Optetrak Logic 02-010-03-0240Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862158031), received between Feb 14, 2020 and Apr 21, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K111400); they may or may not involve this specific model.

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.

• InjuryApr 21, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 57 MONTHS AFTER A TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, INSTABILITY, JOINT LAXITY, PAIN, AND SWELLING/EDEMA. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21873006 ↗
• InjuryFeb 26, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 96 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, INSTABILITY, JOINT LAXITY, OSTEOLYSIS, PAIN, SWELLING/EDEMA, AND SYNOVITIS. 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: Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21471417 ↗
• InjuryJan 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 101 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, PAIN, SWELLING/EDEMA. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21208108 ↗
• InjuryDec 9, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY. THEN SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION SURGERY APPROXIMATELY 123 MONTHS AFTER THEIR PRIMARY PROCEDURE. THE PATIENT HAS EXPERIENCED PROTHESIS WEAR, SEVERE PAIN, OSTEOLYSIS, INSTABILITY, ASEPTIC LOOSENING, HAVING TO UNDERGO REVISION SURGERY. 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: Failure of Implant; Joint Laxity; Osteolysis; Pain

  MAUDE report 20878580 ↗
• InjuryAug 26, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA (MDL NO. 3044) RELATED CASE-(B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 87 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 15-AUG-2024 ADDITIONAL INCREMENTAL INFORMATION RECEIVED VIA EMAIL TO LEGAL (EMAIL ATTACHED). AFTER FIRST LK REVISION AND EXACTECH COMPONENTS EXPLANTED, PATIENT WAS IMPLANTED WITH SMITH & NEPHEW. IT IS DOCUMENTED THAT PATIENT HAD 3 REVISIONS AFTER THAT TO TREAT INFECTION.

  Patient problems: Failure of Implant; Joint effusion; Pain

  MAUDE report 20070688 ↗
• InjurySep 5, 2023Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015 DUE TO OSTEOARTHRITIS. APPROXIMATELY 7 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING, LEFT TOTAL KNEE. THERE WAS EXTENSIVE FRIABLE SYNOVITIS CONSISTENT WITH LOOSENING AND AN AGGRESSIVE SYNOVECTOMY WAS PERFORMED. THE SURGEON NOTED THE FEMUR WAS WIGGLING CLINICALLY AND WAS ABLE TO BE REMOVED BY HAND. UNDERNEATH THE CEMENT WAS FAIRLY EXTENSIVE CAVITARY DEFECTS AND THE MAJORITY OF THE LATERAL FEMORAL CONDYLE WAS HOLLOWED OUT AND A LARGE AREA OF FEMORAL METAPHYSIS WAS HOLLOWED OUT. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Insufficient Information; Pain; Scar Tissue; Synovitis

  MAUDE report 17681446 ↗
• InjuryDec 2, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YEARS POST INITIAL LEFT SIDE TKA, THE MALE PATIENT PRESENTED FOR A REVISION KNEE DUE TO FEMORAL LOOSENING. FEMUR DEBONDED FROM CEMENT DURING EXTRACTION. PATIENT RECEIVED FULL REVISION OF FEMUR COMPONENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15902490 ↗
• InjuryFeb 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6), THIS (B)(6), MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6)2013. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A LOGIC - CRUCIATE RETAINING - CEMENTED FEMORAL COMPONENT - LEFT - SIZE 4 (CATALOG 02-010-03-0240, SERIAL (B)(4)), LOGIC - FIT - CEMENTED TIBIAL TRAY - SIZE 4F/4T (CATALOG 02-012-45-4040, SERIAL (B)(4)), LOGIC - CRUCIATE RETAINING TIBIAL INSERT - SIZE 4 11MM SLOPE ++ (CATALOG 02-012-49-4011, SERIAL (B)(4)) AND STRYKER ANTIBIOTIC LOADED MEDIUM VISCOSITY BONE CEMENT (CATALOG 61971001, SERIAL (B)(4)). ON (B)(6) 2018, APPROXIMATELY 53 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING PATELLA. THE EXACTECH KNEE BRAND REMOVED UNAVAILABLE AND REPLACED WITH GII OVAL RESURFACING PAT 32MM.

  Patient problems: Failure of Implant

  MAUDE report 9715036 ↗
• InjuryFeb 14, 2020Appropriate Device Problem Term/Code Not Available

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2014. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2015, APPROXIMATELY 14 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO OTHER INDICATION FOR REVISION. THE FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (B)(6); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: No Information

  MAUDE report 9712668 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013