Optetrak Logic 02-012-47-2511Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862159151), received between Aug 3, 2023 and Jul 11, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 64 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THERE WAS NO REPORTED SURGICAL DELAY OR DEVICE BREAKAGE. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19720630 ↗
• InjurySep 27, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 76 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 2 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT UNDERWENT A POLY TIBIAL INSERT SWAP AND PATELLA IMPLANT SWAP AND WAS REIMPLANTED WITH A TRULIANT CRC TIBIAL INSERT CRC SIZE 2.5, 13MM SN: (B)(6) AND AN OPTETRAK 3 PEG PATELLA CEMENTED 29MM SN: (B)(6). 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 DEVICE RETURNS ANTICIPATED FOR ANALYSIS. THE IMPLANT(S) WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. NO FURTHER INFORMATION.

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

  MAUDE report 17830270 ↗
• InjuryAug 3, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2013. THEY UNDERWENT RIGHT KNEE REVISION SURGERY (B)(6) 2023, APPROXIMATELY 9 YEARS 8 MONTHS POST PRIMARY PROCEDURE. (B)(6) 2023, OP REPORT SURGICAL FINDINGS: SIGNIFICANT SYNOVIAL FLUID WITH HYPERTROPHIC SYNOVIAL TISSUE AND GRANULOMATOUS SYNOVIUM LARGE AMOUNT AWARE OF THE MEDIAL TIBIAL INSERT AND MILD PATELLA POLYETHYLENE WEAR. POLYETHYLENE INSERT WAS NOTED TO HAVE SIGNIFICANT WEAR OF THE MEDIAL PLATEAU. NONE OF THE IMPLANTS SHOWED EVIDENCE OF SEVERE BONE LOSS OR LOOSENING. THE PATIENT TOLERATED THE PROCEDURE WELL WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. 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; Failure of Implant; Swelling/ Edema

  MAUDE report 17451514 ↗

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