Optetrak Logic 02-012-45-2525Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862003935), received between Jul 30, 2024 and Jan 27, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2025Loosening 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 REVISION PROCEDURE TO ADDRESS LOOSENING, DISCOMFORT, AND INADEQUATE OSSEOINTEGRATION. 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: Discomfort; Inadequate Osseointegration

  MAUDE report 21245499 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 75 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND EXTENSIVE OSTEOLYSIS. POST OPERATIVE DIAGNOSIS NOTED MECHANICAL FAILURE OF RIGHT TOTAL KNEE REPLACEMENT. POST OPERATIVE FINDINGS NOTED COMPLETE MEDIAL POLYETHYLENE WEAR WITH FRACTURED POLYETHYLENE. INTRAOPERATIVELY THE SURGEON OBSERVED MODERATE EFFUSION, MEDIAL AND TIBIAL OSTEOLYSIS EXTENDING TO THE STEM OF THE PROSTHESIS AND THE ENTIRETY OF THE MEDIAL ASPECT OF THE FEMUR. IT WAS ALSO NOTED THERE WAS SYNOVITIS CONSISTENT WITH POLY WEAR EXTENSIVELY THROUGHOUT THE KNEE. UPON REMOVING THE TIBIA, THE SURGEON OBSERVED A FRACTURE THROUGH THE OSTEOLYSIS OF THE POSTERIOR MEDIAL PLATEAU. THE POSTERIOR MEDIAL VOID WAS FILLED WITH CEMENT AND HAD ADDITIONAL FIXATION OF THE REMAINING FRACTURE FRAGMENTS. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Failure of Implant; Joint effusion; Osteolysis; Synovitis

  MAUDE report 21150899 ↗
• InjuryDec 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Synovitis

  MAUDE report 21025754 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  LEGAL CASE ¿ USA (MDL NO. (B)(4) CASE (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 62 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR INTRAOPERATIVE BONE FRACTURE DURING REMOVAL OF TIBIAL TRAY COMPONENT. INITIAL SURGERY AND 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: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 20534300 ↗
• InjurySep 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TKA, THIS FEMALE PATIENT WAS BEING REVISED DUE TO A LOOSE FEMUR AND TIBIA. PATELLA WAS INTACT. THE TIBIAL BASEPLATE POLYETHYLENE SHOWED WEAR. SHOWED A SIGNIFICANT AMOUNT OF OSTEOLYSIS. A LARGE SOFT TISSUE RESECTION WAS DONE AND FRESH FROZEN SPECIMENS WERE SENT OFF. ASPIRATION SPECIMEN CAME BACK AS NEGATIVE WITH NO ORGANISMS SEEN. GENERALIZED INFLAMMATION WITH FIBROTIC TISSUE. THE PATIENT TOLERATED THE PROCEDURE WELL. NO COMPLICATIONS ENCOUNTERED. PATIENT WAS REVISED TO COMPETITOR DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION.

  Patient problems: Implant Pain; Osteolysis; Pain

  MAUDE report 20278216 ↗
• InjurySep 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 83 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LEFT KNEE PAIN; OSTEOLYSIS, LOOSENING OF FEMUR AND TIBIA, POLYETHYLENE WEAR ON THE TIBIAL INSERT. 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: Osteolysis; Pain

  MAUDE report 20223732 ↗
• InjuryAug 23, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 8 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THE PATIENT EXPERIENCED PAIN, SWELLING, STIFFNESS, LOSS OF MOTION, WEAKNESS, AND DIFFICULTY AMBULATING. 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. AS DIRECTED BY QA MANAGEMENT: THIS LEGAL COMPLAINT FOR POLYETHYLENE ISSUES OCCURRED IN THE US. THE EVENT DID NOT OCCUR IN, NOR IS IT REPORTABLE FOR AUSTRALIA, BRAZIL, CANADA, EEA/EU, JAPAN, TAIWAN, OR GREAT BRITAIN, EXCLUDING NORTHERN IRELAND. THEREFORE, ONLY THE US REPORTABILITY DETERMINATION WILL BE ASSESSED.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Loss of Range of Motion; Metal Related Pathology; Muscle Weakness/Atrophy; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20048272 ↗
• InjuryJul 30, 2024Mechanical Problem; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 70 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR SIGNIFICANT PAIN, SWELLING, DEPRESSION, DIFFICULTY SLEEPING, SCARRING, SIGNIFICANT WEIGHT LOSS, INABILITY TO STAND/WALK FOR EXTENDED PERIODS OR LENGTHS, AND REDUCED MOBILITY. DURING PLAINTIFF¿S REVISION SURGERY, SURGEONS NOTED NUMEROUS OBVIOUS BONY DEFECTS ON THE FEMUR AND TIBIA CAUSED BY THE DEFECTIVE OPTETRAK KNEE SYSTEM HAVING BEEN IMPLANTED IN PLAINTIFF. 94. PLAINTIFF¿S SURGEONS ALSO OBSERVED AND NOTED THAT PLAINTIFF¿S PATELLA HAD EXPERIENCED SIGNIFICANT OSTEOLYSIS (BONE LOSS), TO THE EXTENT THAT AT THE TIME OF PLAINTIFF¿S REVISION SURGERY, PLAINTIFF¿S ¿PATELLA WAS TOO THIN TO ACCEPT A NEW PATELLAR COMPONENT.¿6 THE DEGENERATION OF PLAINTIFF¿S PATELLA OCCURRED SUBSEQUENT TO THE INITIAL TKR WHEREIN DEFENDANTS¿ OPTETRAK DEVICE WAS IMPLANTED. PLAINTIFF¿S SURGEONS ALSO NOTED POSTERIOR AND DISTAL DEFECTS ON PLAINTIFF¿S TIBIA WHICH WERE NOT PRESENT OR OBSERVED PRIOR TO DEFENDANTS¿ OPTETRAK KNEE REPLACEMENT SYSTEM BEING IMPLANTED. ALL OF THE AFOREMENTIONED ISSUES OBSERVED BY PLAINTIFF¿S SURGEONS DURING

  Patient problems: Discomfort; Inflammation; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19860878 ↗