Optetrak Logic 02-012-45-3535Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862003997), received between Jan 19, 2023 and Jan 23, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT EXPERIENCED PAIN IN THEIR KNEE. DURING EXAMINATION, INSTABILITY WAS FOUND. IN THE RADIOLOGICAL STUDY, THE IMAGE IS COMPATIBLE WITH PET WEAR, WEAR OF THE PATELLAR COMPONENT, MASSIVE OSTEOLYSIS IN RELATION TO THE TIBIAL COMPONENT, AND TESTS COMPATIBLE WITH ASEPTIC DISIMPLANTATION. NORMAL BLOOD METAL LEVELS. THE PATIENT WAS REVISED APPROXIMATELY 5 YEARS AND 1 MONTH POST THEIR INITIAL KNEE SURGERY. NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Granuloma; Joint Laxity; Osteolysis; Pain

  MAUDE report 21221888 ↗
• InjuryJan 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4 YEARS AND 10 MONTHS POST INITIAL TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT EXPERIENCED PAIN IN THE OPERATED KNEE. DURING EXAMINATION, THE PATIENT HAD MULTIDIRECTIONAL INSTABILITY OF THE KNEE. IN RADIOLOGICAL STUDY, THE IMAGE WAS COMPATIBLE WITH POLYETHYLENE WEAR, WEAR OF THE PATELLAR COMPONENT, MASSIVE OSTEOLYSIS IN RELATION TO THE TIBIAL COMPONENT, AND TESTS COMPATIBLE WITH ASEPTIC DISIMPLANTATION. THE PATIENT HAD NORMAL BLOOD METAL LEVELS. IT WAS FURTHER NOTED THAT THE PATIENT EXPERIENCED SIGNIFICANT DISABILITY AND SURGICAL REVISION WAS PERFORMED TO AVOID INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Laxity; Osteolysis; Pain

  MAUDE report 21161427 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  LEGAL CASE-USA. PATIENT ID: (B)(6) + RIGHT KNEE. IT WAS REPORTED THAT DURING THE PATIENT'S RIGHT KNEE REVISION SURGERY AND WHILE REMOVING THE TIBIAL COMPONENT, AN INTRAOPERATIVE SURGICAL INTERVENTION WAS PERFORMED DUE TO A LARGE SECTION OF POSTERIOR PROXIMAL TIBIA BONE THAT WAS ADHERENT TO THE POSTERIOR ASPECT OF THE KEEL CREATING A FRACTURE DEFECT TO THE POSTERIOR PROXIMAL TIBIA UPON REMOVAL. IT WAS NOTED THAT THE LARGE BONE FRAGMENT CONTAINED POSTERIOR CAPSULAR SOFT TISSUE AND BLOOD SUPPLY AND WAS FREED FROM THE TIBIAL COMPONENT AND REAPPROXIMATED IN THE ANATOMIC POSITION. IT WAS NOTED THAT 70% OF THE PROXIMAL TIBIA REMAINED INTACT WITHOUT COMPROMISE AND NO DIAPHYSEAL EXTENSION. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL NO. (B)(6); 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T UDI NUMBER: (B)(4). 510(K) NUMBER: K101981 PRODUCT CODE: JWH.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 21079664 ↗
• InjuryDec 2, 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 THAT APPROXIMATELY 64 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SWELLING, STIFFNESS, ARTHROFIBROSIS S/P INITIAL SURGERY. 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; Joint Laxity; Joint effusion; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20820974 ↗
• InjuryNov 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 87 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, AMBULATION OR POSTURAL DIFFICULTIES, AND FAILURE OF IMPLANT. 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; Failure of Implant; Pain

  MAUDE report 20762344 ↗
• InjuryOct 28, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE: USA RELATED CASE (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2014. APPROXIMATELY 8 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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. REVISION OP REPORT ON (B)(6) 2022 PRINCIPAL DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT DUE TO MECHANICAL LOOSENING. POST-OP DIAGNOSIS: SAME SIGNIFICANT FIBRINOUS DEBRIS WAS ENCOUNTERED INTO THE JOINT WITH A TANDEM WHITISH COLOR THIS TISSUE WAS HIGHLY FRIABLE WAS FOUND THROUGHOUT THE SUPRAPATELLAR POUCH AS WELL AS IN THE GUTTERS. THIS WAS EXCISED AND THE KNEE IN ORDER TO FULLY DEBRIDED TO VISUALIZE ALL THE COMPONENTS THEN REMOVES SIMILAR DEBRIS FROM THE ANTERIOR INTERVAL AS WELL AS DID ARE NORMAL MEDIAL RELEASE. WE THEN REMOVED THE POLYETHYLENE INSERT WITH A SINGLE PRONG RETRACTOR. THE POLY WAS NOTED TO BE YELLOW WITH SIGNIFICANT PITTING AND LOSS OF THICKNESS IN THE MEDIAL LATERAL COMPARTMENT WITH CENTRAL PITTING AND ROUGHNESS NOTED ON BOTH THE M

