Optetrak Logic 02-012-44-1011Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862173409), received between Aug 7, 2020 and Jul 9, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 52 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR ECONOMICAL AND NON-ECONOMICAL DAMAGES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 19700971 ↗
• InjuryApr 17, 2023Mechanical Problem; Naturally Worn; Patient Device Interaction Problem; Mechanical Problem; Naturally Worn; Patient Device Interaction Problem

  AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT HAD BILATERAL TKAS ON (B)(6) 2017. THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH A FAILED LEFT TOTAL KNEE REPLACEMENT REFRACTORY TO CONSERVATIVE MANAGEMENT. IMAGING WAS CONSISTENT WITH FAILED LEFT KNEE ARTHROPLASTY - SHE HAD OSTEOLYSIS OF THE FEMUR AND A RECALLED IMPLANT. THE PATIENT'S LEFT KNEE WAS REVISED ON (B)(6) 2022. THERE WAS EXTENSIVE SYNOVITIS THROUGHOUT THE KNEE. A THOROUGH SYNOVECTOMY WAS PERFORMED. THE PATELLAR COMPONENT WAS LOOSE AND WAS REMOVED BY HAND. THE FEMORAL AND TIBIAL COMPONENTS WERE NOT GROSSLY LOOSE. THE FEMORAL IMPLANT WAS REMOVED WITH MINIMAL BONE LOSS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

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

  MAUDE report 16758709 ↗
• InjuryApr 13, 2023Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT HAD BILATERAL TKAS ON (B)(6) 2017. THE PATIENT WAS NOTED TO HAVE SOME DISCOMFORT IN THE RIGHT KNEE. THE PATIENT WAS SCREENED PRE-OPERATIVELY FOR INFECTION. BASED ON CLINICAL HISTORY, EXAM, AND LABORATORY DATA, THERE WAS NO CONCERN FOR INFECTION. GIVEN THE PATIENT'S PERSISTENT PAIN AND RECALL OF HER IMPLANT, DISCUSSION WAS HELD REGARDING REVISION ARTHROPLASTY. THE PATIENT'S RIGHT KNEE WAS REVISED ON (B)(6) 2023. AN EXTENSIVE SYNOVECTOMY OF THE MEDIAL GUTTER, LATERAL GUTTER, SUPRAPATELLAR POUCH, AND FAT PAD WAS PERFORMED. THE PATELLA WAS SUBLUXATED LATERALLY. THE POLYETHYLENE INSERT WAS REMOVED AND THERE WAS SIGNIFICANT DAMAGE. THERE WERE FREE PIECES OF SHEARED OFF POLYETHYLENE FLOATING. ADDITIONALLY THE POST HAD SIGNIFICANT DAMAGE AT ITS ANTERIOR ASPECT. THE FEMORAL COMPONENT WAS FOUND TO BE WELL FIXED ON THE LATERAL SIDE. ON THE MEDIAL SIDE THERE WAS SOME OSTEOLYSIS. USING A COMBINATION OF A REVISION SAWBLADE AS WELL AS OSTEOTOME, THE FEMUR WAS REMOVED EASILY. THERE IS NO CEMENT ON THE BACK OF THE FEMORAL IMPLANT WHEN IT WAS REMOVED. CEMENT WAS REMOVED FROM THE DISTAL FEMUR AND CANAL. BONY INVENTORY AFTER REMOVAL OF THE FEMORAL COMPONE

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

  MAUDE report 16732398 ↗
• InjuryFeb 28, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2013, WITH AN OPTETRAK LOGIC PSC POLYETHYLENE TIBIAL INSERT, UNDERWENT A REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 3 YEARS 11 MONTHS POST THE INITIAL PROCEDURE TO REMOVE THE FAILED POLYETHYLENE LINER. UPON INFORMATION AND BELIEF, THE PLAINTIFF¿S LEFT KNEE REVISION SURGERY WAS DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE DEFECTIVE POLYETHYLENE INSERT COMPONENT WITHIN THE OPTETRAK DEVICE. AS A DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE AS DESCRIBED HEREIN, THE PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES WHICH ALL REQUIRE ONGOING MEDICAL CARE. NO DEVICE RETURNS ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 16457449 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA LEGAL, ON (B)(6) 2017, PATIENT UNDERWENT A TKA ON HER LEFT KNEE AND WAS IMPLANTED WITH THE OPTETRAK DEVICE. ON (B)(6) 2017, JUST NINE (9) DAYS AFTER THE INITIAL IMPLANT, PATIENT WAS ADMITTED, AGAIN TO HOSPITAL WITH A SEVERE INFECTION OF THE LEFT KNEE REPLACEMENT, THE SAME KNEE WHERE PATIENT WAS IMPLANTED WITH THE DEVICE. ON (B)(6) 2017, PATIENT WAS TAKEN TO THE OPERATING ROOM FOR DEBRIDEMENT OF HER LEFT KNEE AND REMOVAL OF THE POLYETHYLENE OPTETRAK LOGIC PSC TIBIAL INSERT. AFTER REMOVAL OF THE PSC TIBIAL INSERT, PATIENT'S TREATING SURGEON REPLACED IT WITH AN ANTIBIOTIC SPACER. PATIENT REMAINED IN HOSPITAL FOR FURTHER OBSERVATION AND TREATMENT OF THE INFECTION FROM (B)(6) 2017, UNTIL (B)(6) 2017, AT WHICH TIME PATIENT WAS AGAIN TAKEN TO THE OPERATING ROOM FOR YET ANOTHER SURGERY. ON (B)(6) 2017, PATIENT LEFT KNEE WAS AGAIN DEBRIDED AND THE ANTIBIOTIC SPACER THAT HAD REPLACED THE OPTETRAK LOGIC PSC TIBIAL INSERT WAS THEN ITSELF REPLACED WITH ANOTHER POLYETHYLENE INSERT INTO PATIENT¿S OPTETRAK PSC TIBIAL INSERT. NO ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection

  MAUDE report 15651782 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2.5 YEARS POST INITIAL LEFT TKA, THIS (B)(6) Y/O FEMALE PATIENT HAD A REVISION DUE TO CHRONIC HYDRARTHROSIS OCCURRING AFTER SOMEWHAT PROLONGED WALKS. PATIENT HAD PE ISSUE AND PATIENT PAINFUL WHILE WALKING. THERE WAS EVIDENCE OF POLY WEAR. PATIENT WAS SLIGHTLY LAX, SURGEON EXPLAINED TO PATIENT, UNTIL PROVEN OTHERWISE, THAT SYNOVECTOMY IS NECESSARY WITH REPLACEMENT OF A SLIGHTLY THICKER INSERT (13 VS 11MM). THE WEAR MARKS ON THE CENTER CAM FOOT WERE REAL BUT RELATIVELY UNOBTRUSIVE. THE SYNOVIAL FLUID WAS NOT VERY ABUNDANT AND IT WAS PERFECTLY CLEAR. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION REPORTED. PHOTOS AND X-RAYS RECEIVED, THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14161187 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO OTHER CONDITIONS (UNSPECIFIED FAILURE). INITIAL SURGERY DATE WAS (B)(6) 2015. THIS PATIENT HAD BILATERAL KNEE ARTHROPLASTY, IT IS UNKNOWN WHICH SIDED WAS REVISED, THE DEVICES FOR THE LEFT KNEE WERE USED FOR THE COMPLAINT INVESTIGATION. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946419 ↗
• 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 10382114 ↗