Optetrak Logic 02-012-35-2015Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862001757), received between Oct 8, 2019 and Sep 24, 2024 — classified as 12 injuries.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 86 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING AND STIFFNESS, LIMITED ROM, LOSS OF MOBILITY, REVISION SURGERY, POLYETHYLENE WEAR, CONSTRAINED LINER REVISION.. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20291311 ↗
• InjurySep 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 106 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Osteolysis; Synovitis

  MAUDE report 20148651 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC FEMORAL LOOSENING. INDICATIONS FOR PROCEDURE: THE PATIENT IS A 67-YEAR-OLD FEMALE, WHO IS APPROXIMATELY 10 YEARS STATUS POST A LEFT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. OVER THE PAST SEVERAL MONTHS, SHE HAS HAD INCREASING PAIN AND PERSISTENT EFFUSIONS. X-RAYS SHOW OSTEOLYSIS BEHIND THE FEMUR AND ECCENTRIC POLYETHYLENE WEAR. INFECTION WORKUP HAS BEEN NEGATIVE. DESCRIPTION OF PROCEDURE: UPON THE KNEE JOINT, THERE WAS NOTED TO BE A LARGE AMOUNT OF SYNOVIAL FLUID, WHICH WAS SENT FOR GRAM STAIN AND CULTURE. THE MEDIAL AND LATERAL GUTTERS WERE REESTABLISHED. A SYNOVECTOMY WAS PERFORMED. THE PATELLA WAS EVERTED AND FOUND TO BE WELL FIXED. THE KNEE WAS FLEXED. AFTER THE PATELLA WAS SUBLUXED, THE PREVIOUS POLYETHYLENE WAS REMOVED. THERE WAS SIGNIFICANT WEAR MEDIALLY. FEMORAL COMPONENT WAS DISIMPACTED THAT WAS LOOSE, TIBIAL COMPONENT WAS INTACT. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint effusion; Osteolysis; Pain

  MAUDE report 20072431 ↗
• InjuryJun 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 95 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, POPPING, AND LOOSENING OF KNEE JOINT PROSTHESIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Pain

  MAUDE report 19477006 ↗
• InjuryMay 3, 2024Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 168 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN AND DISCOMFORT, SWELLING, GAIT IMPAIRMENT, POOR BALANCE, AND COMPONENT PART LOOSENING. 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; Discomfort; Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19237430 ↗
• InjuryMay 3, 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 APPROXIMATELY 168 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN AND DISCOMFORT, SWELLING, GAIT IMPAIRMENT, POOR BALANCE, AND COMPONENT PART LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19237120 ↗
• InjuryFeb 15, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  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) 2022, APPROXIMATELY 6 YEARS, 2 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18716638 ↗
• InjuryJul 3, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD A PREVIOUS POLY SWAP ON (B)(6) 2021. THE PATIENT WAS REVISED AGAIN ON (B)(6) 2023 DUE TO SEVERE POLY WEAR. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17253181 ↗
• InjuryMay 23, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO EVOLVING CHRONIC LAXITY, FUNCTIONAL IMPAIRMENT INSTABILITY, FEMORAL METAPHYSEAL PAIN, CHRONIC HYDRARTROSIS , AND WEAR OF PE INSERT WITH FEMORAL GEODE CAVITY FEMORAL LOOSENING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL INFORMATION PROVIDED. UNABLE TO OBTAIN PHOTOS/X-RAYS. DEVICES ARE RETURNING.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Failure of Implant; Implant Pain; Joint Laxity; Joint effusion

  MAUDE report 16988216 ↗
• InjuryApr 10, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT ON (B)(6) 2013, THIS PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT AND WAS IMPLANTED WITH AN OPTETRAK POLYETHYLENE TIBIAL INSERT (SERIAL #: (B)(4)) AND THEN ON (B)(6) 2022, APPROXIMATELY 9 YEARS 2 MONTHS AFTER IMPLANT, THEY UNDERWENT A RIGHT KNEE REVISION SURGERY DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK POLYETHYLENE TIBIAL INSERT. 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 ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Discomfort; Emotional Changes; Failure of Implant; Implant Pain; Swelling/ Edema; Synovitis

  MAUDE report 16706695 ↗
• InjuryAug 17, 2022Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT HIS FEMALE PATIENT UNDERWENT A LEFT TKR AT CRYSTAL CLINIC, INC. IN AKRON, OHIO, WHICH IS LOCATED IN SUMMIT COUNTY. THIS WAS AN OPTETRAK LOGIC DEVICE. PATIENT BEGAN TO EXPERIENCE SWELLING IN AND AROUND THE LEFT KNEE. REVISION PERFORMED AT CRYSTAL CLINIC ON (B)(6) 2022. THE POLYETHYLENE INSERTS USED IN THE OPTETRAK DEVICE WERE DEFECTIVE, LEADING TO EARLY ASEPTIC LOOSENING.

  Patient problems: Aseptic loosening; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 15246451 ↗
• InjuryOct 8, 2019Loose or Intermittent Connection; Naturally Worn

  SURGERY WAS A POLY EXCHANGE ON (B)(6) 2019. THE 15 MM THAT CAME OUT WAS WORN ANTERIOR AND ON THE POST. PRIMARY SURGERY DATE WAS (B)(6) 2018. PATIENT HAD LAXITY. IMPLANTED A 19 MM PS INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 9168451 ↗

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