EMPHASYS 4813-00-000Recalls & reported problems
Depuy (Ireland) · EMPHASYS INCLINATION GUIDE STRAIGHT ACETABULAR IMPACTOR · Class 1
All models of EMPHASYS (109)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295514695), received between Oct 10, 2024 and Mar 20, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Break” (9 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
- Break9
- Device-Device Incompatibility2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Break
IT WAS REPORTED THAT THE PLASTIC VERSION ROD FOR EMPHASYS CUP IMPACTOR WAS BROKEN INTO TWO PIECES; BOTH PIECES RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651339 ↗MalfunctionJan 6, 2026Break; Crack; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED: "NOTICED AFTER CASE WAS FINISHED." SPLIT SHOWN IN PHOTO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23981849 ↗MalfunctionDec 24, 2025Break; Break
IT WAS REPORTED THAT THE EMPHASYS OFFSET INCLINATION GUIDE BROKEN INTO TWO PIECES. BOTH PIECES WERE RETRIEVED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888864 ↗MalfunctionDec 18, 2025Break; Break
IT WAS REPORTED THAT WHILE REMOVING THE ADAPTORS FROM THE EMPHASYS ALIGNMENT ROD, THE ROD BROKE AND CANNOT HOLD ONTO THE ADAPTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837865 ↗MalfunctionJun 30, 2025Break; Break
IT WAS REPORTED THAT SEVERAL DEVICES WERE STRIPPED AND ONE INSTRUMENT HAD A BROKEN CLIP PIECE BREAK OFF. THE EVENT DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22357050 ↗MalfunctionApr 21, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE WHEN SCRUB TECH PICKED IT UP WHILE OPENING TRAYS BEFORE THE PATIENT ENTERED THE ROOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21873883 ↗MalfunctionJan 7, 2025Break; Break
IT WAS REPORTED THAT THE INCLINATION GUIDE BROKE DURING THE CASE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21090334 ↗MalfunctionNov 12, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE VERSION GUIDE CONNECTION BROKE INTO 2 AND WILL NO LONGER FASTEN TO THE VERSION ADAPTOR. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20664250 ↗MalfunctionOct 10, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON (B)(6) 2024. DURING THE PROCEDURE, THE DOCTOR WAS TRYING TO REMOVE THE GUIDE AND SNAPPED IT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20416264 ↗
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- 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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