Arcos Modular Revision Hip System 11-301300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304474611), received between Jan 6, 2022 and Oct 15, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 2, 2021Class IITerminated

   Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

   Z-2259-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 5 WEEKS LATER DUE TO DISLOCATION. DURING THE REVISION, THE DISTAL SCREW WAS ENGAGED HOWEVER THE PROXIMAL BODY WAS LOOSE AND ABLE TO ROTATE. THE PROXIMAL BODY, HEAD AND LINER WERE REVISED TO A LONGER CONSTRUCT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Joint Dislocation

  MAUDE report 23277299 ↗
• InjuryJun 9, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A STEM REVISION APPROXIMATELY 1 MONTH LATER TO CHANGE THE ANTEVERSION OF THE STEM. DURING THE PROCEDURE, THE SCREW REMAINED BLOCKED AND IMPOSSIBLE TO REMOVE. THIS REQUIRED COMPLETE REMOVAL OF THE FEMORAL IMPLANT AND PROXIMAL BODY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22168593 ↗
• InjuryJan 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 21123891 ↗
• MalfunctionNov 15, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696027 ↗
• MalfunctionJul 15, 2024Separation Failure; Damaged Thread; Separation Failure; Damaged Thread

  IT WAS REPORTED THAT DURING A REVISION FOR DISLOCATION, THE PROXIMAL BODY COULD NOT BE REMOVED FROM THE STEM BECAUSE IT WAS STRIPPED. THE STEM AND PROXIMAL BODY WERE UNABLE TO BE REVISED AND REMAIN IMPLANTED. THERE ARE NO PLANS TO REMOVE THE ITEMS AT A LATER DATE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742889 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Nerve Damage; Pain

  MAUDE report 17010631 ↗
• InjuryJan 6, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED A PATIENT UNDERWENT HIP REVISION SURGERY APPROXIMATELY 2.5 YEARS POST IMPLANTATION DUE TO INFECTION, PERIPROSTHETIC FRACTURE, MALUNION AND LOOSENING. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Malunion of Bone; Unspecified Infection

  MAUDE report 13178780 ↗