Wagner Cone Prosthesis® 01.00569.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024282339), received between Feb 17, 2021 and Feb 17, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2021Misassembled; Inadequacy of Device Shape and/or Size; Use of Device Problem; Patient Device Interaction Problem

  DURING SURGERY, THE SURGEON REAMED A 20X125 STEM AND PUT TOGETHER THE TRIAL. SINCE THE TRIAL SCREW WERE CROSS THREADED, HE IMPLANTED THE REAL STEM WITHOUT TRIALING. AS THE STEM SAT TOO LOW, HE EXPLANTED IT AND REAMED UP TO 21 BUT HE COULD NOT TRIAL AGAIN DUE TO ANOTHER CROSS THREADED SCREW IN THE TRIAL. THE SURGERY WAS COMPLETED USING A LONGER ARCOS STEM. SURGERY WAS DELAYED FOR 45 MINUTES. NOTE: THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE INVOLVED IN THIS COMPLAINT IS AN INSTRUMENT. HENCE, NO EXPIRATION DATE IS CAPTURED, FOR THE SAME REASON.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337364 ↗
• InjuryFeb 17, 2021Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337357 ↗

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