Optetrak Logic 02-010-03-0220Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862157997), received between Feb 12, 2020 and Jul 9, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 22457330 ↗
• InjuryFeb 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD BILATERAL KNEE REPLACEMENT WITH THEIR LEFT KNEE REPLACED ON (B)(6) 2016. THE PATIENT IS SCHEDULE TO HAVE LEFT KNEE REVISION ON (B)(6) 2023. THE REASON FOR REVISION HAS NOT BEEN PROVIDED. 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; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21424028 ↗
• 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 21240601 ↗
• 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 STAB

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

  MAUDE report 21080215 ↗
• InjuryDec 6, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 7 YEARS AND 1 MONTH AFTER INITIAL IMPLANT. PATIENT HAS EXPERIENCED PROSTHESIS WEAR, OSTEOLYSIS, SWELLING/ EDEMA, SYNOVITIS AND SCAR TISSUE. IT WAS REPORTED IN THE OPERATIVE NOTES EXPIRATION OF THE IMPLANTS REVEALED, PATELLA, FEMORAL AND TIBIAL BASEPLATE WEAR. ALSO NOTED IN THE OPERATIVE FINDING THE PATIENT WAS NOTED TO HAVE ARTHROFIBROSIS IN THE KNEE JOINT. COMPONENTS WERE NOT RETURNED TO EXACTECH FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. PATIENT WAS TAKEN FROM THE OPERATING ROOM TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity; Osteolysis; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20863608 ↗
• 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 LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2014. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2018, APPROXIMATELY 48 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY. THE 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: Failure of Implant

  MAUDE report 9703235 ↗

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