Optetrak Logic 02-012-49-5009Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862174611), received between Jul 31, 2022 and Jun 23, 2025 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2025Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH INCREASING KNEE PAIN, A SENSE OF INSTABILITY, AND SWELLING. PLAIN RADIOGRAPHS REVEALED POLYETHYLENE WEAR, LOOSENING OF BOTH THE FEMORAL AND TIBIAL COMPONENTS, AND OSTEOLYSIS AFFECTING BOTH BONES. DURING THE REVISION PROCEDURE, A FEMORAL AND TIBIAL BONE DEFECT WAS IDENTIFIED CONSISTENT WITH AORI TYPE 2B. THERE WAS ALSO A SIGNIFICANT PATELLAR DEFECT AND A NOTABLE SOFT-TISSUE REACTION CHARACTERIZED BY SYNOVITIS. THE PATIENT WAS REVISED TO 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 RETURN. NO FURTHER INFORMATION. THIS IS 1 OF 4 REPORTS.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 22312351 ↗
• InjuryApr 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A 63 YO MALE PATIENT, INITIAL RIGHT TKA IN (B)(6) 2017, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 7 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON WITH COMPLAINTS OF STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. THE PATIENT HAS A RECALLED POLY IMPLANT. THEY WERE SCHEDULED FOR A REVISION TKA, POSSIBLE POLY SWAP. THE PATIENT HAD REVISION SURGERY IN (B)(6) 2025 AND THE POLY IMPLANT AND PATELLA IMPLANT WERE SWAPPED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE SENT TO THE LAB AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT. SEE MDR# 1038671-2025-01804.

  Patient problems: Discomfort; Loss of Range of Motion; Pain

  MAUDE report 21857371 ↗
• InjuryFeb 12, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT A 63 YO MALE PATIENT, INITIAL LEFT TKA IMPLANTED IN (B)(6) 2017, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 7 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. THE PATIENT HAS A RECALLED POLYETHYLENE IMPLANT. THE PATIENT WAS SCHEDULED FOR A REVISION TKA POSSIBLE POLYETHYLENE SWAP. THE TIBIAL POLYETHYLENE IMPLANT AND A PATELLA IMPLANT WERE SWAPPED. THE POLYETHYLENE WAS BROKEN IN PIECES POSTERIORLY, THE PIECES OF THE IMPLANT AND POLYETHYLENE WERE REMOVED FROM THE WOUND SITE, AND THE KNEE JOINT WAS IRRIGATED WELL. THEY WERE REVISED TO A TIBIAL INSERT SZ 5, 10 MM, AND A 3 PEG PATELLA CEMENTED 38 MM. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE SENT TO THE LAB AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21363578 ↗
• InjuryJan 2, 2025Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2013 DUE TO END STAGE OSTEOARTHRITIS. APPROXIMATELY 2 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2015. PATIENT EXPERIENCED PROTHESIS WEAR, PAIN, SYNOVITIS, SCAR TISSUE, LOSS OF RANGE OF MOTION AND ANKYLOSIS. REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: FIBROUS ANKYLOSIS, RIGHT KNEE, WITH LOOSE FEMORAL COMPONENT. THE SURGEON NOTED THAT AFTER RESECTION OF THE POSTERIOR CRUCIATE AND NOTCH, THE COMPONENT APPEARED TO BE INTACT, BUT ON GENTLE MANIPULATION IT EASILY LOOSENED REMOVING THE METAL FROM THE OVERLYING CEMENT THAT STAYED ON THE BONE. THE TIBIAL BASE WAS STILL INTACT AND LEFT ALONE. 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: Ankylosis; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain; Scar Tissue; Synovitis

  MAUDE report 21055396 ↗
• InjuryMay 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT KNEE ARTHROPLASTY ON (B)(6) 2019, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 3 YEARS, 7 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19378043 ↗
• InjuryMar 14, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2020, APPROXIMATELY 4 YEARS, 6 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2020 - POSTOPERATIVE DIAGNOSIS: LOOSE LEFT TOTAL KNEE REPLACEMENT. THE POLYETHYLENE WAS REMOVED, THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE. IT¿S APPEARANCE LOOKED GOOD, HOWEVER, IT WAS NOTED TO BE LOOSE. THE PATIENT TOLERATED THE PROCEDURE WELL. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18904645 ↗
• InjuryNov 1, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST INITIAL LEFT TKA, THE 70 Y/O MALE PATIENT HAD A REVISION DUE TO POLY WEAR. PATIENT HAD A LINER WAS EXCHANGED. 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 DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 18052119 ↗
• InjurySep 16, 2022Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED THAT A 72 YO MALE PATIENT, WEIGHT: 102.7, WHO HAD A PRIMARY CR RTKA THROUGH A STANDARD TKA INCISION IMPLANTED ON (B)(6) 2015, PRESENTED TO THE SURGEON WITH PRIMARY COMPLAINTS OF SWELLING AND STIFFNESS. THE PATIENT WAS NEVER PLEASED WITH THE TKA FROM THE INITIAL SURGERY. AFTER DISSATISFACTION AND PAIN WITH THE KNEE, INFECTION AND INFLAMMATION TESTING WERE RUN ON THE PATIENT AND DID NOT SHOW A POSITIVE RESULT FOR INFECTION OR SIGNIFICANT INFLAMMATION. THE PATIENT WAS SCHEDULED FOR A REVISION RIGHT TKA POSSIBLE POLY SWAP FOR (B)(6) 2022, APPROXIMATELY 6 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON MADE AN INCISION OVER THE PREVIOUS TKA INCISION, OPENED THE KNEE JOINT, AND PERFORMED A SYNOVECTOMY. THE SURGEON THEN REMOVES THE ORIGINAL POLY IMPLANT. THE POLY IMPLANT SHOWED PITTING AND DELAMINATION ESPECIALLY MEDIALLY ON THE IMPLANT. THE SURGEON TESTED OR TOOK A TAMP TO THE METAL COMPONENTS TO CHECK IF THEY WERE WELL FIXED AND THEY WERE. THE SURGEON IRRIGATED THE KNEE WELL AND THEN BEGAN TRIALING. HE TRIALED WITH A 9MM CRC POLY AND FELT THAT THE IMPLANT TRIAL WAS STABLE. THE SURGEON REMOVED THE TRAIL, COMPLETED A SYNOVECTOMY, AND THEN RE-IMPLANTED A 9MM CRC POLY

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15438896 ↗
• InjuryJul 31, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND SYNOVITIS. MILD PITTING NOTICED. NEW 9MM CRC POLY IMPLANTED. NO OTHER KNOWN INFO.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 15136921 ↗

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