ARTICUL/EZE 1365-13-000Recalls & reported problems
Depuy (Ireland) · ARTICUL/EZE FEMORAL HEAD Diameter 28mm +8.5 12/14 TAPER · Class 2 · Implant
Quick summary
This DePuy ARTICUL/EZE femoral head has 145 FDA adverse event reports, including 1 death and 140 injuries. Many describe hip dislocations, and some mention infections or pain that led to revision surgery. Some also mention parts coming loose. 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
- 147
- Deaths reported
- 1
- Injuries reported
- 142
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 10603295033103), received between Jan 9, 2017 and Sep 10, 2026 — classified as 1 death, 142 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (55 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem72
- Device Dislodged or Dislocated55
- Insufficient Device Problem Information7
- Naturally Worn6
- Appropriate Device Problem Term/Code Not Available5
- Difficult to Insert3
- Disconnection2
- Fracture2
Patient problems
- Joint Dislocation54
- No Code Available40
- Unspecified Infection37
- Pain30
- Joint Laxity8
- Not Applicable7
- Foreign Body Reaction5
- Injury4
Recent adverse event reports
The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Device Dislodged or Dislocated
It was reported that patient had dislocation.DOI: (b)(6)2026..DOR:(b)(6)2026.Affected side: Left Hip.
Patient problems: Joint Dislocation
MAUDE report 50718005 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had infection and needed to have everything removed to place an antibiotic spacer.DOI- (b)(6) 2026.DOR- (b)(6) 2026.Affected side-Right hip.
Patient problems: Unspecified Infection
MAUDE report 50093431 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 24859889 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD AN INFECTED HIP IN WHICH MULTIPLE WASHOUTS DID NOT CLEAR THE INFECTION. SURGEON REMOVED IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 24768932 ↗InjuryFeb 20, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS DISLOCATING AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24399977 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN.
Patient problems: Pain
MAUDE report 24187040 ↗InjuryJan 15, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISLOCATION AND SUBSEQUENTLY UNDERWENT A PROCEDURE INVOLVING THE PLACEMENT OF A NEW CONSTRAINED LINER AND HEADBALL. NO ADDITIONAL INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 24081329 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS INFECTED AND DOCTOR PERFORMED I&D AND CHANGED BIPOLAR HEAD. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 23864847 ↗InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT BIPOLAR REMOVED BECAUSE OF INFECTION. AFFECTED SIDE-LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 23716369 ↗InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. SURGEON PERFORMED A WASHOUT AND HEAD SWAP. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 23622616 ↗InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT FELL AND HAD OPENED INCISION. I&D HEAD AND BIPOLAR WERE EXCHANGED. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Wound Dehiscence
MAUDE report 23337450 ↗MalfunctionSep 16, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE BI-POLAR HEAD IMPLANT DID NOT WORK PROPERLY. AFFECTED SITE - RIGHT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23065043 ↗InjurySep 11, 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 23030729 ↗InjuryJul 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PC REPORTED BEFORE FOR MULTIPLE DISLOCATION? YES. B. WAS THERE ANY ALLEGATION ON THE REPORTED PRODUCTS OTHER THAN THE HEAD AND LINER? NO.
Patient problems: Joint Dislocation
MAUDE report 22541491 ↗InjuryJul 10, 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 DISLOCATION AND FEAR OF INFECTION. DOCTOR OPTED TO GO UP IN SIZE FOR THE BIPOLAR COMPONENT AND THE HEADBALL. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22470300 ↗InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ACTIS STEM, BIPOLAR HEAD AND ARTICUL/EZE HEAD WERE REMOVED BECAUSE OF INFECTION. ALL IMPLANTS WERE REMOVED WITHOUT ANY ISSUES. THERE WAS NO DELAY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22420860 ↗InjuryMay 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT CAME BACK IN WITH A DISLOCATED BIPOLAR CONSTRUCT. THE HEAD WAS ATTACHED TO THE STEM BUT THE BIPOLAR WAS DISASSOCIATED FROM THE HEAD. THE SURGEON REMOVED THE BIPOLAR AND HEAD. HE RE-IMPLANTED A 44 BIPOLAR AND 28 +12 HEAD. UNKNOWN SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 22026126 ↗InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED THAT THE PATIENT IS BEING REVISED FOR ELEVATED METAL ION LEVELS FROM METAL ON METAL HIP REPLACEMENT. PATIENT WAS CONVERTED TO A PINNACLE DM CONSTRUCT. DOI: (B)(6) 2004. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Metal Related Pathology
MAUDE report 21422012 ↗InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS A LEFT HEMI HIP THAT IS INFECTED. THE SURGEON DID A WASHOUT AND HEAD EXCHANGE. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 21324438 ↗InjuryJan 3, 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) 2024. AFFECTED SIDE: LEFT KNEE.
Patient problems: Pain
MAUDE report 21069678 ↗InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED FOR PAINFUL BIPOLAR COMPONENT. THE STEM WAS FOUND TO BE LOOSE AND WAS REVISED TOO. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 20693458 ↗InjuryNov 12, 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. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 20663424 ↗InjuryOct 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HIP WAS DISLOCATING, PRIMARY SURGERY WAS 22 YEARS AGO. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 20431723 ↗InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO HIP WAS INFECTED. SURGEON DID AN IRRIGATION AND DEBRIDEMENT AND A HEAD EXCHANGE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 20408029 ↗InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. NO LOOSENING WAS THERE. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 19761225 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.