EMPHASYS 4710-56-900Recalls & reported problems
Depuy (Ireland) · EMPHASYS ACETABULAR SHELL MULTI-HOLE 56MM CEMENTLESS · Class 2 · Implant
All models of EMPHASYS (109)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295502975), received between Mar 5, 2026 and Sep 16, 2026 — classified as 5 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
- Use of Device Problem1
Patient problems
- Unspecified Infection2
- Inadequate Osseointegration1
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Use of Device Problem
It was reported that Pt had a revision cup put in because the original was mispositioned in his primary surgery. There were no broken instruments, nor any complaints made about our products/instrumentation.DOI-(b)(6) 2026,DOR-(b)(6) 2026,Affected side-Left.
Patient problems: Insufficient Information
MAUDE report 50791691 ↗InjuryJun 1, 2026Osseointegration Problem
IT WAS REPORTED THAT DUE TO CUP LOOSENING, THE DOCTOR REMOVED CUP AND REPLACED WITH COMPETITOR CUSTOM TRI FLANGE CUP. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 25355539 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION, EXPLANTED ALL COMPONENTS FOR I AND D. THERE WAS NO DELAY IN THE CASE, THERE WAS NO HARM DONE TO THE PATIENT, THERE WERE NO COMPLAINTS. I HAD NO FURTHER INFORMATION LAST REVISION WAS (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24530847 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION, EXPLANTED ALL COMPONENTS FOR I AND D. THERE WAS NO DELAY IN THE CASE, THERE WAS NO HARM DONE TO THE PATIENT, THERE WERE NO COMPLAINTS. I HAD NO FURTHER INFORMATION LAST REVISION WAS (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24530793 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THEY HAD TO EXPLANT ALL IMPLANTS BECAUSE PATIENT WAS UNSTABLE DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 24518080 ↗
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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