Optetrak Logic 02-012-45-2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862003904), received between Mar 21, 2023 and Jul 20, 2026 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 8 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO MECHANICAL INSTABILITY AND PARTICLE DISEASE ASSOCIATED WITH PET WEAR. THE PATIENT WAS EXPERIENCING CONSTANT PAIN. REPORTED PAIN IN RELATION TO THE TIBIA RADIATING TO THE PRE-TIBIAL REGION. FEELING OF INSTABILITY WITHOUT FALLING TO THE GROUND. INCREASINGLY REPORTS PAIN AND INSTABILITY. PHYSICAL EXAMINATION NOTED A COLD KNEE, INTACT SKIN, MARKED PAIN OVER THE TIBIAL COMPONENT AND LATERAL TIBIAL PLATEAU, MEDIAL LAXITY WITH LIGAMENTOUS ENDPOINT, AND NON-TENSE JOINT EFFUSION. RADIOGRAPHS DEMONSTRATED OSTEOLYSIS OF THE MEDIAL TIBIAL PLATEAU AND MEDIAL FEMORAL CONDYLE. CT FINDINGS NOTED CYSTIC LESIONS INVOLVING BOTH TIBIAL PLATEAUS AND THE TIBIAL KEEL WITH EVIDENCE OF POLYETHYLENE WEAR. INTRAOPERATIVE FINDINGS INCLUDE METALLOSIS INFILTRATION OF QUADRICEPS AND PATELLAR TENDONS, SYNOVIAL HYPERTROPHY WITH FOREIGN-BODY GRANULOMATOUS TISSUE, POLYETHYLENE DEBRIS WITHIN JOINT EFFUSION, WEAR AND PARTIAL FRACTURE OF THE MEDIAL POLYETHYLENE INSERT, FREE POLYETHYLENE FRAGMENTS, CONTAINED LATERAL FEMORAL CONDYLE DEFECT (AORI 2B), CONTAINED LATERAL TIBIAL PLATEAU DEFECT (AORI 2

  Patient problems: Cyst(s); Joint Laxity; Joint effusion; Metal Related Pathology; Pain

  MAUDE report 25871599 ↗
• InjuryFeb 13, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA (TOTAL KNEE ARTHROPLASTY). THE PATIENT DEVELOPED LOOSENING OF THE DEVICE AND PAIN IN HER KNEE AND WAS REVISED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED. UNABLE TO OBTAIN PHOTOS OR X-RAYS. DEVICE WAS NOT AVAILABLE FOR RETURN; THE HOSPITAL WILL NOT ALLOW RELEASE. NO ADDITIONAL INFORMATION.

  Patient problems: Pain

  MAUDE report 24335952 ↗
• InjuryJul 9, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 77 YO FEMALE PATIENT WHO HAD A LEFT SIDE KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THEY HAD POOR PROSTHETIC EVOLUTION FOLLOWING THE IMMEDIATE POSTOPERATIVE PERIOD, WITH PERSISTENT PAIN AND RECURRENT JOINT EFFUSION. THE PATIENT PRESENTED TO THE EMERGENCY DEPT WITH INCREASED PAIN, ALONG WITH AUDIBLE PROSTHETIC CLICKING DURING CERTAIN MOVEMENTS AND JOINT EFFUSION. X-RAY REVEALED ASYMMETRY IN THE MEDIAL AND LATERAL JOINT SPACES BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, SUGGESTIVE OF POLYETHYLENE FAILURE. A BONE SCAN CONFIRMED LOOSENING OF THE PROSTHETIC COMPONENTS. THE SURGERY PERFORMED REVEALED EXTENSIVE GRAYISH PERIPROSTHETIC MATERIAL SUGGESTIVE OF METALLOSIS. THE POLYETHYLENE WAS REMOVED, REVEALING ABNORMAL WEAR IN THE POSTERIOR-LATERAL REGION, WHICH HAD RELEASED POLYETHYLENE DEBRIS INTO THE PATIENT'S SOFT TISSUE. ALL PROSTHETIC COMPONENTS WERE REMOVED, AS WELL AS ALL TISSUE SUGGESTIVE OF METALLOSIS EXCISED, AND A REVISION TOTAL KNEE REPLACEMENT OF A COMPETITOR¿S DEVICES WERE IMPLANTED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STA

  Patient problems: Aseptic loosening; Joint effusion; Metal Related Pathology; Pain

  MAUDE report 22458654 ↗
• InjuryMar 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 36 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE FINDINGS NOTED SIGNIFICANTLY LOOSE PATELLA AND TIBIAL COMPONENTS WITH BONE LOSS MEDIALLY AND A FRACTURED POLYETHYLENE ANTEROMEDIALLY AND POSTEROLATERALLY. INTRAOPERATIVELY IT WAS NOTED THE FEMUR DEMONSTRATED IT DID NOT APPEAR TO BE LOOSE. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21577334 ↗
• InjuryMar 7, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YRS POPSTOP THE INITIAL L TKA, THIS FEMALE PATIENT¿S LEFT KNEE WAS REVISED DUE TO POLY WEAR AND OSTEOLYSIS. THE INSERT WAS REMOVED, THE FEMUR AND TIBIA BOTH CHECKED AND FOUND TO BE LOOSE. PATIENT HAD SIGNIFICANT BONE LOSS AND NEEDED A DISTAL FEMORAL REPLACEMENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE HOSPITAL DISCARDED THE DEVICES.

