ARTICUL/EZE 4734-28-085Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295506294), received between Jan 23, 2024 and Aug 13, 2025 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 22793188 ↗
• 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. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 20666502 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO DISLOCATION. THE HIP COULD NOT BE REDUCED UNDER SEDATION, SO THE SURGEON PERFORMED AN OPEN REDUCTION PROCEDURE. DURING THE PROCEDURE, THE SURGEON REMOVED AND REPLACED THE PATIENT'S ORIGINAL BI-POLAR HEAD CONSTRUCT WITH A LONGER UNI POLAR HEAD CONSTRUCT, TO INCREASE THE PATIENT'S LEG LENGTH AND FEMORAL OFFSET FOR INCREASED STABILITY. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Physical Asymmetry

  MAUDE report 18565068 ↗