ARTICUL/EZE 4734-36-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295505709), received between Sep 9, 2024 and Jul 27, 2026 — classified as 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the surgeon did a wash out and replaced liner and femoral head due to an infection.DOI: unknown,DOR: ON (b)(6) 2026,Affected side: Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50012926 ↗
• InjuryJul 10, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. PATIENT'S HIP WAS CONVERTED TO DM AND PUT NEW CUP IN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25778221 ↗
• InjuryJun 30, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING. THE SURGEON REVISED TO DUAL MOBILITY. AFFECTED SIDE-LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25667268 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Pain

  MAUDE report 25457194 ↗
• InjuryMar 26, 2026Device Dislodged or Dislocated

  PATIENT WAS BEING REVISED DUE TO RECURRENT DISLOCATION. THE 52X36 NEUTRAL LINER AND 36MM 1.5 HEAD WERE REMOVED. DOCTOR IMPLANTED A CONSTRAINED +4 NEUTRAL LINER AND REVISION CERAMIC 32MM +1 FEMORAL HEAD. THERE WAS NO PREVIOUS REVISION. THE PATIENT WAS CONSIDERED TO HAVE RECURRENT DISLOCATIONS BECAUSE THEY HAD PREVIOUSLY DISLOCATED AND THE SURGEON PERFORMED A CLOSED REDUCTION. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Joint Dislocation

  MAUDE report 24705310 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO IRRIGATION AND DEBRIDEMENT WITH HEAD AND LINER EXCHANGED. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 24686554 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LIMB LENGTH DISCREPANCY. THE SURGEON REPLACED HEAD WITH LONGER ONE. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 24431277 ↗
• InjuryFeb 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT CLAIMED TO BE DISLOCATING, SO REMOVED HEAD AND LINER FOLLOWED BY CONVERSION TO A DUAL MOBILITY SYSTEM. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24317194 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENTS HIP WAS REVISED DUE TO INSTABILITY. DURING THE REVISION PROCEDURE, THE PATIENT'S PRIMARY FEMORAL HEAD, ACETABULAR LINER, AND ACETABULAR SHELL WERE REMOVED. THEY WERE REPLACED BY AN EMPHASYS MULTIHOLE ACETABULAR SHELL AND DUAL MOBILITY COMPONENTS FOR ADDED STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24245042 ↗
• InjuryJan 22, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A 36 1.5 HEAD WAS IMPLANTED INTO A 40 LINER. IT WAS FIRST NOTICED ON POST-OP X-RAY AND IS SCHEDULED TO BE TAKEN OUT AND REPLACED WITH A 40MM HEAD. AFFECTED SIDE-UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24143916 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PRIMARY HIP DONE IN (B)(6). SHE WAS BROUGHT BACK FOR A LINER/HEAD SWAP DUE TO POSSIBLE INFECTION. THE PINNACLE LINER AND 36MM CERAMIC HEAD WERE REMOVED AND REPLACED WITH A NEW LINER AND A REVISION CERAMIC HEAD. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23877099 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF LINER & HEAD DUE TO POST OP INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23596838 ↗
• InjuryNov 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A SIZE 6 HO ACTIS, EMPHASYS 3 HOLE CUP SIZE 54 WITHOUT SCREWS, NEUTRAL 54X36 LINER AND 36X 1.5 ARTICULEZE CERAMIC HEAD IMPLANTED ONE YEAR AGO. ANTERIOR APPROACH. THE SURGEON STATED THAT THE PATIENT HAD ONE EPISODE OF A 'MISSTEP' WHERE THE PATIENT DISLOCATED ANTERIORLY. REDUCTION WAS PERFORMED CLOSED WITHOUT FURTHER DISLOCATIONS. THE SURGEON NOTED THAT THE PATIENT CONTINUES TO REPORT THAT THE HIP FEELS ABNORMAL AND UNSTABLE. PATIENT WAS BROUGHT TO THE OR AND THE HEAD AND LINER WAS REMOVED. AN EMPHASYS 54MM LINER WAS IMPLANTED WITH A 28X5MM CERAMIC TS HEAD. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23470821 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH WASHOUT WITH LINER AND HEAD REPLACEMENT DUE TO POSSIBLE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22700700 ↗
• InjuryJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR DISLOCATION. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22493258 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WASH OUT DUE TO POOR SKIN HEALING. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Impaired Healing

  MAUDE report 22318980 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON DID WASHOUT AND SWAPPED LINER AND HEAD. NOTHING TO DO WITH IMPLANTS. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 22289531 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY, HEADBALL WAS SWAPPED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22080072 ↗
• InjuryApr 22, 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. SURGEON WAS GOING TO SWAP THE HEAD AND LINER, BUT THE STEM CAME OUT EASILY, POSSIBLY DUE TO SEPSIS. THERE WAS NON-CEMENTED LOOSENING OF THE FEMUR. SURGICAL DELAY WAS UNKNOWN. DOI: (B(6) 2025. DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 21881079 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21654810 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS 3 WEEKS POST THA. WOUND WAS VERY LONG AND PATIENT WAS NOT HEALING. WOUND AND WAS DRAINING CONSTANTLY. SURGEON OPENED THE WOUND AND FASCIA TO GO INTO JOINT TO WASHOUT AND REPLACE THE LINER AND HEAD WITH NEW COMPONENTS. SURGEON IMPLANTED A NEW LINER AND WENT UP TO A 36MM +5 TS HEAD TO MINIMIZE RISK OF SURGICAL SITE INFECTION DUE TO THE DELAYED HEALING. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 20853169 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES: A. WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? YES THE PATIENT HAD TO HAVE HIP REMOVED DUE TO INFECTION. NO CLAIMS WERE MADE ABOUT THE PRODUCT BEING DEFECTIVE, HOWEVER THE PATIENT HAD TO HAVE HIP REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 20614182 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR ACUTE INFECTION. WASH OUT WITH HEAD AND LINER EXCHANGE. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20534525 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO IRRIGATION AND DEBRIDEMENT WITH HEAD AND LINER EXCHANGE DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20267637 ↗
• MalfunctionSep 9, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  ADDITIONAL INFORMATION WAS RECEIVED, STATING THAT THE ONLY DELAY WAS OPENING A NEW HEAD. THERE WERE NO REPORTED STERILITY ISSUES, JUST A SLIGHT MARK ON THE DOME OF THE HEAD. THE SURGEON REQUESTED A NEW CERAMIC. NO PATIENT HARM OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 20168120 ↗