Optetrak Logic 02-012-44-1009Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862173393), received between Aug 7, 2020 and Jun 6, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 reports).

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

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 93 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SWELLING, PAIN, DISCOMFORT, OSTEOLYSIS. 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: Discomfort; Failure of Implant; Implant Pain; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19475566 ↗
• InjuryDec 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REVISION SURGERY ON (B)(6) 2018. THEY UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 4 YEARS 2 MONTHS AFTER THEIR FIRST REVISION. "THE POLYETHYLENE WAS EXAMINED AND NOTED TO HAVE SEVERE WEAR RESEMBLING THE POLYETHYLENE AND ALMOST COMPLETELY WORN THROUGH. THE INTERFACE OF THE CEMENT AND BONE ON THE FEMUR WAS APPROACHED WITH CEMENT OSTEOTOMES AND THE FEMUR WAS NOTED TO BE EXTREMELY UNSTABLE. IT WAS VERY EASILY LOOSENED AND DEBONDED FROM THE UNDERLYING CEMENT. UPON REMOVING THE CEMENT FROM THE DISTAL FEMUR, SEVERE OSTEOLYSIS, PARTICULARLY OF THE MEDIAL FEMORAL CONDYLE WAS OBSERVED.¿ THE PATIENT WAS TAKEN TO THE PACU IN GOOD CONDITION, HAVING TOLERATED THE PROCEDURE WELL. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 18276510 ↗
• InjurySep 7, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 2 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND LEFT KNEE REVISION ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: OSTEOLYSIS AND LOOSENING OF LEFT KNEE. MEDIAL PARAPATELLAR ARTHROTOMY WAS PERFORMED AND SEROUS FLUID WAS EVACUATED FROM THE KNEE. THE PATIENT WAS NOTED TO HAVE HYPERTROPHIC SYNOVIUM BUT NO EVIDENCE OF PURULENCE OR INFECTION. SOFT TISSUES WERE ELEVATED FROM THE MEDIAL AND LATERAL TIBIA FOR EXPOSURE AND A FULL SYNOVECTOMY OF THE MEDIAL AND LATERAL GUTTERS AS WELL AS THE SUPRAPATELLAR POUCH WAS PERFORMED TO ALLOW FOR EXPOSURE. THE POLYETHYLENE WAS EXAMINED AND NOTED TO HAVE SEVERE WEAR RESEMBLING THE POLYETHYLENE AND ALMOST COMPLETELY WORN THROUGH. THE INTERFACE OF THE CEMENT AND BONE ON THE FEMUR WAS APPROACHED WITH CEMENT OSTEOTOMES AND THE FEMUR WAS NOTED TO BE EXTREMELY UNSTABLE. IT WAS VERY EASILY LOOSENED AND DEBONDED FROM THE UNDERLYING

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Inadequate Osseointegration; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 17697257 ↗
• InjuryJul 18, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL THE 76 Y/O FEMALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 10 YEARS AND 1 MONTH AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2023. DIAGNOSIS: BILATERAL FAILED TOTAL KNEE ARTHROPLASTY. THE PATELLAR COMPONENT WAS INSPECTED AND FOUND TO BE CATASTROPHICALLY DAMAGED WITH A FRACTURED PIECE LOOSE IN THE JOINT. DRESSINGS WERE APPLIED. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 17340890 ↗
• InjuryMay 23, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION A FEMALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 5 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023 DUE TO LEFT KNEE ASEPTIC LOOSENING FEMORAL COMPONENT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT REC'D ON 24 APR 2023. REVISED DUE TO ASEPTIC LOOSENING OF FEMORAL COMPONENT. PATIENT REVISED TO COMPETITOR'S DEVICES. DRESSINGS WERE APPLIED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 16987196 ↗
• InjuryApr 3, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED BY THE LEGAL BRIEF, ON (B)(6) 2013, PATIENT UNDERWENT TOTAL LEFT KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN OPTETRAK DEVICE, INCLUDING A SIZE 3, 9MM OPTETRAK LOGIC TIBIAL INSERTS MADE OF POLYETHYLENE. PATIENT WAS DIAGNOSED WITH ASEPTIC LOOSENING OF HER LEFT KNEE REPLACEMENT AND OSTEOLYSIS AND SHE UNDERWENT REVISION SURGERY OF HER LEFT KNEE ON (B)(6) 2021. DURING THE REVISION, PATIENT'S SURGEON STATED, "THERE WAS VERY EXTENSIVE SYNOVITIS AND A VERY THOROUGH SYNOVECTOMY OF THE JOINT WAS PERFORMED. THE POLYETHYLENE LINER WAS REMOVED. THERE WAS NOTED TO BE SEVERE WEAR OF THE LINER. NEXT THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND IT WAS REMOVED. THERE WAS SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH MARKED OSTEOLYSIS." UPON INFORMATION AND BELIEF, THE LOOSE COMPONENTS AND OSTEOLYSIS IN PATIENT'S LEFT KNEE WAS DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT.

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

  MAUDE report 16665218 ↗
• InjuryOct 12, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2016. BEGINNING ABOUT ONE YEAR POST-OP THE PATIENT BEGAN TO EXPERIENCE NUMBNESS IN HER RIGHT KNEE. IN (B)(6) OF 2018 SHE BEGAN EXPERIENCING DULL PAIN, SWELLING, LOCKING/CATCHING, AND STIFFNESS. ATTEMPTS TO TREAT HER SYMPTOMS WITH HEAT/ICE, ELEVATION, AND NSAIDS WERE INEFFECTIVE. THE IMPLANTING SURGEON SUSPECTED FEMORAL LOOSENING DUE TO EARLY POLYTHYLENE WEAR. THE PATIENT WAS REVISED ON (B)(6) 2019. UPON EXPLANTATION OF THE DEVICES, THE SURGEON OBSERVED SIGNIFICANT GRANULATION TISSUE DUE TO POLYETHYLENE WEAR, AND NOTED "EXCESSIVE WEAR IN THE MEDIAL AND LATERAL COMPONENTS WHEN COMPARED TO NORMAL WEAR." THE FEMORAL COMPONENT WAS "COMPLETELY LOOSE" AND WAS REMOVED WITHOUT EFFORT. UPON INFORMATION AND BELIEF, THE POLYETHYLENE INSERT WAS DEFECTIVE, LEADING TO EARLY ASEPTIC LOOSENING.

  Patient problems: Failure of Implant

  MAUDE report 15590330 ↗
• InjuryFeb 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 8.05 YEARS SINCE INITIAL IMPLANT, THIS FEMALE PATIENT WITH BMI 24.9 UNDERWENT A LEFT SIDE TKA AND WAS IMPLANTED WITH AN EXACTECH UHMWPE INSERT, SERIAL # (B)(4). ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.

  Patient problems: Failure of Implant

  MAUDE report 13451482 ↗
• InjuryAug 7, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2015, A (B)(6) Y/O, FEMALE PATIENT WITH A BMI OF 34.2, UNDERWENT IMPLANTATION OF A INSERT TIB 1 11MM KNEE POST STAB CNSTRN AND INSERT TIB 1 9MM KNEE POST STAB CNSTRN. ON (B)(6) 2019, APPROXIMATELY 47 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING.

  Patient problems: Failure of Implant

  MAUDE report 10382237 ↗