ARTICUL/EZE 1365-12-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 202 adverse event reports that list this exact device (DI 10603295033080), received between Jun 28, 2017 and Sep 11, 2026 — classified as 196 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (60 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 202 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Device Dislodged or Dislocated

  Patient problems: Fall; Joint Dislocation; Joint Laxity

  MAUDE report 50739603 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 25531831 ↗
• InjuryApr 29, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25036038 ↗
• InjuryFeb 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD DISLOCATED TWICE SINCE HIP HEMIARTHROPLASTY. CONVERSION TO TOTAL HIP WITH MULTIHOLE GRIPTION CUP, 7 SCREWS AND +4 10 DEGREE LINER. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24414497 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 24221932 ↗
• InjuryJan 30, 2026Device Dislodged or Dislocated

  THE PATIENT HAD A DISLOCATION OF LEFT HIP. DOI: (B)(6) 2019. DOR: (B)(4) 2026. AFFECTED SIDE: LEFT HIP. DOI: (B)(6) 2019 DOR: (B)(4) 2026 AFFECTED SIDE: LEFT HIP

  Patient problems: Joint Dislocation

  MAUDE report 24221852 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 24116831 ↗
• InjuryJan 20, 2026Device Dislodged or Dislocated

  PATIENT WAS DISLOCATED WITH +5 HEAD BALL. PATIENT WENT BACK IN WITH +15.5. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24116189 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR CUP AND LINER INSTABILITY, 25MM SCREW HEAD BROKE OFF WHEN TRYING TO EXTRACT SCREW. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23821882 ↗
• InjuryDec 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED A CONSTRAINED LINER. THERE WAS LOOSENING OF THE CUP AT THE NON-CEMENTED INTERFACE. THERE WERE NO DELAY, OR NO HARM TO PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE FOR REPORTING. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23795202 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL. A LARGE HEMOTOMA WAS REMOVED. HEAD AND CUP WERE SWAPPED. AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Hematoma

  MAUDE report 23703780 ↗
• InjuryOct 15, 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. THE SURGEON PERFORMED A HIP WASH OUT AND EXCHANGED BIMENTUM LINER AND HEAD. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23284968 ↗
• InjurySep 2, 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 INSTABILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22936777 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PERIPROSTHETIC FRACTURE OF THE FEMUR, PATIENT COMPLAINED OF LEG LENGTH DISCREPANCY PRIOR TO FRACTURE, POLY LINER AND HEAD WERE CHANGED TO INCREASE LEG LENGTH. AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Physical Asymmetry

  MAUDE report 22607672 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22585716 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD RIGHT HIP PAIN WITH SUSPECTED INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22560473 ↗
• InjuryJul 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO HIP DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 22519494 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD I AND D WITH POLY AND HEAD SWAP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22507081 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DISLOCATED INDEX HEMI HIP CONSTRUCT AND IS BEING REVISED DUE TO MODE OF FAILURE BEING INSTABILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22468046 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO METALOSIS AND REPLACED WITH POLYURETHANE LINER AND CERAMIC TS HEAD. NO SURGICAL DELAY. NO INFECTION. THERE WERE NO PATIENT CONSEQUENCES. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 22228297 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD AN EXISTING HEMI HIP WITH AN ACTIS STEM, 55MM BIPOLAR AND A 28MM +5 FEMORAL HEAD. THEY WERE BEING WASHED OUT FOR A SUSPECTED INFECTION. THE BIPOLAR HEAD AND 28MM FEMORAL HEAD WERE REMOVED AND REPLACED WITH NEW IMPLANTS OF THE SAME SIZE. ORIGINAL SURGICAL DATE WAS UNKNOWN. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22187045 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INSTABILITY. PER PATIENT, PRIMARY SURGERY WAS DONE AT CLINIC 26 YEARS AGO. REVISION WAS PERFORMED. DATE OF EVENT WAS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22114133 ↗
• InjuryMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A HEMI DONE IN (B)(6) 2024. PATIENT FELL AND DISLOCATED THEIR HIP. PATIENT WENT TO GET IT REDUCED AT A HOSPITAL, AND UPON REDUCING, THE INNER 28MM HEAD DISCONNECTED FROM THE OUTER BIPOLAR SHELL. SURGEON TOOK OUT BOTH THE 28MM INNER HEAD AND THE 55 BIPOLAR HEAD AND PLACED NEW COMPONENTS OF THE SAME SIZES. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21972179 ↗
• InjuryApr 17, 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: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21859078 ↗
• InjuryMar 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INNER PLASTIC RING OF BIPOLAR HEAD SHEARED OFF AND INNER HEAD DISLOCATED FROM BIPOLAR HEAD. THERE WAS A LOOSENING REPORTED AT BIPOLAR HEAD AND INNER HEAD CONSTRUCT. PATIENT WAS REVISED. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21687148 ↗