Optetrak Logic 02-012-51-3011Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862230416), received between Aug 16, 2021 and Jun 9, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Naturally Worn

  IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOOSENING, PROSTHESIS WEAR AND OSTEOLYSIS. AS A RESULT, THE PATIENT UNDERWENT A KNEE REVISION AN UNKNOWN AMOUNT OF TIME AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 25448286 ↗
• InjuryAug 18, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED STIFFNESS, PAIN, OSTEOLYSIS, FEMORAL AND TIBIAL IMPLANT LOOSENING, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. AS A RESULT, APPROXIMATELY TEN YEARS AND ONE-MONTH POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS REVISED TO COMPETITOR'S DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. THE PRODUCTS ARE NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 3 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 22829371 ↗
• InjuryJul 2, 2024Naturally Worn; Lack of Effect; Naturally Worn; Lack of Effect

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 54 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND SUFFERING, LIMITED MOBILITY, RESTRICTIONS IN DAILY ACTIVITIES, DIFFICULTY WALKING, EMOTIONAL DISTRESS, LOSS OF ENJOYMENT OF LIFE, AND LOST EARNINGS. 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; Emotional Changes; Pain

  MAUDE report 19659019 ↗
• InjuryJun 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY UNKNOWN MONTHS AFTER A TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19459173 ↗
• InjuryJul 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2015. APPROXIMATELY 7 YEARS AND 2 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6) 2022. THE PATIENT EXPERIENCES JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, POLYETHYLENE WEAR, SYNOVITIS, CONSTRAINED LINER REVISION. 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: Insufficient Information

  MAUDE report 17344471 ↗
• 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 02-012-51-3011-LOGIC TIB INSERT IMPL CRC, SZ 3, 11MM, SERIAL NUMBER: (B)(6) ON (B)(6) 2017. THE INSERT WAS MANUFACTURED ON 25-MAR-2016 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 25-MAR-2016 AND WAS NINE MONTHS SHELF AGE AT THE TIME OF IMPLANT. APPROXIMATELY SIX 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 16971169 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS 74 Y/O FEMALE PATIENT CALLED TO CONFIRM IF HER LINER WAS PART OF THE RECALL. SHE STATES SHE HAS HAD PAIN AND SWELLING IN HER KNEE FOR SEVERAL YEARS AND WAS TOLD BY HER SURGEON HER KNEE IS FINE AND THERE IS NOTHING ELSE HE CAN DO FOR HER. SHE WAS ALSO UPSET HER SURGEON DID NOT NOTIFY HER ABOUT THE RECALL AND WAS TOLD BY HIS OFFICE HER KNEE WAS NOT PART OF THE RECALL. "SHE NO LONGER CAN DRIVE DUE TO THE REVISED KNEE". HER LINER SERIAL # IS PART OF THE RECALL. PATIENT HAS NOT BEEN REVISED TO DATE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 16070796 ↗
• InjuryOct 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS MALE PATIENT'S LEFT KNEE WAS REVISED 2.5 YEARS POST OP. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15545410 ↗
• InjuryJun 10, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THE 78 Y/O MALE PATIENT HAD A REVISION FOR PRE-MATURE WEAR ON THE POLY-ETHYLENE. REPLACED POLY WITH A NEW, PRE-PACKAGED POLY. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTO RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 14656161 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, PATIENT HAD A REVISION DUE TO INFECTION. THIS IS THE 3RD REVISION OF THE PATIENT TO TREAT THE INFECTION FURTHERLY. IN THE LAST REVISION SURGERY, PATIENT HAS A CEMENT SPACER INSERTED IN THE TIBIAL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED TO HOSPITAL AS IT WAS DISPOSED BY THE HOSPITAL.

  Patient problems: Bacterial Infection

  MAUDE report 12329272 ↗