Optetrak Logic 02-012-47-2013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862174260), received between Sep 15, 2022 and Jul 13, 2023 — 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.

• InjuryJul 13, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2018. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 7 YEARS 2 MONTHS AFTER THEIR INITIAL IMPLANTATION. ON (B)(6) 2022 OP REPORT NOTED SIGNIFICANT SEROUS FLUID IDENTIFIED IN THE KNEE AND SIGNIFICANT SYNOVIAL HYPERTROPHY AND INFLAMMATION. THE POLYETHYLENE HAD SIGNIFICANT EROSION AND DELAMINATION AFFECTING THE MEDIAL AND THE POSTERIOR QUARTER OF THE POLYETHYLENE LINER. ALL COMPONENTS WERE SOLIDLY FIXED. THERE WAS MINIMAL EROSION MEDIALLY ON THE TIBIAL TRAY BUT WAS EXTREMELY STABLE. THE PATIENT TOLERATED THE PROCEDURE QUITE NICELY. 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: Insufficient Information; Synovitis

  MAUDE report 17321038 ↗
• InjurySep 15, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2019. THE PATIENT WAS REVISED DUE TO WEAR IN THE LINER/TIBIAL COMPONENTS. THE TIBIA, LINER AND PATELLA WERE REVISED TO EXACTECH PRODUCTS. THERE WAS NO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain

  MAUDE report 15426451 ↗

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