Arcos Modular Revision Hip System 11-300818Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304474147), received between Jun 25, 2020 and Jul 8, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THE PATIENT WAS EXPERIENCING WORSENING LEFT HIP, GROIN, BUTTOCK AND THIGH PAIN, LIMITED DAILY ACTIVITIES, AND MILD LIMP STARTING APPROXIMATELY 2 MONTHS POST-IMPLANTATION. THE PATIENT WAS ALSO NOTED TO HAVE SOME EDEMA TO THE FOOT. THE SURGEON PROVIDED A SHOE LIFT TO THE PATIENT FOR LEG LENGTH DISCREPANCY AND PATIENT CONTINUED PHYSICAL THERAPY; HOWEVER, THIS DID NOT PROVIDE ANY RELIEF. THE SURGEON REFERRED THE PATIENT TO AN ORTHOTIST FOR A CUSTOM SHOE. PATIENT ALSO PROVIDED FLECTOR PATCH FOR PAIN.

  Patient problems: Pain; Unequal Limb Length

  MAUDE report 22435148 ↗
• InjuryJun 9, 2025Positioning Failure; Separation Failure; Positioning 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 22168689 ↗
• InjuryJan 23, 2024Malposition of Device; Malposition of Device

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

  Patient problems: Insufficient Information

  MAUDE report 18561865 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available

  MAUDE report 10194557 ↗