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EMPHASYS 4840-03-100Recalls & reported problems

Depuy (Ireland) · EMPHASYS FEMORAL BROACH SIZE 3 · Class 2

All models of EMPHASYS (109)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295513711), received between Dec 1, 2022 and Jan 19, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Device problems

  • Break1
  • Device-Device Incompatibility1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT BROACH WAS NOT COME OFF INSERTION HANDLE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16208988 ↗
  • MalfunctionDec 1, 2022Break; Break

    IT WAS REPORTED THAT SIZE 3 EMPHASYS BROACH ATTACHMENT BROKE. THERE WAS NO REPORTED SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15894515 ↗

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Sources and updates

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