EMPHASYS 4840-07-100Recalls & reported problems
Depuy (Ireland) · EMPHASYS FEMORAL BROACH SIZE 7 · Class 2
All models of EMPHASYS (109)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295513759), received between Dec 16, 2022 and Apr 21, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility3
- Material Deformation1
- Material Integrity Problem1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT THE SIZE 7 BROACH IS DAMAGED & NECK TRIALS WILL NOT FIT ON IT. A REPLACEMENT NEEDS TO BE SEND. NO DELAY. NO COMPLICATIONS. ALL BROKEN PIECES RETRIEVED. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21874851 ↗MalfunctionApr 1, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING TRIALING OF FEMORAL COMPONENT, THE NECK TRIAL & BROACH WERE BENT, MAKING THEM UNUSABLE FOR TRIALING. THERE WERE NO COMPLICATIONS AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21739588 ↗MalfunctionDec 16, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE NIPPLE ATTACHMENT IS STRIPPED AND WON¿T LOCK WELL ON HANDLES. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15996707 ↗
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- ACTIS 3010-01-020Depuy (Ireland) · Instruments designed for press-fit osteochondral implants4 reports
- ACTIS 3010-01-030Depuy (Ireland) · Instruments designed for press-fit osteochondral implants4 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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