Optetrak Logic 02-012-49-2509Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862159212), received between Oct 29, 2019 and Aug 7, 2024 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 129 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Emotional Changes; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19929638 ↗
• InjuryJun 6, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON AN UNKNOWN DATE. THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF THEIR LEFT TKA. UPON EXAMINATION, POLY WEAR AND OSTEOLYSIS AND POSSIBLE BONE DEFECTS/LOSS IS SEEN. THE PATIENT WAS REVISED ON (B)(6) 2024 AND THE POLY TIBIAL IMPLANT WAS SWAPPED. THE POLY TIBIAL IMPLANT WAS FRACTURED AND BROKEN POSTERIORLY. THE PIECES WERE REMOVED FROM THE JOINT AND THE JOINT/WOUND WAS IRRIGATED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19476116 ↗
• InjuryApr 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 63YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 5 YEARS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO FEMUR LOOSENING AND POLY WEAR. - EVERYTHING WAS REMOVED AND EXCHANGED TO A COMPETITOR¿S PRODUCT. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. THEY WERE DISPOSED OF BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 19112122 ↗
• InjuryJan 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 56 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 4 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO PATELLA WEAR AND THE DELAMINATION OF THE TIBIAL INSERT. THE LINER AND PATELLA WERE EXCHANGED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE STABLE FOLLOWING THE EVENT. NO X-RAYS OR IMAGING WAS AVAILABLE. THE PRODUCT IS NOT AVAILABLE FOR RETURN AS IT WAS DISPOSED OF BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18476365 ↗
• InjurySep 8, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS POST OP INITIAL LEFT TKA, THIS 79 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR. THE FEMORAL AND TIBIAL COMPONENTS ARE ALSO LOOSENING. ALL COMPONENTS WERE REPLACED WITH A REVISION KNEE SYSTEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE CONDITION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS ATTACHED, UNABLE TO OBTAIN X-RAYS.

  Patient problems: Aseptic loosening; Failure of Implant

  MAUDE report 17715958 ↗
• InjuryAug 29, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL RIGHT TKA, THIS 78 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR. LINER AND PATELLA WERE EXCHANGED. 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.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17646555 ↗
• InjuryJun 7, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6) 2018. PATIENT HAS CLAIMED THE FOLLOWING INJURIES: PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED THEIR MOBILITY AND QUALITY OF LIFE AND NECESSITATED A REVISION SURGERY AND THE RESULTANT PAIN FOLLOWING SURGERY AND RECUPERATION/REHABILITATION PERIOD AND PHYSICAL THERAPY. 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.

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

  MAUDE report 17077594 ↗
• InjuryJun 1, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT'S LINER AND PATELLA WERE REVISED ON (B)(6) 2023 DUE TO POLY WEAR. 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: Failure of Implant

  MAUDE report 17044542 ↗
• InjuryDec 1, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 8 YRS POSTOP THE INITIAL IMPLANT, THIS (B)(6) MALE PATIENT PRESENTED COMPLAINING OF PAIN. THE TIBIA AND FEMUR COMPONENTS BOTH WERE LOOSE. CR POLY WAS ALSO WORN. KNEE REVISED TO EXACTECH CCK. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS DUE TO HOSPITAL KEEP DEVICES PER HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12909919 ↗
• InjuryMay 31, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YR POSTOP THE INITIAL RTKA THIS (B)(6) Y/O FEMALE PATIENT EXPERIENCED POLY WEAR AND OSTEOLYSIS BEHIND FEMUR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 11910811 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem

  REVISION KNEE DUE TO INFECTION.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 9250312 ↗

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