EMPHASYS 4864-00-020Recalls & reported problems
Depuy (Ireland) · EMPHASYS STEM IMPACTOR SHAFT OFFSET · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295514022), received between Feb 6, 2023 and Nov 16, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Device-Device Incompatibility2
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2023Break; Break
IT WAS REPORTED THAT BOTH INSERTER AND HEAD IMPACTORS ARE CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18156101 ↗MalfunctionNov 16, 2023Break; Break
IT WAS REPORTED THAT BOTH INSERTER AND HEAD IMPACTORS ARE CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18156098 ↗MalfunctionFeb 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE OFFSET STEM AND CURVED CANAL PROB WILL NOT CONNECT TO THE HANDLE WITHOUT BECOMING STUCK. DELAYS SURGERY HAVING TO DISCONNECT THEM. THERE WAS A SURGICAL DELAY OF 5 MINUTES.
Patient problems: Insufficient Information
MAUDE report 16303298 ↗MalfunctionFeb 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE OFFSET STEM AND CURVED CANAL PROB WILL NOT CONNECT TO THE HANDLE WITHOUT BECOMING STUCK. DELAYS SURGERY HAVING TO DISCONNECT THEM. THERE WAS A SURGICAL DELAY OF 5 MINUTES.
Patient problems: Insufficient Information
MAUDE report 16303273 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.