EMPHASYS 4864-00-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295514015), received between Nov 15, 2023 and Apr 30, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 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 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MODULAR HANDLE AND STEM IMPACTOR BECAME STUCK TOGETHER AND WERE UNABLE TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25041635 ↗
• MalfunctionNov 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THEY KEEP GETTING STUCK TOGETHER, NO BROKEN PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140941 ↗