EMPHASYS 4810-50-900Recalls & reported problems
Depuy (Ireland) · EMPHASYS TRIAL SHELL 50mm · Class 1
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 10603295503965), received between Mar 4, 2026 and Apr 13, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
- 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.
MalfunctionApr 13, 2026Material Deformation
IT WAS REPORTED THAT THE TRIAL BECAME CROSS THREADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859610 ↗MalfunctionMar 4, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT SOMETHING WAS WRONG WITH THE THREADS, ON THE FIRST USE EVER A CUP TRIAL GOT STUCK AND WILL NOT COME OFF. THEY NEED THE HANDLE, 50 CUP TRIAL, AND SCREWDRIVER. THE THREADS WOULD NOT LET GO OF THE CUP NO MATTER HOW HARD ANYONE TRIED TO UNTHREADED IT. THEY ARE POSSIBLY CROSS THREADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24511475 ↗
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- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- 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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