EMPHASYS 4710-60-300Recalls & reported problems
Depuy (Ireland) · EMPHASYS ACETABULAR SHELL THREE-HOLE 60MM 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295500643), received between Nov 4, 2024 and Jun 9, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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 Problem2
- Defective Device1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration1
- Joint Laxity1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Osseointegration Problem
IT WAS REPORTED THAT ASEPTIC LOOSENING HAD OCCURRED. AFFECTED SIDE-RIGHT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 25448565 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY OF THE HIP AND HAD TWO DISLOCATIONS. NO ALLEGATION AGAINST THE CUP. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 25427880 ↗MalfunctionApr 21, 2025Defective Device; Defective Device
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, THE SURGEON FELT THAT GRIPTION S COATING ON THE EMPHASYS ACETABULAR SHELL WAS NOT ADEQUATE. SURGERY WAS DELAYED BY TWO MINUTES. THE SURGEON SWITCHED TO PINNACLE MULTI HOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21873844 ↗InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS STILL SHOWING SIGNS OF INFECTION SO THE DOCTOR PERFORMED A FIRST STAGE REVISION BY REMOVING EVERYTHING, WASHING IT OUT EXTENSIVELY, AND PUTTING NEW IMPLANTS IN. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 20600958 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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