EMPHASYS 4722-56-440Recalls & reported problems
Depuy Orthopaedics, Inc. · EMPHASYS POLYETHYLENE LINER AOX +4 NEUTRAL 56-58MM 40MM · Class 2 · Implant
All models of EMPHASYS (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295500117), received between Jun 20, 2025 and Sep 18, 2026 — classified as 7 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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
- Adverse Event Without Identified Device or Use Problem5
- Device Dislodged or Dislocated2
- Material Deformation1
Patient problems
- Unspecified Infection3
- Joint Dislocation2
- Joint Laxity2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50829009 ↗InjurySep 18, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50827230 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT I&D HEAD AND LINER WERE EXCHANGE. AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 24884423 ↗InjuryMar 9, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S HIP DISLOCATED AT HOME. DOCTOR TRIED TO DO A CLOSED REDUCTION UNDER X-RAY, BUT HIP CONTINUED TO DISLOCATE WITH MINIMAL LEG MANIPULATION. DOCTOR REMOVED ACETABULAR COMPONENTS AND REPLACED WITH DUAL MOBILITY FOR MORE STABILITY. DOI: (B)(6) 2025, DOR: (B)(6) 2026 , AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 24551646 ↗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 24518058 ↗InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION OF HIP. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22743335 ↗MalfunctionJun 20, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE THREADS OF THE INSTRUMENT WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22299131 ↗InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INFECTED THA. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 22298986 ↗
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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