3DMetal Tibial Cones 02.07.CXS25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030884061), received between Mar 4, 2026 and Mar 4, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Incompatible” (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.

• MalfunctionMar 4, 2026Component Incompatible; Difficult or Delayed Positioning

  DURING THE FINAL IMPLANT POSITIONING, A DISCREPANCY WAS NOTED COMPARED TO WHAT HAD BEEN OBSERVED DURING TRIALING. THE FINAL IMPLANT RESULTED FEW MILLIMETERS HIGHER THAN THE TIBIAL CUT. THE SURGEON HAD TO REMOVE THE IMPLANTED CONE, ALREADY CEMENTED. AFTER ADDITIONAL BONE REAMING AND NEW CEMENTATION, A SMALLER CONE WAS IMPLANTED (THE SIZE WAS CHANGED FROM 25 MM TO 20 MM). THIS RESULTED IN 1 HOUR-DELAY, TOTAL SURGERY TIME 3 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504540 ↗