Optetrak Logic 02-012-45-4030Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862004017), received between Sep 27, 2024 and Apr 17, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN. AS A RESULT, APPROXIMATELY SEVEN YEARS AND TEN MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. IT WAS NOTED THAT THE POLYETHYLENE IMPLANT HAD SIGNIFICANT WEAR, AND THE TIBIAL TRAY WAS FOUND TO BE LOOSE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: Pain

  MAUDE report 24913070 ↗
• InjuryApr 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 4 YEARS POST INITIAL OPERATION. SUBSEQUENTLY, THE PATIENT PRESENTED TO SURGEON WITH A LOOSE TIBIA AND PATELLA. SURGEON REMOVED A 38 PATELLA, A SIZE 4F/3T TIBIAL TRAY AND A 14 X 25 TIBIAL STEM. ALSO THE LINER WAS A SIZE 4/13MM CONSTRAINED PS INSERT. THE SURGEON REVISED TO A THE TIBIA TO A 4F/3T WITH A 16 X 80 STEM. THE PATELLA WAS REVISED TO A 41MM THREE PEG PATELLA. A 32 TIBIAL METAPHYSEAL CONE AND A. 4/19MM CONSTRAINED INSERT. THE PATIENT IS EXTREMELY ACTIVE AND DOES MANUAL LABOR FOR WORK. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; Joint Laxity; Loss of Range of Motion

  MAUDE report 21864780 ↗
• InjuryJan 29, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT, WHO HAD AN INITIAL KNEE IMPLANTED IN (B)(6) 2020, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 4 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. PAIN, JOINT EFFUSION AND PROSTHETIC INSTABILITY WITH RADIOLOGICAL FINDINGS OF OSTEOLYSIS IN RELATION TO THE TIBIAL AND FEMORAL COMPONENTS, PET WEAR AND OTHER TESTS WITH A DIAGNOSIS OF ASEPTIC LOOSENING OF THE KNEE PROSTHESIS. ELEVATED LEVELS OF METALS (CHROMIUM AND COBALT) IN THE BLOOD. PROSTHESIS AFFECTED BY HEALTH ALERT FOR ITS WITHDRAWAL FROM THE MARKET. SIGNIFICANT DISABILITY. NEED FOR SURGICAL INTERVENTION TO AVOID INJURY OR PERMANENT DISABILITY. THREAT TO LIFE. X-RAY IMAGES WERE PROVIDED. NO DEVICE IMAGES WERE PROVIDED.

  Patient problems: Deformity/ Disfigurement; Joint Laxity; Joint effusion; Osteolysis; Pain

  MAUDE report 21270410 ↗
• InjuryJan 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 102 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, DISCOMFORT, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, FAILED IMPLANT AND IMPLANT PAIN. 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Failure of Implant; Implant Pain

  MAUDE report 21183803 ↗
• InjuryNov 12, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 126 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Osteolysis

  MAUDE report 20667799 ↗
• InjuryOct 25, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 49 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, METALLOSIS, LOOSENING OF TIBIAL TRAY, SYNOVITIS, BILATERAL KNEE PAIN, SWELLING, LOSS OF RANGE OF MOTION, LIMITED MOBILITY, AND PAIN AND ANGUISH. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20536375 ↗
• InjurySep 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA (MDL NO. (B)(6)). PATIENT ID: (B)(6) + RIGHT KNEE. (B)(4) LK IS ASSOCIATED WITH THIS CASE. ON 9/24/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 9/17/2024. ATTACHED EMAIL, INITIAL OP REPORT/IMPLANT LOG, AND REVISION OP REPORT. ADDED DEVICE INFORMATION FOR FEMUR AND TIBIAL TRAY BASED ON NEW INFORMATION RECEIVED. REVISION OPERATIVE NOTES WERE PROVIDED. PREOP AND POSTOP DIAGNOSES INDICATED RIGHT FAILED TOTAL KNEE DUE TO RECALLED TOTAL KNEE ARTHROPLASTY EXACTECH SYSTEM WITH PERIPROSTHETIC FRACTURE OF RIGHT DISTAL FEMUR. HISTORY: HE HAD A FAILED RECALLED EXACTECH STEM WITH BALLOONING OSTEOLYSIS AND FEMORAL FRACTURE WITH OBVIOUS LOOSENING OF THE TIBIAL COMPONENT AND SIGNIFICANT OSTEOLYTIC CHANGES. PATIENT HAS PROBLEMS WITH THEIR ACTIVITIES OF DAILY LIVING AS WELL AS GOING UP AND DOWN STEPS, WALKING ANY SIGNIFICANT DISTANCE, GETTING INTO AND OUT OF A CAR, ETC. DESCRIPTION OF PROCEDURE: FEMORAL COMPONENT WAS EASILY REMOVED BY GRASPING IT WITH A KOCHER CLAMP. RESIDUAL CEMENT AND FIBROTIC DEBRIS WERE REMOVED FROM THE MEDIAL PLATEAU. TIBIAL COMPONENT WAS REMOVED WITH USE OF AN OSCILLATING SAW. THERE WAS SEVERE FEMORAL AND TIBIAL BONE LOSS. COMPLETE SYNOVECTOMY WAS PERFORME

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Distress; Emotional Changes; Osteolysis; Pain

  MAUDE report 20320292 ↗