Optetrak Logic 02-012-48-3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862159281), received between Sep 20, 2022 and Nov 14, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (11 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.

• InjuryNov 14, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS AND 8 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLY WEAR. EVERYTHING WAS REMOVED. 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.

  Patient problems: Insufficient Information

  MAUDE report 20686362 ↗
• InjurySep 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 68 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245398 ↗
• InjuryMay 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 97 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, AND SWELLING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. 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; Joint effusion; Swelling/ Edema; Synovitis

  MAUDE report 19296598 ↗
• InjuryApr 22, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY EIGHT YEARS POST INITIAL RIGHT TKA, THE MALE PATIENT HAD A REVISION DUE TO POLY WEAR. EVERYTHING WAS REMOVED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISPOSED.

  Patient problems: Failure of Implant

  MAUDE report 19158411 ↗
• InjuryFeb 29, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 74 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 6 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLY AND PATELLA WEAR AND FEMORAL LOOSENING. THE TIBIAL INSERT WAS REVISED TO SIZE 3.5, 11MM. THE FEMORAL COMPONENT WAS REVISED TO SIZE 3.5. THERE WAS NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS AVAILABLE AS THE HOSPITAL DISPOSED OF THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18813195 ↗
• InjuryFeb 20, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL LEFT TKA, THE 68 Y/O FEMALE PATIENT WAS REVISED DUE TO OSTEOLYSIS AND POLYETHYLENE WEAR. ALL THE IMPLANTS WERE REMOVED AND REVISED IN TO COMPETITOR¿S PRODUCTS. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS ATTACHED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THEY WERE DISPOSED AT THE HOSPITAL.

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

  MAUDE report 18743261 ↗
• InjuryNov 21, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL LEFT TKA, THIS 73 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR AND FEMUR LOOSENING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISPOSED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18181908 ↗
• InjuryJul 24, 2023Fracture; Unstable; Naturally Worn; Insufficient Device Problem Information; Fracture; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2016. PATIENT HAS STATED PAIN FOR APPROXIMATELY 2 YEARS. PATIENT STATED THAT ON DOCTOR SAW HIS LEFT KNEE X-RAY AND CONFIRMED A FAILED POLY. PATIENT IS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2023. 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; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17377884 ↗
• InjuryJul 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST OP INITIAL RIGHT TKA, THIS FEMALE PATIENT WAS REVISED DUE TO SEVERE POLY WEAR. REVISED FROM CR TO PS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING / DISPOSED AT HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17266001 ↗
• InjuryFeb 24, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL RIGHT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2018, AND WAS IMPLANTED WITH AN OPTETRAK DEVICE, INCLUDING AN OPTETRAK LOGIC TIBIAL INSERT, SIZE 3.5, 9MM MADE OF POLYETHYLENE. PLAINTIFF UNDERWENT REVISION SURGERY OF HIS RIGHT KNEE ON (B)(6) 2022, APPROXIMATELY 4 YEARS POST INITIAL PROCEDURE. UPON INFORMATION AND BELIEF, THE LOOSE COMPONENTS AND OSTEOLYSIS IN PLAINTIFF'S RIGHT KNEE WAS DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. FOLLOWING REVISION SURGERY, PLAINTIFF CONTINUES TO BE LIMITED IN HIS ACTIVITIES OF DAILY LIVING. DESPITE UNDERGOING REVISION SURGERY, PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS LEFT KNEE WHICH LIMITS HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Implant Pain

  MAUDE report 16433780 ↗
• InjuryFeb 17, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED BY THE LEGAL DEPARTMENT, THAT THIS FEMALE PATIENT'S LEFT TKA WAS REVISED FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. PATIENT EXPERIENCES DAILY PAIN AND DISCOMFORT IN HER LEFT KNEE WHICH LIMITS HER ACTIVITIES OF DAILY LIVING AND IMPACTS HER QUALITY OF LIFE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aseptic loosening; Discomfort; Failure of Implant; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16395723 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP THE INITIAL LEFT TKA, THIS 75 Y/O MALE PATIENT WAS REVISED DUE TO DEEP INFECTION. NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 15454691 ↗

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