Arcos Modular Revision Hip System 11-301321Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304474314), received between Mar 15, 2022 and Oct 12, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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 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-2267-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INACCURATE LEG LENGTH. THE CONE BODY, STEM AND HEAD WERE REVISED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unequal Limb Length

  MAUDE report 23275520 ↗
• InjuryJul 7, 2025Fracture; Fracture

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION DUE TO A FRACTURED STEM. THE NECK WAS RETURNED AND WAS ALSO NOTED TO BE FRACTURED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22410730 ↗
• InjuryApr 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD A HIP REVISION DUE TO A RIGHT BROKEN STEM IMPLANT. THERE WERE NO SURGICAL COMPLICATIONS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19010939 ↗
• InjuryFeb 26, 2024Migration; Migration

  IT WAS REPORTED THE PATIENT HAD AN INITIAL TOTAL LEFT HIP ARTHROPLASTY PERFORMED ON AN UNKNOWN DATE WITH UNKNOWN IMPLANTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE ASSOCIATED WITH LOOSENING STEM. THE PATIENT WAS IMPLANTED WITH ZIMMER BIOMET DEVICES DURING THE REVISION SURGERY AND WAS REVISED FOR A SECOND TIME THREE YEARS POST IMPLANTATION FOR IMPLANT SUBSIDENCE.

  Patient problems: Insufficient Information

  MAUDE report 18779327 ↗
• InjuryNov 6, 2023Adverse 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: Insufficient Information

  MAUDE report 18073427 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR A SECOND TIME APPROXIMATELY 13 YEARS LATER DUE TO METAL RELATED PATHOLOGY. AN EXTENDED TROCHANTERIC OSTEOTOMY WAS REQUIRED TO REMOVE THE WELL-FIXED STEM WHICH ALSO RESULTED IN FEMORAL FRACTURE REQUIRING AN OPEN REDUCTION INTERNAL FIXATION TO FIXATE THE GREATER TROCHANTER TO THE FEMUR.

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture; Scar Tissue

  MAUDE report 18072699 ↗
• InjuryMar 15, 2022Inadequacy of Device Shape and/or Size; Loosening of Implant Not Related to Bone-Ingrowth; Inadequacy of Device Shape and/or Size; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNDERSIZED IMPLANT, LOOSENING, AND INFECTION APPROXIMATELY 3 YEARS POST IMPLANTATION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 13774594 ↗