Arcos Modular Revision Hip System 11-300814Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304474154), received between Sep 25, 2024 and May 15, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (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 8, 2018Class IITerminated

   Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

   Z-2820-2018 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-HIP PROCEDURE, THE PATIENT PRESENTED WITH SEPTIC SHOCK DUE TO MRSA INFECTION IN THE HIP. THEY HAD FEVERS, DIFFICULTY WALKING, SWELLING, ABSCESS, AND POSITIVE CULTURES FOR MRSA AND SEPTIC SHOCK. THE HEAD WAS EXCHANGED IN AN I&D PROCEDURE BEFORE THE STAGE ONE REVISION ONE MONTH LATER. OP RECORDS NOTE PURULENT FLUID, LARGE FASCIAL DEHISCENCE. ALL COMPONENTS WERE REPLACED WITH A CEMENT SPACER DURING STAGE ONE WITHOUT COMPLICATIONS. THE STAGE TWO REVISION TOOK PLACE FOUR MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Abscess; Ambulation or Postural Difficulties; Bacterial Infection; Medical device site infection; Purulent Discharge; Scar Tissue; Sepsis; Septic Shock; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25184332 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, A NONDISPLACED FRACTURE OCCURRED WHEN IMPLANTING THE FINAL STEM DESPITE PROPHYLACTIC CABLING. ADDITIONAL CABLES WERE USED FOR STABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Periprosthetic fracture

  MAUDE report 25151439 ↗
• InjuryNov 12, 2024Migration; Migration

  IT WAS REPORTED THAT APPROXIMATELY TEN MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO FEMORAL SUBSIDENCE. THE HEAD, PROXIMAL BODY, AND STEM WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20664926 ↗
• InjurySep 25, 2024Migration; Migration

  IT WAS REPORTED THAT APPROXIMATELY TEN MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO FEMORAL SUBSIDENCE. THE HEAD, PROXIMAL BODY, AND STEM WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20301024 ↗