Arcos Modular Revision Hip System 11-301323Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304474666), received between Mar 9, 2021 and Apr 11, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Separation Failure” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT APPROXIMATELY THREE DAYS POST-IMPLANTATION, THE PATIENT WAS REVISED BECAUSE THE HEAD CAME OFF THE TRUNNION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 19087260 ↗
• InjuryFeb 25, 2022Separation Failure; Material Deformation; Separation Failure; Material Deformation

  IT WAS REPORTED THAT DURING A HIP REVISION DUE TO LIMB LENGTH DISCREPANCY, THE SURGEON REMOVED THE LOCKING SCREW FROM THE ARCOS STEM COMPONENTS AND FOUND THE THREADS OF THE PROXIMAL BODY TO BE STRIPPED. THE PROXIMAL BODY WAS UNABLE TO BE REMOVED FROM THE DISTAL STEM. CONSEQUENTLY, THE SURGEON DECIDED TO ABORT THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 13597790 ↗
• 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 12087789 ↗
• InjuryJun 11, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 1.5 YEARS POST IMPLANTATION DUE TO LIMB LENGTH DISCREPANCY. DURING THE REVISION, THE THREADS ON THE PROXIMAL BODY WERE FOUND TO BE STRIPPED AND THE SURGEON WAS UNABLE TO REMOVE THE PROXIMAL BODY FROM THE DISTAL STEM. THE SURGEON OPTED TO ABORT THE SURGERY WITHOUT REMOVED THE STEM. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Necrosis; Swelling/ Edema; Unequal Limb Length

  MAUDE report 11981788 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 11446918 ↗