NA 4864-00-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295514039), received between Sep 4, 2025 and Apr 16, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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 16, 2026.

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.

• MalfunctionApr 16, 2026Material Deformation

  IT WAS REPORTED THAT DURING STEM EXTRACTION THE THREADS WERE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904024 ↗
• MalfunctionSep 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADED EMPHASYS EXTRACTION SHAFT WAS USED DURING THIS CASE TO EXPLANT A FEMORAL STEM, AND WORKED WELL. HOWEVER, WHEN REASSEMBLING THE TRAY TODAY THEY NOTICED A COUPLE OF THE THREADS WERE DAMAGED. IT APPEARS THE SURGEON MAY HAVE ACCIDENTALLY CROSS THREADED THE EXTRACTION SHAFT DURING THE EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961610 ↗