Active Articulation™ Dual Mobility 010000993Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304527416), received between May 24, 2024 and May 24, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K110555, K150522, K161190); they may or may not involve this specific model.

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 16, 2026.

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.

• InjuryMay 24, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER STATES THAT PATIENT PRESENTED AT FOLLOW UP WITH ELEVATED METAL LEVELS. CUSTOMER PERFORMED REVISION SURGERY TO REPLACE THE DUAL MOBILITY CONSTRUCT. IT WAS NOTED DURING THE REVISION SURGERY THAT LINER APPEARED UNAFFECTED, AND FEMORAL HEAD APPEARED AFFECTED. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: High metal ion levels

  MAUDE report 19397359 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110555, K150522, K161190. One submission often covers many models, so check the product and lot details in each record.

• Z-1284-2023 · Feb 6, 2023 · Open, Classified
  G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
• Z-1025-2017 · Dec 19, 2016 · Terminated
  Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
• Z-1024-2017 · Dec 19, 2016 · Terminated
  RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223