EMPHASYS 4851-05-100Recalls & reported problems
Depuy (Ireland) · EMPHASYS TRIAL NECK STANDARD OFFSET SIZE 5-6 · Class 1
All models of EMPHASYS (109)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10603295513834), received between Mar 22, 2023 and Sep 15, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
Device problems
- Device-Device Incompatibility4
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE BROACH AND TRIAL NECK WERE VERY HARD TO DISASSOCIATE. THE NECK AND BROACH APPEAR HAVE SOME BURRING ON THEM. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17754825 ↗MalfunctionMar 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON HAD STATED HEAD AND NECK TOLERANCES ARE TOO TIGHT WITH EMPHASYS. THERE WAS A SURGICAL DELAY OF 5 MINUTES.
Patient problems: Insufficient Information
MAUDE report 16610274 ↗MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON STATES TOLERANCES BETWEEN HEAD AND NECKS OF EMPHASYS WERE TOO TIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16594054 ↗MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON STATES TOLERANCES ON ALL EMPHASYS TRIAL NECKS AND HEADS ARE TOO TIGHT. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16592274 ↗
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- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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