EMPHASYS 4822-56-436Recalls & reported problems
Depuy (Ireland) · EMPHASYS TRIAL LINER +4 NEUTRAL 56-58OD x 36ID · 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 10603295510796), received between May 15, 2025 and Mar 30, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Unintended Movement1
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.
MalfunctionMar 30, 2026Break
IT WAS REPORTED THAT THE EMPHASYS TRIAL LINER WAS BROKEN. THE EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716054 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT EMSYS TRL LNR +4N 56-58X36 LINER TRIAL BROKE WHILE SCREWING INTO THE CUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494969 ↗MalfunctionFeb 10, 2026Unintended Movement
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE, THE RETAINING SCREW WAS LOOSE. NO PATIENT WAS HARMED AND CASE WAS NOT EXTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24303606 ↗MalfunctionMay 15, 2025Break; Break
IT WAS REPORTED THAT LINER TRIAL BROKE WHILE REMOVING FROM CUP. ALL PIECES BEING RETURNED.
Patient problems: Insufficient Information
MAUDE report 22027809 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- 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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