  Patient problems: Joint Laxity

  MAUDE report 20548059 ↗
• InjuryOct 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A 69 YO MALE PATIENT, INITIAL RIGHT TOTAL ARTHROPLASTY IN (B)(6) 2016, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 7 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. SINCE (B)(6) 2023, THE PATIENT HAD SUFFERED FROM RIGHT KNEE PAIN: THE KNEE WAS SWOLLEN WHEN HE WALKED FOR 30 MINUTES, CYCLED, STOOD STATICALLY FOR MORE THAN 20 MINUTES OR DROVE. TAKING PAINKILLERS AND CORTISONE DID NOTHING TO CHANGE THIS SITUATION; THE PATIENT LAY OR SAT WITHOUT BEING ABLE TO DO ANY SPORT, GO OUT OR TRAVEL. HE COULD DO SOME LIMITED DOMESTIC CHORES: SHOPPING, HOUSEWORK AND GARDENING. ON (B)(6) 2024, THE PATIENT CONSULTED HIS SURGEON, WHO DECIDED TO OPERATE ON (B)(6) 2024. THE SURGEON PERFORMED A REVISION OF THE RIGHT TOTAL KNEE PROSTHESIS WITH AN ENLARGED SYNOVECTOMY AND BONE RECONSTRUCTION. THE ENTIRE PROSTHESIS WAS COMPLETELY REPLACED BY A SEMI-CONSTRAINED PROSTHESIS, DUE TO FEMORAL AND TIBIAL LOOSENING. THE SURGEON TOLD THE PATIENT THAT THE PROSTHESIS WAS DEFECTIVE. ON DISCHARGE, THE PATIENT WAS HOSPITALIZED FOR THREE WEEKS AT HOME WITH DRESSING AND PHYSIOTHERAPY. HE RESUMED DRIVING ON (B)(6) 2024, AND SOME ACTIVITIES IN (B)(6) 2024.

  Patient problems: Joint effusion; Osteolysis; Pain

  MAUDE report 20522681 ↗
• InjuryAug 23, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 112 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ASEPTIC TIBIAL LOOSENING, AND PAIN. 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: Osteolysis; Pain

  MAUDE report 20055973 ↗
• InjuryAug 22, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 99 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Osteolysis; Pain

  MAUDE report 20040048 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE 69 Y/O MALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THE TIBIAL COMPONENT WAS REMOVED, AND THE REMAINING CEMENT WAS THEN REMOVED FROM THE CUT SURFACE OF THE TIBIA UTILIZING A SAW, OSTEOTOMES AND A RONGEUR. DURING REMOVAL OF THE TIBIAL COMPONENT, THE POSTERIOR CONDYLE OF THE TIBIA WAS FRACTURED IN A PARTIAL ARTICULAR PATTERN BUT REMAINED STABLE DUE TO SOFT TISSUE ATTACHMENTS. CEMENT WAS THEN REMOVED FROM THE INTRAMEDULLARY CANAL OF THE TIBIA UTILIZING BURR, OSTEOTOMES, REVERSE CURETTES AND PITUITARY INSTRUMENTS. THE FRACTURE WAS PROVISIONALLY HELD WITH K WIRES AND TWO LAG SCREWS WERE PLACED WITH CANCELLOUS 4.0 SCREWS MEDIALLY AND LATERALLY TO AVOID THE TIBIAL COMPONENT KEEL AND STEM. ONCE THE SCREWS WERE PLACED, THE TRIAL TIBIA WAS PLACED TO ENSURE NO OBSTRUCTIONS DUE TO THE SCREWS. THE FRACTURE WAS STABLE WITH THIS FIXATION AND OTHER FIXATION OPTIONS WERE FELT TO NOT BE WORTHWHILE GIVEN THE FRACTURE EXTENT. FLUOROSCOPY CONFIRMED ACCEPTABLE FRACTURE ALIGNMENT AND HARDWARE POSITIONING.¿ THERE IS NO OTHER PATIENT DEMOGRA

  Patient problems: Bone Fracture(s)

  MAUDE report 17700639 ↗
• InjuryJan 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST OP THE INITIAL LEFT TKA, THIS 70 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT WAS COMPLAINING OF PAIN. PICTURES SHOW SCAR TISSUE/SYNOVIAL FLUID FROM THE POLY AND LOOSE FEMUR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY. DEVICE IS NOT RETURNING, HOSPITAL WILL NOT RELEASE.

  Patient problems: Failure of Implant

  MAUDE report 16207103 ↗