Optetrak Logic 02-010-03-0340Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862158130), received between Oct 7, 2019 and Jan 21, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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.

• InjuryJan 21, 2025Unstable; Unstable

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 4 YEARS 5 MONTHS POST INITIAL OPERATION. PATIENT PRESENTED TO OFFICE COMPLAINING ABOUT THEIR TOTAL KNEE REPLACEMENT. THE PATIENT REPORTED PAIN, INSTABILITY, AND DISSATISFACTION. THE PATIENT HAS RECALLED A TIBIAL POLY INSERT. THE PATIENT UNDERWENT A RIGHT KNEE REVISION, A FEMORAL COMPONENT REVISION, AND A POLY REVISION WAS PERFORMED DUE TO KNEE INSTABILITY. THE PATIENT WAS REVISED TO FEMORAL CC REVISION COMPONENT AND PSC POLY IMPLANT. THE SURGEON WANTED TO UPSIZE THE FEMUR COMPONENT FOR SIZING AND TO CLOSE THE EXTENSION GAP KNOWING IT IS OFF-LABEL WHEN KEEPING THE CURRENT TIBIA IMPLANT SIZE. THE TIBIA COMPONENT WAS WELL FIXED, AND THE SURGEON TRAILED THE REVISION SIZES. THE SURGEON WAS HAPPY WITH THE ARTICULATION AND STABILITY. THE PATIENT WAS IMPLANTED WITH THE CC REVISION FEMORAL COMPONENT AND NEW PSC POLY. THE PATIENT LEFT THE OR STABLE.

  Patient problems: Joint Laxity; Osteolysis; Pain

  MAUDE report 21203725 ↗
• InjurySep 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE-USA. PATIENT ID: (B)(6). THIS PATIENT HAS A VERIFIED RIGHT KNEE REPLACEMENT ON THE MASTER LIST WITH DR. (B)(6) AT (B)(6). NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. OPERATIVE REPORT FROM REVISION SURGERY ATTACHED. NO FURTHER INFORMATION. SERIAL NUMBER, ITEM NUMBER AND FULL DESCRIPTION: (B)(6), 02-012-49-4013 - LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K111400. CONCOMITANTS: (B)(6), 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; (B)(6), 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4; (B)(6), 200-02-32 - THREE PEG PATELLA 32MM.

  Patient problems: Discomfort; Pain; Synovitis

  MAUDE report 20138641 ↗
• InjuryAug 7, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 101 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, ASEPTIC LOOSENING AND DEBONDING OF THE FEMORAL COMPONENT, DAILY KNEE PAIN AND DISCOMFORT, LIMITED DAILY ACTIVITIES AND IMPACTED QUALITY OF LIFE. 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; Discomfort; Osteolysis; Pain

  MAUDE report 19927699 ↗
• InjuryJan 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY EIGHT YEARS POST INITIAL RIGHT TKA, THE 61 Y/O MALE PATIENT WAS REVISED DUE TO LOOSE FEMORAL COMPONENT. PATIENT RIGHT KNEE WAS REVISED DUE TO LOOSE FEMORAL COMPONENT OF HIS PRIMARY TOTAL KNEE. ONCE THE DOCTOR ASSESSED THE PATIENT'S IMPLANTS IN SURGERY, THE PATIENT ALSO HAD A LOOSE TIBIAL COMPONENT. PATIENT'S FEMORAL AND TIBIAL COMPONENTS WERE EXPLANTED AND EXACTECH KNEE REVISION IMPLANTS WERE RE-IMPLANTED. PATIENTS PATELLA IMPLANT WAS LEFT ALONE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18480350 ↗
• InjurySep 5, 2023Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 10 YEARS POST OP INITIAL RIGHT TKA, THIS 65 Y/O FEMALE PATIENT WAS REVISED DUE TO LOOSENING. PATIENT RETUNED TO SURGEONS OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT UNDERWENT A COMPLETE KNEE REVISION TO A COMPETITORS DEVICE. LONGER SURGERY AND A COMPLETE REVISION WAS NECESSARY DUE TO LOOSE PRIMARY EXACTECH IMPLANTS. DEVICES ARE NOT RETURNING - THE IMPLANTS WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. UNABLE TO OBTAIN X-RAYS. IMAGES ATTACHED.

  Patient problems: Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17682369 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, PATIENT PRESENTED WITH PAIN AND EXTENSION PROBLEM. AFTER CHECKING, SURGEON DECIDED TO REVISE THE FEMORAL COMPONENT. PATIENT WAS REVISED TO A SIZE 4 PS FEMUR AND 9MM PS LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED BY THE HOSPITAL.

  Patient problems: Pain

  MAUDE report 11690438 ↗
• InjuryFeb 12, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O (BMI=30), MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2014. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2015, APPROXIMATELY 10 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO RANGE OF MOTION (STIFFNESS). 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: Failure of Implant

  MAUDE report 9702685 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2014. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2015, APPROXIMATELY 12 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); 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: Bacterial Infection

  MAUDE report 9700404 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  REVISION OF KNEE COMPONENTS: REASON NOT REPORTED.

  Patient problems: No Information

  MAUDE report 9161666 ↗

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