Optetrak Logic 02-013-35-3513Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862004314), received between Aug 15, 2022 and Aug 15, 2022 — classified as 1 injury.

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

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.

Most reported problems

Recent adverse event reports

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

• InjuryAug 15, 2022Break; Break

  IT WAS REPORTED THAT DURING THIS 57 Y/O FEMALE PATIENT'S RIGHT KNEE REVISION, THE LOGIC STYLE POLY TRIAL WHEN TRYING TO INSERT IT INTO THE KNEE WITH THE CEMENTED IMPLANTS BROKE OR SNAPPED INTO TWO PIECES. WHILE THE SURGEON REMOVED THE 9MM PS POLY THAT WAS IN THE PATIENT FROM THE ORIGINAL SURGERY AND BEGAN TRIALING THICKER OPTIONS OF THE POLY. THE SURGEON USED THE LOGIC STYLE 3.5MM - 13MM POLY TO TRIAL AND UPON INSERTING THE POLY TRAIL, THE PLASTIC BROKE OR SNAPPED INTO TWO PIECES. THE SURGEON NEEDED TO USE STRENGTH TO BE ABLE TO INSERT THE POLY FOR TRIALING. THE SURGERY WAS DELAYED WITH HAVING TO REMOVE THE PIECES OF THE TRAIL, IRRIGATE THE KNEE SITE AND START RE-TRIALING WITH THE TRULIANT STYLE OF POLYS. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PATIENT LEFT THE OR STABLE. THE BROKEN IMPLANT WAS ISOLATED, CLEANED, AND IS BEING SENT BACK TO EXACTECH AND REPLACED. REVISION STATED IN THE SUMMARY IS CAPTURED IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15228408 ↗