AS Columbus® REVISION NR566ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963177348), received between May 2, 2023 and May 2, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NR566Z - AS COLUMBUS REV FEM.SPACER POST.F6 5MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE FEMUR IMPLANT HAD WHITE PARTICLES ALL OVER THE FIRST STERILE PACKAGE. WHEN OPENING THE LAST STERILE BARRIER, WHICH FINAL FEMUR IMPLANT RESIDES, IT WAS NOTICED THAT BARRIER WAS ALREADY OPEN. THERE WAS NO BACKUP FEMUR IMPLANT SO THE SURGEON HAD TO DOWNSIZE THE FEMUR. THIS EVENT OCCURED DURING A TOTAL KNEE REVISION PROCEDURE. THE SECOND IMPLANT, FOR FEMORAL AUGMENT, HAD BLACK MATERIAL IN THE STERILE PACKAGING. AFTER DOING SOME INVESTIGATING, BOTH OF THESE ITEMS WERE FOUND TO BE COMPLETELY OPEN. ONE OF THEM EVEN HAD THE SCAN CODE REMOVED FROM THE PACKAGE. THESE ITEMS WERE REMOVED BY THE TECH THAT CHECKED THE SET IN AND SCRAPPED THEM. THERE WAS NO RED TAG ON THE ITEMS EITHER. ADDITIONAL INFORMATION WAS RECEIVED WHICH REVEALED THAT THE SURGEON HAD TO DOWN SIZE FEMUR TO ACCOMMODATE NEXT SIZE IMPLANT. REPORTEDLY, THIS WAS DONE BY TAKING MORE BONE LEADING TO A LONGER SURGERY. THIS EVENT PROLONGED THE SURGERY WITH ONE HOUR. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS:

  Patient problems: Alteration in Body Temperature; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16856195 ↗