Optetrak Logic 02-012-49-3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10885862159311), received between Sep 24, 2022 and Jul 1, 2024 — classified as 15 injuries.

The most frequently reported specific device problem is “Naturally Worn” (15 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  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. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19650319 ↗
• InjuryJun 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 5 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE LINE EXCHANGE AND LYSIS OF ADHESIONS SECONDARY TO ARTHROFIBROSIS. PATIENT EXPERIENCES PAIN AND DISCOMFORT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19521265 ↗
• InjuryJun 11, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 109 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Balance Problems; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain

  MAUDE report 19515357 ↗
• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 55 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19345381 ↗
• InjuryMar 18, 2024Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58 YO FEMALE PATIENT, INITIAL RIGHT TKA IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 8 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2024. THE PATIENT UNDERWENT A POLY INSERT AND PATELLA IMPLANT SWAP. THEY WERE REVISED TO A TRULIANT CRC TIBIAL INSERT SZ 3.5, 10MM SN: (B)(6), OPTETRAK 3 PEG PATELLA 29MM SN: (B)(6). THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. THEY WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. X-RAYS AND DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 18927444 ↗
• InjuryOct 25, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST OP INITIAL RIGHT TKA, THIS 72 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR. LINER WAS EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISCARDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18007485 ↗
• InjuryAug 29, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL RIGHT TKA, THIS FEMALE PATIENT WAS REVISED DUE TO POLY WEAR. ALL IMPLANTS WERE REMOVED DUE TO EXCESSIVE BONE LOST. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS ATTACHED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING - DISPOSED.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 17642048 ↗
• InjuryAug 2, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 8 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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) 2023: DIAGNOSIS: FAILED TIBIAL INSERT RIGHT KNEE. THERE WAS SIGNIFICANT AMOUNT OF SYNOVITIS AND AN EFFUSION. THERE WAS SYMMETRIC WEAR POSTERIORLY ON BOTH THE MEDIAL AND LATERAL ASPECT OF THE INSERT. THERE WAS OBVIOUS DELAMINATION. IT WAS WORSE MEDIALLY THAN LATERALLY. THERE WAS NO LOOSENING OR ANY OSTEOLYSIS. THERE IS NO EVIDENCE OF INFECTION AND THE JOINT FLUID HAD A STRING SIGN AND WAS ALSO SENT OUT FOR CULTURE. THE PATIENT WAS THEN TRANSFERRED TO GURNEY AND TAKEN TO THE RECOVERY ROOM. NO COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 17443071 ↗
• InjuryJul 12, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL RIGHT TKA, THE MALE PATIENT NEEDED TO BE REVISED TO A FULL REVISION KNEE DUE TO POLY WEAR AND METALLOSIS. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED AT THE HOSPITAL.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 17308011 ↗
• InjuryMay 11, 2023Naturally Worn; Naturally Worn

  REVISION OP REPORT- DIAGNOSIS: FAILED TIBIAL INSERT RIGHT KNEE. THERE WAS SIGNIFICANT AMOUNT OF SYNOVITIS AND AN EFFUSION. THERE WAS SYMMETRIC WEAR POSTERIORLY ON BOTH THE MEDIAL AND LATERAL ASPECT OF THE INSERT. THERE WAS OBVIOUS DELAMINATION. IT WAS WORSE MEDIALLY THAN LATERALLY. THERE WAS NO LOOSENING OR ANY OSTEOLYSIS. THERE IS NO EVIDENCE OF INFECTION, AND THE JOINT FLUID HAD A STRING SIGN AND WAS ALSO SENT OUT FOR CULTURE. THE PATIENT WAS THEN TRANSFERRED TO GURNEY AND TAKEN TO THE RECOVERY ROOM. NO COMPLICATIONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

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

  MAUDE report 16916613 ↗
• InjuryApr 7, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST OP THE INITIAL LEFT TKA, THIS 76 Y/O MALE PATIENT WAS REVISED DUE TO COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR LEFT TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION LEFT TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT HAS REVISION SURGERY ON (B)(6) 2023. THE PATIENT UNDERWENT A LEFT TKA TIBIAL INSERT POLY SWAP AND PATELLA SWAP. THE PATIENT LEFT THE OR STABLE. REPORTED EVENT NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. PRODUCT NOT RETURNING: THE IMPLANT WAS SENT TO THE LAB AND LEGAL AT THE HOSPITAL. EBI, X-RAYS AND IMAGES ATTACHED.

