Arcos Modular Revision Hip System 11-301013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304480346), received between Sep 28, 2021 and May 28, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO MONTHS POST-IMPLANTATION. IT WAS NOTED, THE PROXIMAL BODY OR STEM SEEMS TO HAVE ROTATED, PLAN WAS TO REVISE PROXIMAL BODY HOWEVER THE PROXIMAL BODY COULD NOT BE MOVED, AND THE SCREW SEEMED CROSS THREADED, SO SURGEON REMOVED ENTIRE COMPONENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Aseptic loosening

  MAUDE report 25315618 ↗
• MalfunctionSep 28, 2021Degraded; Separation Failure; Degraded; Separation Failure

  IT WAS REPORTED THAT THE SURGEON PREPARED AND IMPLANTED THE DISTAL STEM. THE PROXIMAL REAMER WAS USED TO PREPARE THE PROXIMAL FEMUR. THE SURGEON REAMED UP TO D. THE D 60 STANDARD WAS IMPLANTED WITH THE GREEN PROXIMAL BODY INSERTER HANDLE AND THEN USING THE TORQUE LIMITING T HANDLE THE SCREW WAS SCREWED DOWN. REDUCTION WAS DONE WITH IMPLANTS IN PLACE. THE SURGEON NEEDED TO CHANGE THE VERSION OF THE PROXIMAL BODY. HE WAS HANDED THE 3.5 DRIVER TO UNDO THE SCREW AND COULD NOT REMOVE THE SCREW IT WAS STRIPPED. HE NEEDED TO REMOVE THE WHOLE CONSTRUCT AND REPLACE THE ITEMS WITH NEW ONES. NO ADVERSE CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541461 ↗