Optetrak Logic 02-012-49-1009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862174208), received between Jan 13, 2021 and Nov 1, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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.

• InjuryNov 1, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL LEFT TKA, THIS 71 Y/O FEMALE PATIENT WAS REVISED DUE TO WEAR OF THE TIBIAL INSERT. THE PATIENT WAS EXPERIENCING KNEE SWELLING AND PAIN. BREAKAGE AND WEAR WERE OBSERVED ON THE RETRIEVED TIBIAL INSERT. THE SURGEON DECIDED THAT THERE WAS NO PROBLEM FOUND ON THE LOCKING MECHANISM OF THE TIBIAL TRAY, AND AFTER REMOVING ALL PROLIFERATIVE TISSUES, ONLY THE INSERT WAS REPLACED. DEVICE IS NOT RETUNING, DEVICE IS GIVEN TO PATIENT.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 15708061 ↗
• InjuryJan 13, 2021Fracture; Fracture

  AS REPORTED, APPROXIMATELY THIRTY MONTHS POSTOP THE INITIAL RIGHT TKA, THE (B)(6) Y/O FEMALE PATIENT COMPLAINED KNEE SWELLING AND PAIN, THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT OF THE TIBIAL INSERT WAS PERFORMED. BREAKAGE AND WEAR WERE OBSERVED IN THE RETRIEVED TIBIAL INSERT. REMOVING ALL PROLIFERATIVE ISSUES, THE INSERT WAS REPLACED TO NEW ONE. THE SURGEON JUDGED THAT THERE IS NO PROBLEM WITH THE STABILITY OF THE TIBIAL TRAY AND THE LOCKING MECHANISM OF THE TIBIAL TRAY FOR TIBIAL INSERT FIXATION, THE INSERT WAS REPLACED TO 9MM THICKNESS OF SIZE 1 CR NEURAL TIBIAL INSERT.

  Patient problems: Failure of Implant

  MAUDE report 11163060 ↗

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