Arcos Modular Revision Hip System 11-301342Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304474208), received between Jul 6, 2022 and Mar 25, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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-2273-2021 · 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.

• InjuryMar 25, 2026Unstable; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISIONS SURGERY APPROXIMATELY 2 MONTHS POST-IMPLANTATION DUE TO PRE-EXISTING CONDITIONS OF INFECTION, SYNOVITIS, STIFFNESS, AND AN OPEN WOUND. DURING THE PROCEDURE, IT WAS NOTED THAT THE WOUND WAS DRAINING AND A LARGE CALIBER VEIN ON THE POSTERIOR DISTAL THIGH WAS BLEEDING. THE FEMORAL COMPONENT HAD ROTATION INSTABILITY, AND THE PATIENT UNDERWENT A REVISION OF THE STEM, HEAD, AND LINER WITHOUT COMPLICATION. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.

  Patient problems: Hemarthrosis; Inadequate Osseointegration; Medical device site infection; Synovitis

  MAUDE report 24687398 ↗
• InjurySep 9, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION DUE TO THE TROCHANTERIC BOLT BACKING OUT OF THE SCREW HOLE THAT IS USED TO SECURE THE TROCHANTERIC CLAW TO THE PROXIMAL BODY. IT HAS NOT BEEN CONFIRMED WHICH COMPONENTS WERE REVISED, BUT A SCREW WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 23003857 ↗
• InjuryJul 8, 2025Adverse 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: Pain; Unequal Limb Length

  MAUDE report 22435149 ↗
• InjuryJul 6, 2022Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 8 WEEKS POST IMPLANTATION DUE TO THE ARCOS DISTAL SLOTTED STEM SUBSIDING. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 14934159 ↗