EMPHASYS 4822-48-036Recalls & reported problems
Depuy (Ireland) · EMPHASYS TRIAL LINER NEUTRAL 48OD x 36ID · Class 1
All models of EMPHASYS (109)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295510550), received between Sep 13, 2024 and Sep 25, 2026 — classified as 5 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
- Crack2
- Device-Device Incompatibility1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Break; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903436 ↗MalfunctionApr 13, 2026Crack
IT WAS REPORTED THAT TRIAL LINER CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860590 ↗MalfunctionJul 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE EMPHASYS 48/36 LINER IS WORN WON'T PROPERLY THREAD. THIS DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22470243 ↗MalfunctionMar 31, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE 35/48 N EMPHASYS TRIAL LINER CRACKED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21734064 ↗MalfunctionSep 13, 2024Break; Break
IT WAS REPORTED THAT UPON INSPECTION THE FOLLOWING PARTS WERE FOUND. EMPHASYS TRL LNR N 48X36: CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20213137 ↗
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- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
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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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