLYETHYLENE DEBRIS AS WELL AS EXPOSURE. THE FEMORAL COMPONENT WAS ABLE TO BE REMOVED AS IT WAS DEBONDED FROM THE CEMENT MANTLE. THE CEMENT WAS REMOVED AND REVEALED EXTENSIVE OSTEOLYSIS INVOLVING THE MEDICAL AND LATERAL FEMORAL CONDYLES AND INTO THE DISTAL FEMORAL METAPHYSIS. THE TIBIAL COMPONENT WAS REMOVED IN A SIMILAR FASHION, AND THIS ALSO HAD LARGE OSTEOLYTIC LESION INVOLVING THE METAPHYSIS. THE PATELLA COMPONENT WAS INSPECTED AND FOUND TO BE FIXED TO THE PATELLA. A STERILE BANDAGE WAS APPLIED, AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM HAVING TOLERATED THE PROCEDURE WELL. THERE IS NO OTHER PATIENT DEMO

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 16363396 ↗
• InjuryDec 2, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL BRIEF, ON OR ABOUT (B)(6) 2017, THE SURGEON IMPLANTED THE EXACTECH OPTETRAK INTO THE RIGHT KNEE OF PATIENT. ON OR ABOUT (B)(6) 2022, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE OPTETRAK AND REPLACED IT WITH ANOTHER IMPLANT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15905067 ↗
• InjuryNov 4, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A FEMALE PATIENT, RIGHT KNEE IMPLANTED ON (B)(6) 2010, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 12 YEARS 4 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR REASONS UNKNOWN.

  Patient problems: Aseptic loosening; No Clinical Signs, Symptoms or Conditions; Osteolysis; Pain

  MAUDE report 15723970 ↗
• InjuryFeb 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7.59 YEARS SINCE INITIAL IMPLANT, THIS FEMALE PATIENT WITH BMI 20.7 UNDERWENT A RIGHT SIDE TKA AND WAS IMPLANTED WITH AN EXACTECH UHMWPE INSERT, SERIAL #:(B)(4). ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.

  Patient problems: Failure of Implant

  MAUDE report 13413654 ↗
• MalfunctionApr 27, 2021Crack; Crack

  AS REPORTED, DURING THE INITIAL IMPLANT FOR THIS (B)(6) FEMALE PATIENT, THE POLYETHYLENE TIBIAL INSERT SIZE1, 9MM TWO (2) PIECES WERE CRACKED WHEN THE SURGEON WAS INSERTING THE TIBIAL INSERT DRIVER (BEFORE IMPACTION). THE CRACK WAS FOUND DAMAGED IN THE AREA IN CENTRAL MUSHROOM HOLE, PERIPHERAL RIM AND BACKSIDE OF ARTICULAR SURFACE. THE OPERATION TIME DELAYED ABOUT ONE HOUR. THE DEVICES WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11733746 ↗
• InjuryOct 30, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2012, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2010. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10760087 ↗

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-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