Optetrak Logic 02-012-51-4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862230492), received between Jul 8, 2021 and Nov 5, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Naturally Worn” (10 reports).

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

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 63 YO MALE PATIENT WHO HAD AN INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2021, AND WAS REVISED IN (B)(6) 2022, UNDERWENT A SECOND REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 2 YEARS POST THE (B)(6) 2022 PROCEDURE. EVERYTHING WAS REVISED DUE TO WEAR ON PATELLA AND TIBIAL INSERT AND WAS REPLACED WITH A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS. THEY WERE DISCARDED AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. FIRST REVISION REPORTED UNDER MDR# 1038671-2022-01234.

  Patient problems: Insufficient Information

  MAUDE report 20612627 ↗
• InjuryAug 15, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, RANGE OF MOTION, MENTAL AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ankylosis; Emotional Changes; Pain; Swelling/ Edema

  MAUDE report 19994582 ↗
• InjuryAug 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 52 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 19989844 ↗
• InjuryAug 13, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  LEGAL CASE - USA (MDL NO. 3044 (NGG) (MMH). RELATED CASE - (B)(4) RK REV 1, (B)(4) RK REV 2, (B)(4) RK PAIN. IT WAS REPORTED THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, DECREASED RANGE OF MOTION, MENTAL ANGUISH, EMOTIONAL DISTRESS, FEAR, LOSS OF ENJOYMENT OF LIFE, MEDICAL EXPENSES, AND FINANCIAL LOSSES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19977271 ↗
• InjuryFeb 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 5 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO PAIN AND SYNOVITIS. PROSTHESIS WEAR WAS INDICATED. X-RAYS AND DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain; Synovitis

  MAUDE report 18762996 ↗
• InjurySep 12, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE MALE PATIENT HAD ORIGINAL RIGHT REVISION KNEE PERFORMED ON (B)(6) 2018. THE PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF THEIR BILATERAL TKA'S. UPON EXAMINATION POLY WEAR AND OSTEOLYSIS IS EVIDENT. THE POLY IMPLANT WITHIN THE PATIENT IS INVOLVED IN THE RECALL. THE PATIENT WAS SCHEDULED FOR A REVISION RIGHT TKA POSSIBLE POLY SWAP ON (B)(6) 2023. THE PATIENT UNDERWENT A FULL KNEE REVISION TO COMPETITOR'S PRODUCTS. THE EXACTECH POLY SHOWED EARLY WEAR AND THE METAL IMPLANTS WERE LOOSE ON THE BONE. THERE WAS NO BREAKAGE OF DEVICE. THERE WAS A GREATER THAN 45 MINUTES SURGICAL DELAY BUT THERE WAS NO ADVERSE EVENTS AS A RESULT. PHOTOS AND IMAGES RECEIVED. THE DEVICE ARE NOT AVAILABLE FOR EVALUATION BECAUSE THE IMPLANTS ARE SENT TO THE HOSPITAL LAB AND THEN LEGAL.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 17733427 ↗
• InjuryJul 6, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YEARS POST OP INITIAL LEFT TKA, THIS 61 Y/O MALE PATIENT WAS REVISED DUE TO LOOSE METAL IMPLANTS AND POLY WEAR. THE PATIENT PRESENTED IN SURGEON OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA'S. THE PATIENT HAS RECALLED IMPLANTS IN BOTH KNEES. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION BILATERAL TKA POSSIBLE POLY SWAP VS FULL REVISION.

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

  MAUDE report 17265902 ↗
• InjuryMay 21, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT (B)(6), WAS IMPLANTED WITH A 02-012-51-4011-LOGIC CRC INSERTO 4-11, SERIAL NUMBER (B)(6), ON (B)(6) 2021. THE INSERT WAS MANUFACTURED ON (B)(6) 2018 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON (B)(6) 2018, AND WAS 3 YEARS SHELF AGE AT THE TIME OF IMPLANT. APPROXIMATELY TWO YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16971271 ↗
• InjuryJan 3, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS MALE PATIENT'S KNEE WAS REVISED APPROXIMATELY 1 YEAR POST OP DUE TO POLY WEAR, ALL IMPLANTS REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16088246 ↗
• InjuryOct 4, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL RIGHT TKA, THIS FEMALE PATIENT WAS REVISED DUE TO A SWOLLEN KNEE AND PAIN CAUSED DUE TO POLY WEAR FROM THE BAD BATCH OF POLY. INSERT AND PATELLA CHANGED. PATIENT REVISED TO EXACTECH DEVICE.

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

  MAUDE report 15537129 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE (B)(6) Y/O MALE PATIENT HAD A RTKA PROCEDURE DONE APPROXIMATELY 5 WEEKS AGO, SINCE THE PROCEDURE HIS INFECTIONS MARKERS HAVE INCREASED. THE REMOVAL OF LINER AND WASH OUT OF JOINT SPACE WAS COMPLETED APPROXIMATELY 2 WEEKS AGO. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT AVAILABLE FOR RETURN, DISPOSED BY HOSPITAL.

  Patient problems: Bacterial Infection

  MAUDE report 12137746 ↗