EMPHASYS 4710-46-300Recalls & reported problems
Depuy (Ireland) · EMPHASYS ACETABULAR SHELL THREE-HOLE 46MM CEMENTLESS · Class 2 · Implant
All models of EMPHASYS (109)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295500575), received between Apr 17, 2025 and Apr 13, 2026 — classified as 4 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 Problem3
- Osseointegration Problem1
Patient problems
- Bone Fracture(s)1
- Inadequate Osseointegration1
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT WAS REVISED DUE TO UNSTABLE HIP. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6), 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 24862798 ↗InjuryApr 9, 2026Osseointegration Problem
PATIENT WAS REVISED DUE TO LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. EMPHASYS CUP DID NOT GROW IN, REMOVED CUP/LINER AND HEAD BALL. DOI: (B)(6) 2024. DOR:(B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 24831653 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD SINGLE STAGE REVISION. AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24790739 ↗InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FRACTURED PELVIS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: UNKNOWN.
Patient problems: Bone Fracture(s)
MAUDE report 21858418 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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