EMPHASYS 4742-03-200Recalls & reported problems
Depuy (Ireland) · EMPHASYS 12/14 FEMORAL STEM COLLARED HIGH OFFSET HA COATED 3 HO · Class 2 · Implant
All models of EMPHASYS (109)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295505549), received between Nov 15, 2023 and Jan 8, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Osseointegration Problem1
Patient problems
- Limb Fracture2
- Inadequate Osseointegration1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FRACTURE AND STEM WAS LOOSE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Inadequate Osseointegration; Limb Fracture
MAUDE report 21105705 ↗InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE - FEMORAL. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT HIP). TREATMENT: NONE.
Patient problems: Limb Fracture
MAUDE report 18142218 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 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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