AS Columbus® REVISION F NR016ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963175382), received between May 2, 2023 and Mar 19, 2026 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED FAILURE OF A RIGHT KNEE PROSTHESIS THAT REQUIRED REVISION SURGERY. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2025, THE PATIENT UNDERWENT REVISION ARTHROPLASTY OF THE RIGHT KNEE DUE TO A FAILED RIGHT TOTAL KNEE REPLACEMENT. THE OPERATIVE REPORT INDICATES THAT THE FEMORAL AND TIBIAL COMPONENTS WERE GROSSLY LOOSE, WITH MINIMAL CEMENT ADHERENCE NOTED. THE SURGEON DOCUMENTED A SUSPECTED CEMENT ADHESION ISSUE ASSOCIATED WITH THE PRIOR IMPLANT. THE EXISTING PROSTHETIC COMPONENTS WERE EASILY REMOVED WITH MINIMAL BONE LOSS. THE FEMUR AND TIBIA WERE PREPARED AND REVISION COMPONENTS WERE IMPLANTED USING BONE CEMENT. TRIALING REPORTEDLY DEMONSTRATED APPROPRIATE ALIGNMENT AND STABILITY THROUGH RANGE OF MOTION. THE WOUND WAS IRRIGATED AND CLOSED IN LAYERS, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED IN THE OPERATIVE RECORD.

  Patient problems: Failure of Implant

  MAUDE report 24639439 ↗
• InjuryApr 1, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV F FEMUR CEMENTED F6R (PART# NR016Z) WAS IMPLANTED ON (B)(6) 2021. ACCORDING TO THE COMPLAINT DESCRIPTION, A SURGERY TO REPLACE THE POLYETHYLENE COMPONENT(S) HAD BEEN PLANNED. DEBRIDEMENT OF SCARRING ON THE RIGHT KNEE WOULD ALSO BE PERFORMED. THE PATIENT EXPERIENCED DECREASED RANGE OF MOTION IN THE RIGHT KNEE AND PAIN. THE POLYETHYLENE REPLACEMENT WOULD LIKELY BE SMALLER IN SIZE. THE PROCEDURE WAS PLANNED FOR (B)(6) 2025 THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS 3005673311-2025-00010, 3005673311-2025-00011, 3005673311-2025-00012, 3005673311-2025-00013, 3005673311-2025-00014, 3005673311-2025-00016, 3005673311-2025-00017, 3005673311-2025-00018.

  Patient problems: Loss of Range of Motion

  MAUDE report 21741340 ↗
• InjuryMay 2, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NR016Z - AS COLUMBUS REV F FEMUR CEMENTED F6R. ACCORDING TO THE COMPLAINANT, 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: 9610612-2023

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

  MAUDE report 16856196 ↗