ARTICUL/EZE 4734-36-920Recalls & reported problems
Depuy Orthopaedics, Inc. · ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 36mm minus 2 · Class 2 · Implant
All models of ARTICUL/EZE (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295505693), received between Jun 5, 2024 and Sep 23, 2026 — classified as 21 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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
- Adverse Event Without Identified Device or Use Problem14
- Device Dislodged or Dislocated7
- Fracture5
Patient problems
- Unspecified Infection11
- Joint Dislocation7
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information2
- Pain2
- Fall1
- Fluid Discharge1
- Joint Laxity1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revised due to Infection.Affected Side: Right Hip.
Patient problems: Unspecified Infection
MAUDE report 50870169 ↗MalfunctionSep 22, 2026Fracture
It was reported that the ball was placed on the trunnion, then impacted by a Kincise 2 head impactor, and then cracked in half.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855089 ↗MalfunctionSep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50679037 ↗MalfunctionAug 31, 2026Fracture
It was reported that the surgeon attempted to use the K2 head impactor on the 36-2 ball while implanting it onto an Sz 7 STD Actis Collared Stem during surgery. The patient was overweight, so he could not place the ball fully onto the trunnion by hand. When the head impactor contacted the 36-2 head, the ball cracked in half. All available information has been disclosed.DOE: 08-11-2026Affected Side: Right.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50527175 ↗MalfunctionApr 27, 2026Fracture
IT WAS REPORTED THAT WHILE IMPLANTING THE CERAMIC HEAD ON TO THE STEM THE FEMORAL HEAD IMPLANT BROKE. DOE- (B)(6) 2026. AFFECTED SIDE- RIGHT HIP.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25001884 ↗InjuryApr 24, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO RECURRING DISLOCATIONS. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 24985113 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN. AFFECTED SIDE: UNKNOWN.
Patient problems: Pain
MAUDE report 24778989 ↗MalfunctionMar 4, 2026Fracture
IT WAS REPORTED THAT UPON IMPLANTING THE HEAD, USER USED THE KINCISE TO IMPACT THE HEAD ONTO THE FEMORAL STEM AND THE ENTIRE HEAD SHATTERED INTO THREE PIECES. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506132 ↗InjuryJan 29, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE HIP WAS DISLOCATED. THERE WAS NO DELAY AND NO HARM TO PATIENT. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24212870 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT'S JOINT SPACE WAS INFECTED. THEREFORE, ALL HARDWARE WAS REMOVED. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24086947 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD INFECTION IN THE HIP. SURGEON RETAINED ALL COMPONENTS; EXCEPT THEY CHANGED OUT THE LINER AND THE HEAD AND DID IRRIGATION AND DEBRIDEMENT. DOI: (B)(6) 2025. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24058514 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS I&D FOR INFECTION. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 24053032 ↗InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS PATIENT HAD HER HIP REPLACED BY THE SURGEON ON (B)(6) 2025 AT THE HOSPITAL. THE PATIENT DID WELL INITIALLY BUT BEGAN TO EXPERIENCE PAIN AND HAS DRAINAGE COMING FROM HER SURGICAL WOUND. THE SURGEON DECIDED TO BRING THE PATIENT IN FOR A THOROUGH I&D WHERE HE EXPLANTED THE FEMORAL HIP BALL AND EMPHASYS LINER. THE ACTIS STEM AND EPHESUS ACETABULAR CUP WAS LEFT IN SITU. A NEW HIP BALL AND EMPHASYS LINER WERE IMPLANTED. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fluid Discharge; Pain
MAUDE report 23685125 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO INFECTION. MODERATE METAL TRANSFER NOTED ON THE FEMORAL HEAD.
Patient problems: Unspecified Infection
MAUDE report 23467184 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 23457610 ↗InjurySep 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED IN PACU. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22977184 ↗InjurySep 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISLOCATION. CONVERTED TO A DUAL MOBILITY. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22964542 ↗InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO CONCERN FOR A POSSIBLE INFECTION; THE SURGEON PERFORMED A WASHOUT WITH A HEAD AND LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 22829456 ↗InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT WASH OUT. AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 22642298 ↗InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22140186 ↗InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT UNDERWENT REVISION OF TOTAL HIP FOR INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 21333087 ↗InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION APPROXIMATELY TWO MONTHS POSTOP. THEY REMOVED ALL COMPONENTS AND IMPLANTED CEMENT SPACERS. DOI: UNKNOWN. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 21160050 ↗InjuryJan 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. SO SURGEON REVISED AND REPLACED HEAD. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 21124156 ↗InjuryOct 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED A LEFT HIP REVISION OCCURRED ON (B)(6) 2024. PATIENT DISLOCATED AFTER A FALL. DATE OF IMPLANT IS UNKNOWN.
Patient problems: Fall; Joint Dislocation
MAUDE report 20521850 ↗InjuryOct 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING. REVISED CUP TO EMPHASYS DUAL MOBILITY. UNKNOWN SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 20359058 ↗
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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