Optetrak Logic 02-012-45-1515Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862167330), received between Dec 14, 2022 and Mar 26, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 30 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, BUCKLING, AND POPPING. THE PATIENT STATED THAT SHE WAS NEVER TRULY HAPPY WITH HER KNEE. POST-OPERATIVELY, AND THAT IT HAD GOTTEN WORSE IN THE PAST YEAR. PRIOR TO REVISION. A PREOPERATIVE ASPIRATION WAS PERFORMED, WHICH WAS CONCERNING FOR INFECTION, WITH A POSITIVE SYNOVASURE AND SYNOVIAL WBC OF 11,800, ALTHOUGH CULTURES HAD SHOWN NO GROWTH. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. FINDINGS INDICATED SUBSTANTIAL INFLAMED AND HYPERTROPHIC SYNOVIAL TISSUE AND SCAR TISSUE. A POSTEROMEDIAL NONDISPLACED FRACTURE OF THE PROXIMAL TIBIA WAS ALSO DISCOVERED ONCE ALL THE CEMENT WAS EXTRACTED. THE SURGEON PERFORMED A RIGHT KNEE IRRIGATION AND DEBRIDEMENT, REMOVAL OF RIGHT TOTAL KNEE PROSTHESIS, AND FABRICATION AND PLACEMENT OF RIGHT KNEE ARTICULATING ANTIBIOTIC SPACER. THE PATIENT WAS AWAKENED AND SENT TO THE RECOVERY 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; Bone Fracture(s); Implant Pain; Joint Laxity; Medical device site infection; Scar Tissue; Synovitis; Unspecified Infection

  MAUDE report 21701630 ↗
• InjuryJan 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 3 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2016. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, DIFFICULTY WITH EVERYDAY ACTIVITIES, TROUBLE WALKING. 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. POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC FEMORAL AND TIBIAL LOOSENING. PROCEDURE: THERE IS SIGNIFICANT HYPERTROPHIC INFLAMMATORY SYNOVITIS A COMPLETE SYNOVECTOMY WAS PERFORMED. ON INSPECTION OF THE COMPONENTS OF THE PATELLA, COMPONENT WAS WELL FIXED. THE FEMORAL AND TIBIAL COMPONENTS WERE GROSSLY LOOSE THEY WERE EXTRACTED THERE IS NECROTIC BONE BENEATH THE COMPONENTS. RESIDUAL CEMENT AND FIBRINOUS DEBRIS WAS REMOVED. DEVICES WERE TRIALED AND THEN THE IMPLANTS SEATED. ALL WERE ASSESSED AND FOUND TO BE SATISFACTORY. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM. PATIENT WAS REVISED TO EXACTECH DEVICES.

  Patient problems: Ambulation or Postural Difficulties; Pain; Synovitis

  MAUDE report 21061313 ↗
• InjuryDec 14, 2022Naturally Worn; Adverse 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, AN OBESE PATIENT WAS REVISED; AFTER PRESENTING WITH SIGNIFICANT PAIN AND OSTEOLYSIS. RIGHT KNEE FEMUR, TIBIA AND POLY COMPONENTS WERE REMOVED AND REVISED TO A COMPETITOR¿S DEVICES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. THE DEVICES WILL NOT BE RETURNED AS THEY WERE SAVED FOR PATIENT. NO EXACTECH INSTRUMENTS WERE USED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 15983651 ↗