Optetrak Logic 02-012-44-3015Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10885862173584), received between Sep 26, 2019 and Jan 20, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Naturally Worn” (13 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2026Naturally Worn

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY SEVEN AND A HALF (7.5) YEARS AGO AND ALLEGES THAT THEY WILL NEED ANOTHER REVISION PROCEDURE DUE TO PROSTHESIS WEAR. IT IS UNKNOWN IF A REVISION HAS BEEN PLANNED. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO PATIENT IMPACT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24114344 ↗
• InjurySep 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 97 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. INITIAL SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20311882 ↗
• InjuryAug 27, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 51 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20076197 ↗
• InjuryAug 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 53 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. 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; Synovitis

  MAUDE report 20001264 ↗
• InjuryMay 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 34 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A SECOND REVISION PROCEDURE TO ADDRESS INFECTION, SWELLING, JOINT LAXITY, LOOSE FEMORAL COMPONENT, AND SYNOVITIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. 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; Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 19397331 ↗
• InjuryFeb 6, 2024Mechanical Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 9 YEARS AND 6 MONTHS 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: CHRONIC PERIOPROSTHETIC INFECTION. FINDINGS: SINUS TRACT THROUGH THE MEDIAL FASCIA OVER THE PROXIMAL MEDIAL TIBIA, SLIMY SYNOVIUM, LOOSE FEMORAL COMPONENT, WELL FIXED TIBIAL COMPONENT, PURULENT FLUID WITHIN THE SINUS TRACT. THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT AWAKE, ALERT, AND STABLE.

  Patient problems: Ambulation or Postural Difficulties; Ankylosis; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Loss of Range of Motion; Medical device site infection; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 18650046 ↗
• InjurySep 11, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT RECEIVED A TOTAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2014, IT IS STATED THAT, "IN THE YEARS FOLLOWING THE SURGERIES, EXPERIENCED PAIN, SWELLING, INSTABILITY, AND BONE LOSS ON BOTH KNEES CAUSED BY EARLY AND ACCELERATED POLYETHYLENE WEAR AND/OR COMPONENT LOOSENING." THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17718553 ↗
• InjuryJul 5, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY REVISION ON (B)(6) 2011 AND THEN APPROXIMATELY 11 YEARS, 1 MONTH LATER ON 16 (B)(6)2023 THE PATIENT EXPERIENCED A SECOND REVISION SURGICAL PROCEDURE. THE PATIENT WAS REVISED TO AN EXACTECH DEVICE. REVISION OPERATIVE REPORT OF (B)(6) 2023-POST OPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE REPLACEMENT SECONDARY TO WEAR OF THE BEARING SURFACE. FINDINGS: PATIENT WAS DOING WELL AND NOTICED INCREASING PAIN, INSTABILITY, AND CHRONIC DRAMATIC SWELLING OF THE KNEE THAT WAS MADE WORSE AFTER EXERCISE OR PROLONGED WALKING. PATIENT RECEIVED A RECALL LETTER. IN (B)(6) OF 2022 SEVERE MASSIVE CHRONIC SYNOVITIS A LARGE SYNOVIAL EFFUSION WAS NOTED. THE SYNOVIAL EFFUSION SHOWED A PREDOMINANCE OF MONOCYTES AND MACROPHAGES CONSISTENT WITH POLYETHYLENE WEAR AND HE WAS DIAGNOSED AS HAVING ACCELERATED POLYETHYLENE WEAR DUE TO OXIDATION OF THE POLYETHYLENE COMPONENT. UPON ENTERING THE KNEE, MASSIVE SYNOVITIS WAS NOTED. THE FEMORAL, TIBIAL, AND PATELLAR COMPONENTS WERE ALL WELL FIXED AND THERE WAS EXTREME SEVERE EROSION, DELAMINATION AND BREAKDOWN OF THE TIBIAL POLYETHYLENE INSERT. A NEW TRULIANT INSERT WAS IMPLANTED. DR

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17258779 ↗
• InjuryJun 30, 2023Adverse 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

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT ON AN UNKNOWN DATE. THEY SUBSEQUENTLY HAD RIGHT KNEE REVISION SURGERY ON (B)(6)2018. (B)(6)2018 OP REPORT POSTOPERATIVE DIAGNOSIS: LOOSENING OF THE TOTAL KNEE REPLACEMENT. EXPIRATION OF THE IMPLANTS REVEALED THAT THE FEMORAL COMPONENT WAS GROSSLY LOOSE. THE TIBIAL COMPONENT WAS WELL FIXED. THE PATELLAR COMPONENT WAS LOOSE. THE POLYETHYLENE LINER WAS INTACT. THE STABILITY OF THE KNEE REPLACEMENT WAS ADEQUATE. AFTER REMOVAL OF THE FEMORAL COMPONENT, AORI TYPE 2 BONE DEFICIENCY WAS OBSERVED. DISTAL AND POSTERIOR FEMORAL AUGMENTS WERE NECESSARY. AFTER REMOVAL OF THE PATELLAR COMPONENT, SEVERE BONE LOSS PRECLUDING REIMPLANTATION WAS OBSERVED. THE PATIENT WAS TRANSFERRED TO THE RECOVERY AREA IN STABLE CONDITION. 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; Insufficient Information

