EMPHASYS 4819-22-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295528340), received between Dec 17, 2025 and Sep 15, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  It was reported that during a primary hip surgery the supervising ortho consultant was using a press to disassemble the dual mobility system. They used the piece intended for a 22.2/28mm head trial extraction to remove a 36mm head instead of the 36mm adaptor. During this process one of the small tabs that aligned with the grooves of the liner trial snapped off the construct. No patient or user harm was reported. There was no significant delay. No parts remained in situ of the of patient. The part broke over the working trolley. The small piece of plastic that broke off the instrument was disposed of by the surgeon at the time. The remainder of the part remained with SSD Hospital. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774984 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT DURING DECONTAMINATION AFTER SURGERY, IT WAS NOTICED THAT A PIECE HAD BROKE OFF OF THE TRIAL HEAD REMOVAL TOOL. THE DEVICE WAS NOT USED DURING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216362 ↗
• MalfunctionApr 13, 2026Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT WHEN USING THE INSTRUMENT ,IT WAS DROPPED ON THE FLOOR AND ONE OF THE FINS OF THE HEAD EXTRACTOR BROKE OFF. ENDED UP DESTROYING THE HEAD TRIAL IN THE PROCESS OF TRYING TO CHANGE HEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24861202 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT THE BROKEN TONGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831826 ↗