EMPHASYS 4722-44-032Recalls & reported problems
Depuy (Ireland) · EMPHASYS POLYETHYLENE LINER AOX NEUTRAL 44MM 32MM · 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 10603295500988), received between Nov 28, 2023 and Apr 9, 2026 — classified as 2 injuries.
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
- Device Dislodged or Dislocated2
Patient problems
- Joint Dislocation2
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP PLACED ON THE ABOVE LISTED DATE FOR CROWE 4 HIP DYSPLASIA. UNFORTUNATELY, PATIENT DISLOCATED HIP ON POST OP DAY 1 AND WAS BROUGHT BACK TO THE OR FOR A HIP REVISION. SURGEON BELIEVES THAT THE CHOSEN ANTEVERSION THAT WAS SELECTED AT THE INDEX PROCEDURE WAS TOO GREAT AND THE FEMORAL COMPONENT WAS REVISED ACCORDINGLY. ONCE PLACED, SURGEON WAS STILL CONCERNED WITH HOW QUICKLY PATIENT HAD DISLOCATED POSTOPERATIVELY AND CHOSE TO ALSO CHANGE THE LINER TO AN ELEVATED RIM LINER TO FURTHER ENHANCE STABILITY. A FRACTURE OF THE GREATER TROCHANTER OCCURRED DURING THE INDEX PROCEDURE AND WAS TREATED WITH A TROCHANTERIC PLATE, INCLUDING CABLES AND A SCREW FOR STABILIZATION. NO DELAY AND NO PATIENT HARM WAS NOTED. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 24831512 ↗InjuryNov 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO UNIQUE ANATOMY AND THE HIP DISLOCATED. THIS NEUTRAL LINER WAS REPLACED WITH AN ELEVATED RIM LINER. DOI: (B)(6) 2023. DOR: NOVEMBER 10, 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 18216072 ↗
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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