AS Columbus® REVISION F NR003ZRecalls & reported problems

Aesculap AG · AS COLUMBUS REV F FEMUR CEMENTED F3L · Class 2 · Implant

All models of AS Columbus REVISION F (10)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963175276), received between Oct 14, 2020 and Aug 28, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Loosening of Implant Not Related to Bone-Ingrowth1
Patient-Device Incompatibility1

Patient problems

Ambulation or Postural Difficulties1
Implant Pain1
Metal Related Pathology1
Pain1
Swelling/ Edema1

Recent adverse event reports

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

InjuryAug 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2023.
Patient problems: Implant Pain; Metal Related Pathology
MAUDE report 22913053 ↗
InjuryOct 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AS COLUMBUS KNEE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLLING, DIFFICULTY WALKING AND LOOSENING OF THE DEVICE. THE PRIMARY PROCEDURE OCCURRED ON AN UNSPECIFIED DATE, AND THE REVISION WAS PERFORMED ON (B)(6) 2017. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NR003Z (PS FEMUR CEMENTED F3L). NR400Z (FEMUR STEM NUT ALL SIZES NEUTRAL). NR291Z (FEMORAL STEM CEMENTED 6° NEUT D12X77MM). NR072Z (PS TIBIA CEMENTED T1+). NR191Z (TIBIAL OFFSET STEM CEMENTED D12X52MM). NR614M (PS HC PE INSERT T1/T1+ 18MM). THE CEMENT USED IS UNIDENTIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00466, 2916714-2020-00467, 2916714-2020-00468, 2916714-2020-00469, 2916714-2020-00470.
Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema
MAUDE report 10679368 ↗

Device details

UDI-DI	`04046963175276`
Brand	AS Columbus® REVISION F
Model	NR003Z
Company	Aesculap AG
Product code	JWH · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Nov 13, 2025

Device type (GMDN): Uncoated knee femur prosthesis, metallic

An implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

ATTUNE 1506-00-005
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
589 reports
ATTUNE 1506-00-004
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
580 reports
JOURNEY 74012812
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
502 reports
JOURNEY 74011856
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
438 reports
PERSONA™ 42-5099-094-00
Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
406 reports
JOURNEY 74011857
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
388 reports
ATTUNE 1506-00-007
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
288 reports
ATTUNE 1506-00-003
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
271 reports

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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