EMPHASYS 4722-52-436Recalls & reported problems
Depuy Orthopaedics, Inc. · EMPHASYS POLYETHYLENE LINER AOX +4 NEUTRAL 52MM 36MM · Class 2 · Implant
All models of EMPHASYS (34)
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 10603295501299), received between May 30, 2023 and May 7, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Dislocated4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Joint Dislocation4
- Fall1
- Joint Laxity1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT DISLOCATED FROM A FALL. ALL COMPONENTS WERE WELL FIXED . SURGEON REPLACED HEAD AND LINER. UPSIZING FROM FROM 36 MM TO 40 MM AND LENGTHENING FROM A +5 TO A +8.5. PATIENT LEFT SURGERY STABLE. AFFECTED SIDE-LEFT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 25111068 ↗InjuryDec 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT EXPERIENCED A DISLOCATED HIP DUE TO INSTABILITY. THE LINER AND HEAD WERE REPLACED TO REGAIN STABILITY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 23906209 ↗InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO ACUTE INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 20088311 ↗InjuryAug 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2023, (LEFT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.
Patient problems: Joint Dislocation
MAUDE report 17564223 ↗InjuryMay 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED INDICATES THE CONTINUATION OF DISLOCATION AND SUBLUXATION OF LEFT HIP HAS OCCURRED. NO TREATMENT WAS DOCUMENTED AS TREATMENT FOR THE DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 17021199 ↗
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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