Optetrak Logic 02-012-45-5040Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862004048), received between Aug 23, 2024 and Aug 15, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT WHO IS 10 YEARS POST RIGHT TOTAL KNEE REPLACEMENT. OVER THE PAST SEVERAL MONTHS HE IS DEVELOPING INCREASING PAIN AND SWELLING. HIS X-RAYS SHOWED OSTEOLYSIS UNDER THE TIBIAL PLATEAU WITHOUT ANY OTHER OBVIOUS SIGNS OF LOOSENING IN THE FEMUR OR PATELLA. THERE DID APPEAR TO BE MODERATE WEAR IN THE POLYETHYLENE LINER. DUE TO THE PATIENT¿S INCREASING PAIN AND DEBILITATION, ALONG WITH THE X-RAY SHOWING SIGNS OF OSTEOLYSIS, THEY WERE DETERMINED TO BE A CANDIDATE FOR RIGHT TOTAL KNEE REVISION. INTRAOPERATIVE FINDINGS REVEALED SIGNIFICANT WEAR OF THE MEDIAL ASPECT OF THE POLY LINER WITH SOME PITTING POSTERIOR MEDIALLY. THE TIBIAL COMPONENT WAS NOT OBVIOUSLY LOOSE BUT WAS EASILY REMOVED. THERE WERE ALSO SIGNIFICANT OSTEOLYTIC LESIONS PRIMARILY LATERALLY WHICH WERE CONTAINED AND DID NOT SIGNIFICANTLY AFFECT THE SUPPORTIVE NATURE OF THE BONE. THE FEMORAL COMPONENT WAS WELL FIXED BUT WAS REVISED TO ALLOW FOR CONSTRAINED CONDYLAR IMPLANT. THE PATELLAR COMPONENT WAS WELL FIXED AND LEFT IN PLACE. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THERE WERE NO COMPLICATIONS.

  Patient problems: Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 22814144 ↗
• InjuryJun 23, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH INCREASING KNEE PAIN, A SENSE OF INSTABILITY, AND SWELLING. PLAIN RADIOGRAPHS REVEALED POLYETHYLENE WEAR, LOOSENING OF BOTH THE FEMORAL AND TIBIAL COMPONENTS, AND OSTEOLYSIS AFFECTING BOTH BONES. DURING THE REVISION PROCEDURE, A FEMORAL AND TIBIAL BONE DEFECT WAS IDENTIFIED CONSISTENT WITH AORI TYPE 2B. THERE WAS ALSO A SIGNIFICANT PATELLAR DEFECT AND A NOTABLE SOFT-TISSUE REACTION CHARACTERIZED BY SYNOVITIS. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION. THIS IS 1 OF 4 REPORTS.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 22312117 ↗
• InjuryNov 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 72 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, SYNOVITIS, AND OSTEOLYSIS. 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. 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: Osteolysis; Synovitis

  MAUDE report 20775996 ↗
• InjurySep 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2020, APPROXIMATELY 4 YEARS, 6 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2020- POSTOPERATIVE DIAGNOSIS: LOOSE LEFT TOTAL KNEE REPLACEMENT. THE POLYETHYLENE WAS REMOVED, THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE. IT¿S APPEARANCE LOOKED GOOD, HOWEVER, IT WAS NOTED TO BE LOOSE. THE TIBIAL COMPONENT WAS ALSO FOUND TO BE LOOSE AND REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20156449 ↗
• InjuryAug 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA (B)(4). PATIENT ID: (B)(6). 8/19/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 8/8/24. ATTACHED EMAIL AND REVISION OP REPORT. UPDATED AWARE DATE ON TIBIAL INSERT AND ADDED DEVICE INFORMATION FOR FEMUR, TIBIAL TRAY, AND PATELLA BASED ON NEW INFORMATION RECEIVED. PREOPERATIVE DIAGNOSIS INDICATED FAILED LEFT TOTAL KNEE ARTHROPLASTY DUE TO POLYETHYLENE WEAR. POSTOPERATIVE DIAGNOSIS INDICATED LEFT TOTAL KNEE ARTHROPLASTY DUE TO POLYETHYLENE WEAR AND EARLY LOOSENING. INDICATION FOR PROCEDURE: (B)(6) IS A 79-YEAR-OLD WHO UNDERWENT A PRIOR TOTAL KNEE ARTHROPLASTY WITH A RECALLED PROSTHETIC DEVICE. DUE TO CONCERNS FOR EARLY LOOSENING AND EARLY POLYETHYLENE WEAR, THE PATIENT WAS OFFERED REVISION TOTAL KNEE ARTHROPLASTY IN ITS ENTIRETY. INTRAOPERATIVE FINDINGS: SIGNIFICANT OSTEOLYSIS, EARLY LOOSENING OF COMPONENTS AND SIGNIFICANT POLYETHYLENE WEAR OF THE PATELLA COMPONENT AND TIBIAL LINER. BRIEF DESCRIPTION OF OPERATIVE PROCEDURE: A PARAPATELLAR ARTHROTOMY WAS PERFORMED AND IMMEDIATELY UPON MAKING THIS, A LARGE EFFUSION WAS ENCOUNTERED. THERE WERE POLYETHYLENE FRAGMENTS FLOATING WITHIN THE KNEE AND POLYETHYLENE WEAR NOTED OF THE PATELLAR COMPONENT AND TIBIAL LINER. SOME EA

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

  MAUDE report 20054105 ↗
• InjuryAug 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ UNITED STATES (MDL NO. 3044) RELATED CASE FOR REVISION OF RK DOCUMENTED ON (B)(4). IT WAS REPORTED THAT APPROXIMATELY 119 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, INSTABILITY, RECURRENT EFFUSIONS, EXTENSIVE SYNOVITIS, OSTEOLYSIS, ASEPTIC LOOSENING OF FEMUR AND TIBIA, AND GROSSLY LOOSE PATELLA; DELAMINATED POLYETHYLENE DEBRIS. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 20052762 ↗