Arcos Modular Revision Hip System 11-300817Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00880304474253), received between Jun 29, 2021 and Apr 3, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Migration

  IT WAS REPORTED THAT THE PATIENT HAD A FAILED HIP RESURFACING SURGERY WHICH WAS TREATED WITH CONVERSION TO TOTAL HIP. DUE TO BEARING COMPATIBILITY AND ACETABULAR DEFECT THE ACETABULAR COMPONENT WAS LEFT INSITU AND AN ARCOS HIP STEM WITH LDH DM HEAD WAS IMPLANTED. THE STEM SUBSIDED NECESSITATING ITS REMOVAL AND SUBSEQUENT REVISION OF THE FEMORAL SIDE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 24778098 ↗
• InjuryMar 31, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED BY THE SURGEON IMPLANTED AN ARCOS STS 17 X 150 STEM. THE SURGEON REMOVED THE STEM AS IT WAS NOT IMPLANTED DEEP ENOUGH AND WANTED TO REAM FURTHER. THE SURGEON USED A SLAP HAMMER FROM ANOTHER COMPANY AND THREADED THE SLAP HAMMER INTO THE ARCOS STS STEM, BUT THE THREAD STRIPPED OUT OF THE ARCOS IMPLANT. SURGEON THEN ATTACHED THE BLACK HANDLE IMPACTOR FROM THE ARCOS INSTRUMENTS. THE SURGEON TRIED TO KNOCK THE STEM OUT, THE IMPACTOR BROKE LEAVING THE THREAD INSIDE THE TOP OF THE STEM.

  Patient problems: Failure of Implant

  MAUDE report 21730377 ↗
• MalfunctionJan 24, 2025Difficult to Insert; Difficult to Insert

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231207 ↗
• MalfunctionOct 28, 2024Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546841 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 19518615 ↗
• InjuryJun 29, 2021Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE TAPER DISASSEMBLY TOOL WAS FOUND TO BE CROSS-THREADED ON THE TAPER CONE AND THE SURGEON WAS UNABLE TO REMOVE THE TAPER FROM THE STEM. THE SURGEON THEN OPTED TO PERFORM AN ETO TO REMOVE THE STEM, TAPER AND DISASSEMBLY TOOL ALL IN ONE PIECE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 12087822 ↗