Arcos Modular Revision Hip System 11-301312Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304474093), received between May 29, 2020 and Apr 7, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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-2264-2021 · 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.

• InjuryApr 7, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 1-YEAR POST IMPLANTATION DUE TO A BROKEN ARCOS STEM. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 24802693 ↗
• InjurySep 23, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE FOLLOWED BY A REVISION DUE TO INFECTION. DURING THE REVISION, A TROCHANTERIC FRACTURE WAS FOUND AND A LARGE PLATE AND BOLT WERE PLACED, ALONG WITH CERCLAGE CABLES FOR FIXATION. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND SWELLING APPROXIMATELY NINE (9) MONTHS LATER, UNDERWENT A PROCEDURE FOR POSSIBLE REMOVAL. DURING THE PROCEDURE, THE SCREW WAS FOUND COMPLETELY LOOSE, THE PLATE WAS WELL FIXED, AND A PROXIMAL CERCLAGE WAS BROKEN. THE BOLT WAS REMOVED AND THE PLATE WAS RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema

  MAUDE report 23125669 ↗
• InjuryMar 5, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant; Fall; Joint Dislocation

  MAUDE report 11420823 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO INFECTION. DURING THE PROCEDURE, THE PROXIMAL BODY WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 10102107 ↗