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

  MAUDE report 16700445 ↗
• InjuryMar 28, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A MALE PATIENT, WHO HAD AN INITIAL LEFT TOTAL KNEE REPLACEMENT ON (B)(6), 2013, AND WAS IMPLANTED WITH OPTETRAK LOGIC DEVICES, UNDERWENT A REVISION PROCEDURE ON (B)(6), 2020, APPROXIMATELY 6 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. FOLLOWING A PERIOD OF POST-IMPLANTATION RECOVERY, AND FOR YEARS AFTER THE REPLACEMENT SURGERY, THE PATIENT¿S KNEE DEVICE PERFORMED AS EXPECTED. THE PATIENT UNDERWENT REVISION OF LEFT KNEE DEVICE SECONDARY TO COMPLETE POLYETHYLENE LINER WEAR RESULTING IN ASEPTIC LOOSENING, FRACTURE OF THE LATERAL FEMORAL CONDYLE, AND OSTEOLYSIS REQUIRING SIGNIFICANT BONE GRAFTING AND AUGMENTED REVISION COMPONENTS. ADDITIONALLY, THE LEGAL BRIEF INDICATES THAT DESPITE UNDERGOING THE REVISION SURGERIES, THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT THEIR ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS THEIR QUALITY OF LIFE. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT, AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; METALLOSIS; SOFT TISSUE DAMAGE; INFECTION;

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Bone Fracture(s); Discomfort; Medical device site infection; Osteolysis; Pain

  MAUDE report 16628681 ↗
• InjuryJan 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL LEFT TKA, THIS 62 Y/O MALE PATIENT WAS REVISED DUE TO THE POLY DELAMINATING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. DEVICE IS NOT RETURNING, DISPOSED OF BY HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16112405 ↗
• InjuryOct 29, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THE 55 Y/O FEMALE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, AND STIFFNESS IN THEIR RIGHT KNEE. THE PATIENT HAD A PREVIOUS RIGHT PRIMARY TKA DONE ON (B)(6) 2015. AN EXAMINATION WAS DONE AND X-RAYS WERE PERFORMED AND REVIEWED. THE ORIGINAL POLY IMPLANT WAS SEARCHED IN THE RECALL DATABASE AND DID COME BACK AS AN AFFECTED POLY IN THE RECALL. THE PATIENT WAS SCHEDULED FOR A RIGHT KNEE REVISION POSSIBLE POLY SWAP. THEN, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. THE SURGEON OPENED THE KNEE JOINT, PERFORMED A SYNOVECTOMY, AND REMOVED SCAR TISSUE. THE SURGEON THEN EXAMINED THE IMPLANTS, NOTING THAT THE PATELLA HAD BEEN WORN. AN OSTEOTOME AND POLY REMOVAL TOOL WAS USED TO REMOVE THE POLY IMPLANT. THE IMPLANT SHOWED TO BE BROKEN AND IN PIECES POSTERIORLY. IT SHOWED DELAMINATION AND PITTING. THE POLY REMNANTS WERE REMOVED FROM THE KNEE JOINT AND THE KNEE WAS IRRIGATED WELL. THEN ATTENTION WAS GIVEN TO THE METAL FEMUR AND TIBIA IMPLANTS, THE SURGEON USED A TAMP/ DIS-IMPACTOR TOOL TO CHECK THE METAL IMPLANTS AND THEY SHOWED TO BE LOOSE. THE SURGEON THEN REMOVED ALL OF THE IMPLANTS WITHIN THE RIGHT KNEE, FEMUR, TIBIA, AND PATELLA. THE SURGE

  Patient problems: Failure of Implant

  MAUDE report 15694787 ↗
• InjurySep 24, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 76 YO MALE PATIENT WHO WAS INITIALLY IMPLANTED ON THE LEFT KNEE ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 YEARS 9 MONTHS POST THE INITIAL REVISION PROCEDURE DUE TO POLYETHYLENE WEAR SYNOVITIS. PATIENT REVISED WITH EXACTECH INSERT AND PATELLA. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Synovitis

  MAUDE report 15478584 ↗

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