Arcos Modular Revision Hip System 11-301335Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304480483), received between Oct 23, 2024 and Oct 23, 2024 — classified as 1 injury.

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-2272-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2024Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth; Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE. DURING THE PROCEDURE, THERE WAS ISSUES WITH THE INSERTER. ATTEMPTS WERE MADE TO FIX THE PROXIMAL BODY TO THE DISTAL STEM IN A REAM-OVER TECHNIQUE. HOWEVER, IT WOULD NOT WORK DESPITE THE TECHNIQUE BEING UTILIZED. MULTIPLE ATTEMPTS WERE TRIED TO ASSEMBLE THE CORRECT INSTRUMENTATION TO NO AVAIL. THE SURGEON THEN ATTEMPTED TO FIX THE PROXIMAL BODY TO THE DISTAL STEM USING A BASTARDIZED TECHNIQUE TO FIX THE STEM AND PROXIMAL BODY TOGETHER. THERE WAS A 25-MINUTE DELAY DURING SURGERY DUE TO INSTRUMENTATION NOT WORKING. AFTER THE CASE, IT WAS DETERMINED THAT THE GREY INSERTION HANDLE WAS DAMAGED AND BURRED AT THE INSERTION END WHICH DID NOT ALLOW THE ASSEMBLY ROD TO ENTER. THERE WAS NO DAMAGE NOTED TO THE INSTRUMENT PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE STEM OR PROXIMAL BODY IMPLANTS. THE FOLLOWING DAY, AN X-RAY SHOWED THAT THE STEM AND PROXIMAL BODY HAD A DUBIOUS COUPLING. IT WAS ALSO NOTED THAT THE PROXIMAL BODY WAS HUNG UP ON THE MEDIAL CALCAR AND WAS NOT SEATED IN THE PROXIMAL REAMED BONE. THE SURG

  Patient problems: Failure of Implant

  MAUDE report 20517025 ↗