EMPHASYS 4840-05-100Recalls & reported problems
Depuy (Ireland) · EMPHASYS FEMORAL BROACH SIZE 5 · Class 2
All models of EMPHASYS (109)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295513735), received between Dec 7, 2022 and Dec 7, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (1 report).
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.
Most reported problems
Device problems
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 7, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT THE SURGEON STATED THE TOLERANCE ON PLANAR SHAFT IS TOO TIGHT ON BROACH TRUNNION CAUSING DAMAGE TO BROACH. BROACH HAS VISIBLE WEAR ON TRUNNION. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15932016 ↗
Other Instruments designed for press-fit osteochondral implants devices
- ACTIS 3010-01-060Depuy (Ireland) · Instruments designed for press-fit osteochondral implants14 reports
- ACTIS 3010-01-050Depuy (Ireland) · Instruments designed for press-fit osteochondral implants14 reports
- ACTIS 3010-01-040Depuy (Ireland) · Instruments designed for press-fit osteochondral implants12 reports
- ACTIS 3010-01-070Depuy (Ireland) · Instruments designed for press-fit osteochondral implants12 reports
- ACTIS 3010-01-080Depuy (Ireland) · Instruments designed for press-fit osteochondral implants7 reports
- ACTIS 3010-01-010Depuy (Ireland) · Instruments designed for press-fit osteochondral implants5 reports
- 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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