Wagner Cone Prosthesis® 01.00569.216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024282513), received between Mar 15, 2023 and Mar 15, 2023 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K113556); 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.

• MalfunctionMar 15, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING THE SURGERY OF THE RIGHT HIP AT TIME OF IMPLANTATION THE IMPLANT SIZE 16 MM WENT IN LOOSE SO THE SURGEON CHANGED TO SIZE 18 MM IMPLANTED AND WENT IN WITHOUT ISSUE. DUE DILIGENCE WAS PERFORMED; TO DATE WHATEVER ADDITIONAL INFORMATION RECEIVED, ALL HAVE BEEN INCLUDED IN THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 16545941 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113556. One submission often covers many models, so check the product and lot details in each record.

• Z-0221-2013 · Sep 4, 2012 · Terminated
  Wagner cone Prosthesis, uncemented, sterile, Rx