Optetrak Logic 02-010-03-0210Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862157973), received between Nov 20, 2020 and Nov 20, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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.

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.

• InjuryNov 20, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 YEARS AND 2 MONTHS AFTER THE INSERTION OF A LEFT FEMORAL COMPONENT USING HIGH VISCOSITY BONE CEMENT IN THE RIGHT KNEE OF AN OVERWEIGHT FEMALE PATIENT, THIS PATIENT PRESENTED TO ANOTHER SURGEON WITH PAIN IN HER KNEE. THE PATIENT WAS REVISED. PHOTOS OF THE REMOVED FEMORAL COMPONENT (REVIEWED BY THE INITIAL IMPLANTING SURGEON) WAS NOTED TO HAVE NO CEMENT ON IT. HE DID NOT SEE A PHOTO OF THE POLYETHYLENE. THIS SAME SURGEON STATED UPON REVIEW OF THE POST X-RAYS, IT IS HARD TO JUDGE AS TO L V. R DUE TO THIS SMALL SIZE COMPONENT. DEVICES WILL NOT BE RETURNED. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 10874732 ↗

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