ARTICUL/EZE 1365-25-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295033219), received between Aug 28, 2018 and Jul 7, 2025 — classified as 9 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K843909, K883460); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BECOME UNSTABLE AND UNDERWENT REVISION TO GET STABILITY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2002, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22420861 ↗
• InjuryOct 23, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  THE SURGEON NOTED PLACING A CONSTRAINED LINER DUE TO MULTIPLE DISLOCATIONS FOLLOWING THE FIRST REVISION.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Edema; Foreign Body Reaction; Inflammation; Joint Dislocation; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10727293 ↗
• InjuryApr 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8565223 ↗
• InjuryApr 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION WITH OPEN REDUCTION, INFECTION AND LOOSENING OF STEM AFTER FIRST REVISION. DOI: (B)(6) 2009 - DOR: (B)(6) 2009 (LEFT HIP) 2ND REVISION.

  Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 8509941 ↗
• InjuryApr 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION AFTER FIRST REVISION. LINER IS A COMPETITOR. DOI: (B)(6) 2004, DOR: (B)(6) 2005, (LEFT HIP) SECOND REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 8497723 ↗
• InjuryMar 6, 2019Fracture; Fracture

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AND FRACTURE AFTER FIRST REVISION. DOI: (B)(6) 2008 - DOR: (B)(6) 2009, (LEFT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8394075 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2010 - DOR: (B)(6) 2011, (LEFT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8366102 ↗
• InjuryNov 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY, CHRONIC DISLOCATION AND DAMAGED CUP DUE TO FRACTURED POLY.

  Patient problems: Injury; Joint Dislocation; No Code Available; Pain

  MAUDE report 8071384 ↗
• InjuryAug 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2010 - DOR: (B)(6) 2011 (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 7822075 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K843909, K883460. One submission often covers many models, so check the product and lot details in each record.

• Z-1845-2021 · May 7, 2021 · Terminated
  DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR