Arcos Modular Revision Hip System 11-301352Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304473935), received between Jun 21, 2023 and Jul 9, 2026 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. DURING THE PROCEDURE, A TRIFLANGE WAS IMPLANTED WITH ZIMMER BIOMET LINER AND COMPETITOR STEM. PT HAD UNKNOWN MEDICAL EPISODE CAUSING HIM TO DISLOCATE HIP. SURGEON ATTEMPTED REDUCTION AND BROKE PT FEMUR IN THE PROCESS. THE PATIENT WAS REVISED APPROXIMATE 2 MONTHS POST-IMPLANTATION DUE TO THE DISLOCATION AND BONE FRACTURE. A CONSTRAINED LINER AND ARCOS STEM WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 25761549 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PERI-PROSTHETIC FEMUR FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 17278133 ↗
• DeathJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO WEEKS POST THE INITIAL PROCEDURE BECAUSE A PROPER FIT WAS NOT ABLE TO BE OBTAIN BETWEEN THE LINER AND THE SHELL DURING THE INITIAL PROCEDURE. THERE WAS THIS DELAY BETWEEN THE TWO PROCEDURES DUE TO NEEDING TO OBTAIN COMPATIBLE BLOOD PRODUCTS FOR THE PATIENT. THE SURGERY ITSELF WAS ALSO PROLONGED DUE TO NUMEROUS COMPLICATIONS INCLUDING EXCESSIVE BLEEDING, INCORRECT COMPONENT POSITIONING, FEMUR FRACTURE, AND ADDITIONAL DIFFICULTY WITH IMPLANT PLACEMENT. ULTIMATELY, SATISFACTORY IMPLANTATION WAS ACHIEVED AND THE PROCEDURE CONCLUDED. HOWEVER, THE PATIENT IS REPORTED TO HAVE EXPIRED WITHIN 4 HOURS AFTER THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Bone Fracture(s); Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17170147 ↗