ARTICUL/EZE 1365-22-000Recalls & reported problems
Depuy (Ireland) · ARTICUL/EZE FEMORAL HEAD Diameter 32mm +5 12/14 TAPER · Class 2 · Implant
All models of ARTICUL/EZE (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ARTICUL/EZE femoral head is the ball component of a hip replacement. Its 218 reports mostly describe the hip dislocating, and many describe patients needing revision surgery for pain, dislocation or infection. The reports include 216 injuries and no deaths. Reports fell from 13 in the prior 12 months to 5 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 220
- Deaths reported
- 0
- Injuries reported
- 218
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 10603295033189), received between Jun 30, 2017 and Sep 18, 2026 — classified as 218 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (108 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated108
- Adverse Event Without Identified Device or Use Problem91
- Insufficient Device Problem Information12
- Appropriate Device Problem Term/Code Not Available6
- Noise, Audible4
- Naturally Worn3
- Biocompatibility1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Joint Dislocation109
- No Code Available64
- Pain51
- Unspecified Infection41
- Test Result14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Joint Laxity10
- Foreign Body Reaction9
Recent adverse event reports
The 25 most recent of 220 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Device Dislodged or Dislocated
It was reported that recurrent left hip dislocations.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected Side: Unknown.
Patient problems: Joint Dislocation
MAUDE report 50817295 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient needed revision due to instability.DOI: (b)(6) 2019.DOR: (b)(6) 2026.Affected side: Left hip.
Patient problems: Joint Laxity
MAUDE report 50061396 ↗InjuryMar 31, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT EXPERIENCED A CHRONIC DISLOCATION OF OPERATIVE HIP. PATIENT UNDERWENT AN ACETABULUM REVISION. DOI: ON (B)(6) 2020, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 24745051 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO GROIN PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 24559715 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTED CONSTRAINED LINER FOR STABILITY. DOI: UNKNOWN , DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Laxity
MAUDE report 24193227 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24040314 ↗InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 23833387 ↗InjuryOct 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 23402439 ↗InjuryAug 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT RETURNED TO SURGERY AFTER SEVERAL DISLOCATIONS. THE CUP WAS REVISED TOO. AFFECTED SIDE: LEFT SIDE.
Patient problems: Joint Dislocation
MAUDE report 22849359 ↗InjuryJul 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN IN OPERATIVE SIDE HIP, AND SURGEON FOUND THAT PATIENT WAS CHRONICALLY DISLOCATING. DURING REVISION SURGERY IT WAS DETERMINED THAT LINER HAD EXCESSIVE WEAR WHICH ALLOWED THE DISLOCATIONS TO OCCUR. HEAD WAS REMOVED FROM STEM AND CUP LINER WAS EXCHANGED. OLD LINER AND NEW LINER ARE BOTH COMPETITOR PRODUCTS. NOTHING FOUND WRONG OR DEFECTIVE WITH OUR HEAD. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation; Pain
MAUDE report 22636750 ↗InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22518614 ↗InjuryJul 3, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL SURGERY ON AN UNKNOWN DATE TO HAVE A HIP JOINT INSTALLED. AFTER AWHILE, PATIENT WAS ADMITTED TO THE HOSPITAL WITH A HIP DISLOCATION IN AN EXTREME POSITION. DURING REVISION SURGERY, IT WAS REVEALED THAT THE INSERT AND THE HEAD WERE IDENTICALLY ERASED. IMPLANT WAS REMOVED.
Patient problems: Joint Dislocation
MAUDE report 22395178 ↗InjuryMay 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT 'S HUSBAND FELL ON HER AND DISLOCATED THE HIP. REVISION WAS PERFORMED. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 22013041 ↗MalfunctionMay 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAD A SUMMIT POROUS STEM WITH AN ARTICULEZE FEMORAL HEAD IMPLANTED ALONG WITH A ZIMMER CUP. PATIENT DISLOCATED AND SURGEON REVISED THE HIP BECAUSE OF THAT. DOI: UNKNOWN. DOR: (B)(6) 2025; AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21961835 ↗InjuryMay 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE LEFT HIP WAS REVISED BECAUSE IT DISLOCATED TWICE BEFORE. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 21942498 ↗InjuryApr 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. HEAD AND LINER WERE REVISED TO A LONGER HEAD AND A 36 LINER. A 32 LIPPED LINER AND A 32 HEAD WERE REMOVED. PRODUCTS INFO WAS UNAVAILABLE. DOI: (B)(6) 3035. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21936738 ↗InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT CUP REVISED DUE TO INSTABILITY. DOI: (B)(6) 2016. DOR: (B)(6) 2025 AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 21699867 ↗InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN OF HIP. THERE WAS NO SURGICAL DELAY AND THERE WERE NO ADVERSE EFFECTS. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Pain
MAUDE report 21316138 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD HEAD SWAP FOR INFECTED HIP. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 20845022 ↗InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT HIP REVISION SURGERY. THE PATIENT EXPERIENCED PAIN AS A RESULT OF THE INSERT SLIPPING OUT OF THE BEARING SHELL. AFTER THE PATIENT WAS OPENED DURING THE PROCEDURE, ADVANCED METALOSIS WAS PRESENT IN THE JOINT. THE OPERATION ENDED WITH A REVISION. THE BEARING SHELLS, THE INSERTS AND THE REPLACEMENT OF THE HEAD ON THE FEMUR STEM. ELEMENTS WERE REMOVED FROM THE PATIENT'S BODY AND INTRAOPERATIVE IMAGES WERE TAKEN. THE SWAB WAS TAKEN FOR LABORATORY EXAMINATION.
Patient problems: Foreign Body Reaction; Pain
MAUDE report 20770810 ↗InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE SO THE DOCTOR SENT AND SWAPPED THE HEAD AND THE POLY FOR A DUAL MOBILITY CONSTRUCT. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2009, DOR: (B)(6) 2024 , AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 20004495 ↗InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE STEM AND LINER WERE REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 19981117 ↗InjuryJul 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2017, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 19760923 ↗InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP SIDE.
Patient problems: Pain
MAUDE report 19721723 ↗InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? -NO. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? -NO.
Patient problems: Pain
MAUDE report 19711225 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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