  MAUDE report 17238033 ↗
• InjuryMay 10, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, ON (B)(6) 2018, THE PATIENT UNDERWENT RIGHT KNEE REVISION SURGERY AND WAS IMPLANTED WITH A SECOND OPTETRAK LOGIC PSC POLYETHYLENE TIBIAL INSERT (SERIAL #: (B)(6)) WHICH WAS ALSO SUBJECT TO THE RECALL. ON (B)(6) 2022, APPROXIMATELY 3 YEARS AND 10 MONTHS AFTER THEIR INITIAL REVISION, THE PATIENT UNDERWENT RIGHT KNEE RE-REVISION SURGERY DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK LOGIC PSC 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; Balance Problems; Discomfort; Failure of Implant; Joint effusion; Swelling/ Edema; Synovitis

  MAUDE report 16904533 ↗
• InjuryMay 3, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2018 DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. HOWEVER, DURING THIS PROCEDURE, THE PATIENT WAS RE-IMPLANTED WITH A SECOND RECALLED OPTETRAK POLYETHYLENE TIBIAL INSERT (SERIAL #: (B)(6)). THE PATIENT EXPERIENCE PAIN IN THE RIGHT KNEE AND WILL LIKELY REQUIRE A RE-REVISION SURGERY AT A LATER DATE. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 16860210 ↗
• InjuryMar 21, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT, INITIAL LEFT KNEE IMPLANTED WITH AN OPTETRAK INSERT MADE OF POLYETHYLENE ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021, APPROXIMATELY 5 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. AS A RESULT OF DEFENDANTS¿ FAILURE TO PROPERLY PACKAGE THE OPTETRAK DEVICE PRIOR TO DISTRIBUTION, THE POLYETHYLENE LINER PREMATURELY DEGRADED AND THE PLAINTIFF WAS REQUIRED TO UNDERGO REVISION SURGERY DUE TO SEVERE PAIN, SWELLING, AND INSTABILITY IN THE KNEE AND LEG. THESE INJURIES WERE CAUSED BY EARLY AND PREVENTABLE WEAR OF THE POLYETHYLENE INSERT AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS AND OTHER INJURIES. 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 PRESENTLY UNDIAGNOSED, WHICH A

  Patient problems: Pain

  MAUDE report 16584861 ↗
• InjuryMar 1, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE LEGAL DEPARTMENT THAT THIS MALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN, STIFFNESS, AND DISCOMFORT REQUIRING MEDICAL TREATMENT, MONITORING AND CARE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Emotional Changes; Failure of Implant; No Clinical Signs, Symptoms or Conditions; Osteolysis; Pain

  MAUDE report 16461237 ↗
• InjuryJan 27, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL RIGHT TKA, THIS MALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13373229 ↗
• InjuryMar 4, 2021Naturally Worn; Naturally Worn

  APPROXIMATELY 5.5 YR POSTOP THE INITIAL IMPLANT, THIS (B)(6) Y/O FEMALE PATIENT HAD KNEE PAIN SOFT TISSUE SWELLING OFTEN ON THROUGHOUT THE YEARS. THE SURGEON HAD THE PATIENT DO A NICKEL ALLERGY TEST WHICH CAME BACK POSITIVE FOR NICKEL ALLERGY. ON (B)(6) 2021 SHE WAS REVISED THE KNEE TO S&N OXINIUM. THE FEMUR HAD A MEDIAL TILT THAT CREATED SIGNIFICANT WEAR MEDIALLY ON THE POLY INSERT, AS WELL AS NOTCHING OF THE PSC SPINE. THE PATIENT IS OBESE AND DIABETIC WITH RHEUMATOID ARTHRITIS. THE DEVICES WILL BE RETURNED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 11417277 ↗
• 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 LEFT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2015. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10946559 ↗
• InjuryDec 4, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2014. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946430 ↗
• InjuryAug 11, 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, MALE PATIENT WITH A BMI OF 29, UNDERWENT IMPLANTATION OF A INSERT TIBIA LOGIC PSC SZ3 15M. ON (B)(6) 2018, APPROXIMATELY 41 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING/ SYNOVITIS.

  Patient problems: Synovitis

  MAUDE report 10394346 ↗
• InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS 73 Y/O MALE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2018 WITH A TOTAL KNEE JOINT AND EXPERIENCED AN INFECTION APPROXIMATELY 11 MONTHS POSTOP. THE INSERT ONLY WAS SWAPPED WITH A NEW ONE AND THE JOINT WAS WASHED OUT. PATIENT WAS STABLE LEAVING THE OR. THERE WAS NO DELAY TO THE SURGERY. THE REP WAS PRESENT AT THE TIME OF THE SURGERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION PER HOSPITAL POLICY. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 9125739 ↗