Optetrak Logic 02-012-47-3515Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862159274), received between Sep 2, 2022 and May 14, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 118 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, STIFFNESS, OSTEOLYSIS AROUND THE PROXIMAL TIBIA, SYNOVITIS, ABNORMAL WEAR OF THE TIBIAL INSERT ON THE MEDIAL SIDE AND OXIDATION OF THE LATERAL SIDE, AND DELAMINATION OF THE PATELLA. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 19315357 ↗
• InjurySep 2, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 72 YO MALE PATIENT, INITIAL EXACTECH CR LEFT TKA, IMPLANT DATE OF (B)(6) 2016, PRESENTED WITH PAIN, DECREASED SATISFACTION, AND HE STEPPED DOWN ON HIS KNEE AND FELT MORE PAIN, AND STIFFNESS. A CT SHOWED OSTEOLYSIS, BONE RESORPTION, AND A SLIGHT FX THROUGH THE FEMUR AT THAT TIME. CULTURES AND INFECTION TESTING WERE DONE ON THE PATIENT WITH NEGATIVE RESULTS PRIOR TO THE REVISION SX. THE POLY IMPLANT THAT WAS IN THE PATIENT FROM THE ORIGINAL SX WAS SEARCHED WITHIN THE RECALL DATABASE AND DID COME BACK AS AN AFFECTED RECALLED IMPLANT. THE PATIENT UNDERWENT REVISION SURGERY, APPROXIMATELY 6 YEARS 6 MONTHS POST THE INITIAL IMPLANT PROCEDURE, AND THE SURGEON REMOVED THE IMPLANTED AFFECTED POLY. THE POLY APPEARED TO HAVE SOME CRATERING/PITTING AND DELAMINATION ON THE ARTICULAR SURFACE. THE SURGEON TESTED THE METAL COMPONENTS TO MAKE SURE THAT THEY WERE WELL FIXED AND NOT LOOSE. THE FEMUR AND TIBIA WERE WELL FIXED. THE SURGEON TRIALED WITH CRC TRIALS AND DECIDED TO RE-IMPLANT A 15MM CRC ANTERIOR STABILIZED POLY. THE KNEE WAS STABLE, AND THE PATIENT WAS STABLE LEAVING THE OPERATING ROOM.

  Patient problems: Bone Fracture(s); Osteolysis; Pain

  MAUDE report 15347483 ↗

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