Optetrak Logic 02-012-45-3020Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862003959), received between Mar 6, 2023 and Mar 5, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 reports).

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.

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.

• InjuryMar 5, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN, AMBULATION DIFFICULTIES, INSTABILITY, TIBIAL LOOSENING AND WEAR OF THE TIBIAL INSERT. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 7 YEARS AND 2 MONTHS AFTER INITIAL IMPLANTATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 24520053 ↗
• InjuryFeb 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 136 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND ASCEPTIC LOOSENING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED FAILURE OF TOTAL KNEE ARTHROPLASTY RIGHT KNEE SECONDARY TO ASCEPTIC LOOSENING WITH RECALLED EXACTECH TOTAL KNEE IMPLANTS. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21368242 ↗
• InjuryJan 24, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - USA PATIENT ID: DEBORAH ARNS RK REV CASE-(B)(4). AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. HE HAD RIGHT KNEE REVISION ON (B)(6) 2017, APPROXIMATELY 4 YEARS 9 MONTHS AFTER THEIR INITIAL REPLACEMENT SURGERY. POSTOPERATIVE DIAGNOSIS: FRACTURED POLYETHYLENE FAILURE WITH POLYETHYLENE DEBRIS RESULTING IN SEVERE SYNOVITIS. LOOSE FEMORAL COMPONENT WAS PRESENT. POST OP VISIT OF (B)(6) 2017 PATIENT HAS RESUMED ALL ACTIVITIES WITHOUT RESTRICTION. NO INSTABILITY OR PAIN, HAS VERY GOOD RANGE OF MOTION AND NO OTHER SYMPTOMS. 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; Joint Laxity; Synovitis

  MAUDE report 21233627 ↗
• InjuryJan 17, 2025Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD A RIGHT KNEE REVISION ON (B)(6)2015. APPROXIMATELY 2 YEARS AND 4 MONTHS AFTER THE REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6)2018. PATIENT EXPERIENCED PROSTHESIS WEAR, DISASSEMBLY, TIBIAL LOOSENING, FEMORAL LOOSENING, OSTEOLYSIS, PAIN AND SYNOVITIS. ON (B)(6) 2018 REVISION OP REPORT FOUND THAT BOTH THE FEMUR AND THE TIBIA WERE GROSSLY LOOSE AND EXTENSIVE BONE LOSS ON BOTH SIDES. THE PATELLA COMPONENT WAS SECURELY FIXED AND WAS NOT REVISED. THE PATIENT WAS AWOKEN AND TAKEN TO THE RECOVERY ROOM BREATHING SPONTANEOUSLY. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain; Synovitis

  MAUDE report 21182209 ↗
• InjuryJan 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 17 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, DISCOMFORT, AND IMPLANT PAIN. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21143269 ↗
• InjuryNov 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 2 YEARS AND 12 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20645285 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 91 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND DISCOMFORT, SWELLING, MOBILITY IMPAIRMENTS, BONE DETERIORATION, CYSTS; ONGOING MEDICAL CARE. INITIAL SURGERY AND 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: Ambulation or Postural Difficulties; Bone Fracture(s); Cyst(s); Discomfort; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20578695 ↗
• InjuryJun 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 111 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROTHESIS WEAR, POLYETHYLENE LINER WEAR, SYNOVITIS, ASEPTIC LOOSENING TIBIAL COMPONENT, AND FEMORAL COMPONENT LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Synovitis

  MAUDE report 19512783 ↗
• InjuryMar 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, WAS INITIALLY IMPLANTED ON (B)(6) 2015 WITH THE DEVICE WHICH FAILED PREMATURELY, CAUSING PAIN AND DIFFICULTY WALKING, AMONG OTHER INJURIES AND AILMENTS. AS A RESULT OF THE FAILURE OF THE DEVICE, PLAINTIFF WAS FORCED TO UNDERGO REVISION SURGERY ON (B)(6) 2018, APPROXIMATELY 3 YEARS 2 MONTHS POST INITIAL PROCEDURE, WHERE PLAINTIFF¿S DOCTOR EXPLANTED THE DEVICE AND IMPLANTED ANOTHER OPTETRAK LOGIC PSC TIBIAL INSERT WITH REVISION OF THE RIGHT TIBIAL COMPONENT. TELLINGLY, DURING THE FIRST REVISION PROCEDURE, PLAINTIFF¿S EXPLANTING SURGEON NOTED THAT PLAINTIFF¿S ¿BONE HAD COLLAPSED MEDIALLY AT THE PROXIMAL TIBIA AND THERE WAS OBVIOUS LOOSENING [OF THE DEVICE].¿ DUE TO THE COMPLICATIONS CAUSED BY THE FIRST POLYETHYLENE OPTETRAK LOGIC PSC TIBIAL INSERT WITHIN AN OPTETRAK LOGIC TKA SYSTEM, PLAINTIFF SPENT TIME IN THE HOSPITAL FOR TREATMENT AND RECOVERY FROM THE REVISION SURGERY. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

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

  MAUDE report 16485569 ↗