EMPHASYS 4813-00-550Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295545460), received between May 15, 2025 and Aug 17, 2026 — classified as 3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278049 ↗
• MalfunctionMar 20, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING THE REAL CUP IMPLANTATION, THE INCLINATION GUIDE ADAPTOR WAS ATTACHED TO THE IMPACTOR TO CHECK THE ALIGNMENT OF THE IMPACTOR. AFTER CONFIRMING ALIGNMENT, THE INCLINATION GUIDE ADAPTOR COULD NOT BE DETACHED. THE SURGEON USED KOCHER FORCEPS TO REMOVE THE ADAPTOR, BUT IT WAS UNSUCCESSFUL. IMPACTING USING A HAMMER WAS PERFORMED WHILE THE ADAPTOR WAS STILL ATTACHED, AND THE VIBRATION FROM THE IMPACTING CAUSED THE ADAPTER TO FALL OFF, AND THE ADAPTOR BECAME UNCLEAN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647875 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT THE EMPHASYS ADAPTOR IS BROKEN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027338 ↗