  Patient problems: Osteolysis

  MAUDE report 21549840 ↗
• InjuryFeb 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 80 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, LIGAMENT DAMAGE, IMPLANT PAIN, 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. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Damage to Ligament(s); Implant Pain; Osteolysis

  MAUDE report 21325278 ↗
• InjuryJan 27, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 6 YEARS 7 MONTHS POST OP. PATIENT EXPERIENCED PROSTHESIS WEAR, LOOSENING, METAL RELATED PATHOLOGY AND OSTEOLYSIS. EVERYTHING WAS REVISED DUE TO WEAR ON PATELLA AND TIBIAL INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 21240658 ↗
• InjuryJan 13, 2025Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED VIA A LEGAL FILING, THAT A FEMALE PATIENT WHO HAD AN INITIAL RIGHT KNEE IMPLANT PROCEDURE ON (B)(6)2014 WITH A RECALLED DEVICE, UNDERWENT A REVISION DUE TO TIBIAL COMPONENT COMPLICATION APPROXIMATELY 2 YEARS 4 MONTHS POST THE INITIAL IMPLANT PROCEDURE. NO DEVICES ARE AVAILABLE FOR RETURN AS IT IS A LEGAL CASE. ADDITIONAL INFORMATION: THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THEY WERE INJURED AS A RESULT OF PREMATURE WEAR OF A POLYETHYLENE DEVICE. CLAIMS FROM SHORT FORM: FAILED RIGHT TOTAL KNEE IMPLANT, RIGHT KNEE REVISION FOLLOWED BY A LENGTHY TIME PERIOD FOR RECOVERY AND PHYSICAL THERAPY, JOINT PAIN, INSTABILITY/BALANCE ISSUES WHICH CAUSED SEVERAL FALLS, ONE FALL DUE TO KNEE IMPLANT CAUSED HEAD INJURY, SWELLING, RIGHT KNEE PAIN WITH SUB

  Patient problems: Implant Pain; Inflammation; Joint Laxity; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 21145281 ↗
• InjuryJan 6, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2018. APPROXIMATELY 3 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2021. PATIENT EXPERIENCED PROSTHESIS WEAR, FRACTURE, PATELLAR LOOSENING, SCAR TISSUE, SYNOVITIS, IMPLANT PAIN, OSTEOLYSIS AND FAILURE OF IMPLANT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. PER THE REVISION OPERATIVE REPORT, ¿THE PATELLAR COMPONENT WAS LOOSE,¿ AND ¿THE TIBIAL POLYETHYLENE WAS WORN POSTERIORLY AND WAS FRACTURED POSTERIORLY.¿ ADDITIONALLY, THERE WAS NOTED TO BE ¿WEAR OF THE SUPERIOR POSTERIOR ASPECT OF THE TIBIAL TRAY FROM CONTACT WITH THE FEMORAL COMPONENT.¿ THIS INDICATES THAT METAL-ON-METAL PROSTHESIS WEAR WAS PRESENT. IT SHOULD ALSO BE NOTED THAT THE SURGEON ¿FELT A REVISION WAS NECESSARY TO REMOVE ALL OF THE OSTEOLYSIS,¿ AND STATED THAT THE FEMORAL AND TIBIAL COMPONENTS ¿LIKELY WOULD LOOSEN WITH THE AMOUNT OF OSTEOLYSIS PRESENT.¿ BASED ON THIS STATEMENT, IT DOES NOT APPEAR THAT THE IMPLANTS WERE CURRENTLY LOOSE, HOWEVER IT DOES INDICATE THAT OSTEOLYSIS WAS A SUBSTANTIAL REASON FOR REVISION. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABL

  Patient problems: Failure of Implant; Implant Pain; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 21080414 ↗
• InjuryJan 3, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 50 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR 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: Synovitis

  MAUDE report 21072762 ↗
• InjuryJun 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; 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, ASEPTIC LOOSENING, POLYETHYLENE INSERT FAILURE, OSTEOLYSIS, 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19567371 ↗
• InjuryMar 21, 2023Adverse 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

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 61 YO FEMALE PATIENT HAD AN WOUND INFECTION WITH SWELLING & DISCHARGE FROM RIGHT KNEE. THE WOUND CULTURES GREW STAPH HAEMOLYTICUS, ENTEROCOCCUS FAECALIS, CORYNEBACTERIUM. (INPATIENT/PROLONGED HOSPITALIZATION). THE ADVERSE EVENT DATE OF ONSET IS (B)(6) 2017. THE PATIENT WAS TREATED WITH MEDICATION. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2017.

  Patient problems: Bacterial Infection; Fluid Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 16587769 ↗