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Optetrak Logic 02-012-44-5017Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

All models of Optetrak Logic (408)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862248183), received between Jun 14, 2023 and Jun 14, 2023 — classified as 1 injury.

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

1 FDA recall record name this device's identifier, 1 still open.

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

Device problems

  • Naturally Worn1

Patient problems

  • Cyst(s)1
  • Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 14, 2023Naturally Worn; Naturally Worn

    AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REVISION (B)(6)2017. THEY HAD LEFT KNEE REVISION ON (B)(6)2023, APPROXIMATELY 5 YEARS 2 MONTHS AFTER THEIR INITIAL PROCEDURE. THERE WAS FOUND TO BE A LOOSE TIBIAL COMPONENT WITH A COMPLETELY LOOSE TIBIAL STEM. THERE WAS FOUND TO BE A MODERATE AMOUNT OF POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE. THERE WAS EVIDENCE OF POLYETHYLENE WEAR AND SYNOVIAL ENCAPSULATION. THERE WAS A HETEROTOPIC BONE FORMED AROUND THE PATELLA WITH A LOOSE PATELLAR COMPONENT. THE PATIENT ALSO HAD DEVELOPED A PRETIBIAL GANGLION CYST DUE TO THE LOOSE TIBIAL COMPONENT RUBBING UP AGAINST THE ANTERIOR CORTEX OF HIS MID LEFT TIBIA. 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: Cyst(s); Failure of Implant

    MAUDE report 17129033 ↗

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

All Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices →

Sources and updates

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