Optetrak Logic 02-012-47-2009Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862174246), received between Apr 21, 2022 and Mar 10, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2025Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY 74 MONTHS AFTER A PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT SURGERY, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT AND WILL LIKELY NECESSITATE A REVISION SURGERY IN THE FUTURE.

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

  MAUDE report 21562374 ↗
• InjuryJan 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 52 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, AMBULATION DIFFICULTIES, FAILED IMPLANT 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain

  MAUDE report 21183537 ↗
• InjuryAug 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAINFUL REVISION SURGERY; UNABLE TO WORK AND LOST INCOME; UNABLE TO OPERATE AT FULL CAPACITY WITH SIGNIFICANT LOSS OF INCOME UNTIL FULL RECOVERY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Distress; Emotional Changes; Pain

  MAUDE report 19973818 ↗
• InjuryMay 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 87 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A FUTURE PROCEDURE DUE TO POLYETHYLENE WEAR. THE PATIENT HAS REPORTED PAIN, SWELLING, AND INSTABILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19286465 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN 80 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE POLY WAS SWAPPED. RECALL POLY REPORTED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS OR DEVICE IMAGES PROVIDED. THE DEVICE WAS NOT AVAILABLE FOR RETURN. THE HOSPITAL KEPT THE DEVICE. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 17482038 ↗
• InjuryAug 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 74 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE RECALL. SURGEON PERFORMED A POLY SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DELAY/PROLONGATION. NO X-RAYS OR PHOTOS ARE AVAILABLE. DEVICE IS NOT RETURNING - HOSPITAL WOULD NOT ALLOW.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17478886 ↗
• InjuryJul 27, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO THE POLY RECALL. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

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

  MAUDE report 17410789 ↗
• InjuryJul 17, 2023Fracture; Naturally Worn; Insufficient Device Problem Information; Fracture; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOUCMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON 24 APR 2018. APPROXIMATELY 3 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON 11 AUG 2021. 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; Insufficient Information; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 17332158 ↗
• InjuryMay 30, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL LEFT TKA, THE 72 Y/O FEMALE PATIENT HAD A REVISION DUE TO THE POLY DEGRADATION ISSUES. PATIENT'S LINER WAS REVISED. PATIENT REVISED TO EXACTECH DEVICE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY HOSPITAL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17025744 ↗
• InjuryApr 13, 2023Fracture; Unstable; Fracture; Unstable

  AS REPORTED BY LEGAL NOTIFICATION, THE FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2016. THE PATIENT PRESENTED TO THE CLINIC WITH EVIDENCE OF AN EFFUSION. AT THAT TIME, WORKUP FOR INFECTION WAS NEGATIVE AND NORMAL X-RAY. OTHERWISE THE KNEE WAS STABLE. THE PATIENT RETURNED TO THE CLINIC WITH A LETTER STATING THAT SHE WAS ASSOCIATED WITH A RECALL AND AGAIN CONTINUED TO HAVE AN EFFUSION IN HER RIGHT KNEE. X-RAY DID SHOW SOME SLIGHT ASYMMETRY ON THE STANDING AP VIEW, AND THEN ESR AND CRP WERE NEGATIVE FOR INFECTION AND CT SCAN SHOWED NO SIGNIFICANT LYTIC LESIONS OR LOOSENING OF THE IMPLANTS. THEREFORE, THE METAL WAS DEEMED COMPETENT AND A POLYETHYLENE EXCHANGE WAS DISCUSSED. THE PATIENT WAS REVISED ON (B)(6) 2022. THERE WAS A LARGE KNEE EFFUSION WITH A LARGE ASSOCIATED POPLITEAL CYST. THERE WAS NO METALLOSIS. THERE WAS SIGNIFICANT HYPERTROPHY OF THE SYNOVIUM AND THIS SYNOVIUM WAS EXCISED ABOUT THE SUPRAPATELLAR POUCH AND MEDIAL AND LATERAL GUTTERS AND INTERCONDYLAR NOTCH. AFTER THIS WAS DONE, THE POLYETHYLENE WEAR WAS ISOLATED AND YOU COULD VISUALIZE FRACTURING OF THE ANTERIOR LIP OF THE MEDIAL COMPARTMENT OF THE POLYETHYLENE. THERE WAS PITTING AND DELAMINATION, DISCOLORATION AND

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Discomfort; Failure of Implant; Joint effusion; Muscle Weakness/Atrophy; Pain

  MAUDE report 16732014 ↗
• InjuryMar 14, 2023Naturally Worn; Naturally Worn

  THE REVISION REPORTED WAS LIKELY THE RESULT OF PRESUMED PROSTHESIS WEAR OF THE TIBIAL INSERT. HOWEVER, IMAGES OF THE REVISED INSERT AND PATELLA COMPONENTS DO NOT SHOW SIGNS OF EXCESSIVE PROSTHESIS WEAR INCONSISTENT WITH BEING IMPLANTED FOR APPROXIMATELY 5.25 YEARS. MALALIGNMENT OF THE COMPONENTS AT THE TIME OF IMPLANTATION AND/OR JOINT INSTABILITY CANNOT BE RULED OUT AS POSSIBLE CONTRIBUTING FACTORS IN THIS CASE BECAUSE NO RADIOGRAPHS WERE PROVIDED AND THE REVISED COMPONENTS WERE NOT RETURNED TO EXACTECH FOR EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 16539275 ↗
• InjuryApr 21, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL RIGHT TKA, THIS PATIENT PRESENTED IN CLINIC AFTER RECEIVING RECALL LETTER WITH PAIN, SWELLING, AND X-RAY INDICATION OF MEDIAL POLY WEAR. MAGNETIC RESONANCE IMAGING (MRI) DID NOT SHOW LOOSENING BUT DID SHOW SYNOVITIS. SURGEON PERFORMED REVISION. SURGEON USED A OSTEOTOME TO REMOVED THE OLD PINS WET. THE PATIENT¿S INSERT WAS EXCHANGED AND KNEE WASHED OUT. THE KNEE WAS STABLE WITH GOOD RANGE OF MOTION (ROM) WITH SAME SIZE POLY 9MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. SURGEON COMMENTED THAT THE INSERT DID NOT LOOK EXTREMELY WORN BUT DID HAVE SOME PITTING AND INDENTION. X-RAY RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO PATIENT WILL BE COLLECTING HER OLD POLY FOR EVALUATION.

  Patient problems: Cyst(s); Failure of Implant; Joint effusion; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 14167585 ↗

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