AS Columbus REVISIONRecalls & reported problems across all models

Aesculap AG · 13 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 23
Deaths reported: 0
Injuries reported: 22
Recalls: 0

We found 13 models of AS Columbus REVISION by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2021 and Aug 28, 2025 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

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

Most reported AS Columbus REVISION problems

Device problems

Patient-Device Incompatibility9
Device Appears to Trigger Rejection8
Mechanical Problem2
Adverse Event Without Identified Device or Use Problem1
Contamination /Decontamination Problem1
Device Ingredient or Reagent Problem1
Loosening of Implant Not Related to Bone-Ingrowth1
Material Split, Cut or Torn1

Patient problems

Failure of Implant14
Implant Pain8
Unspecified Infection4
Metal Related Pathology3
No Clinical Signs, Symptoms or Conditions3
Loss of Range of Motion2
Alteration in Body Temperature1
Ambulation or Postural Difficulties1

AS Columbus REVISION models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

AS Columbus® REVISION NR565Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
5 reports
AS Columbus® REVISION NR244Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
2 reports
AS Columbus® REVISION NR463Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
2 reports
AS Columbus® REVISION NR466Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
2 reports
AS Columbus® REVISION NR475Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
2 reports
AS Columbus® REVISION NR563Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
2 reports
AS Columbus® REVISION NR573Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
2 reports
AS Columbus® REVISION NR044Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
1 report
AS Columbus® REVISION NR464Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
1 report
AS Columbus® REVISION NR465Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
1 report
AS Columbus® REVISION NR566Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
1 report
AS Columbus® REVISION NR575Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
1 report
AS Columbus® REVISION NR584Z
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
1 report

Recent AS Columbus REVISION adverse event reports

The 15 most recent reports across all models, 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 22913059 ↗
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 22913058 ↗
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 22913050 ↗
InjuryJun 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2017, WITH IMPLANTATION OF A VEGA SYSTEM IN THE RIGHT KNEE. THE TIBIAL COMPONENT REPORTEDLY LOOSENED AND REQUIRED REVISION ON (B)(6) 2018, AT WHICH TIME THE VEGA SYSTEM WAS AGAIN USED FOR THE BOTTOM COMPONENT. ON (B)(6) 2019, A SECOND REVISION WAS PERFORMED AFTER THE FEMORAL COMPONENT REPORTEDLY FAILED, AND THE CONSTRUCT WAS REVISED TO A COLUMBUS AF SYSTEM. DESPITE THE REVISIONS, THE PATIENT CONTINUED TO EXPERIENCE INSTABILITY AND PAIN. ON (B)(6) 2022, A THIRD REVISION WAS PERFORMED, AND ALL AESCULAP COMPONENTS WERE REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. WHILE NO FURTHER MECHANICAL FAILURE HAS OCCURRED SINCE THAT SURGERY, THE PATIENT CONTINUES TO REPORT CHRONIC SWELLING, PAIN, AND LIMITED MOBILITY IN THE RIGHT KNEE. THE RIGHT KNEE IS NOW VISIBLY LARGER THAN THE LEFT, AND THE PATIENT REQUIRED A LEFT KNEE REPLACEMENT DUE TO OVERCOMPENSATION. THE EXPLANTED RIGHT KNEE COMPONENTS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Failure of Implant
MAUDE report 22307132 ↗
InjuryApr 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED TO AESCULAP INC. THAT AN AS COLUMBUS REV FEM.SPACER POST.F3 10MM (PART# NR573Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, A SURGERY TO REPLACE THE POLYETHYLENE COMPONENTS HAD BEEN PLANNED FOR (B)(6)2025; SIZES LARGER THAN 20 MILLIMETERS (MM) NEEDED. THE PROCEDURE WOULD BE REVISION RIGHT KNEE TOTAL ARTHROPLASTY (TKA). ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00019; 3005673311-2025-00020; 3005673311-2025-00021; 3005673311-2025-00022; 3005673311-2025-00023; 3005673311-2025-00024; 3005673311-2025-00026; 3005673311-2025-00027; 3005673311-2025-00028; 3005673311-2025-00029; 3005673311-2025-00030.
Patient problems: Failure of Implant
MAUDE report 21755193 ↗
InjuryApr 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED TO AESCULAP INC. THAT AN AS COLUMBUS REV FEM.SPACER DIST.F3 5MM (PART# NR463Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT A SURGERY TO REPLACE THE POLYETHYLENE COMPONENTS HAD BEEN PLANNED FOR (B)(6) 2025; SIZES LARGER THAN 20 MILLIMETERS (MM) NEEDED. THE PROCEDURE WOULD BE REVISION RIGHT KNEE TOTAL ARTHROPLASTY (TKA). ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00019. 3005673311-2025-00020. 3005673311-2025-00021. 3005673311-2025-00022. 3005673311-2025-00023. 3005673311-2025-00024. 3005673311-2025-00025. 3005673311-2025-00027. 3005673311-2025-00028. 3005673311-2025-00029. 3005673311-2025-00030.
Patient problems: Failure of Implant
MAUDE report 21755171 ↗
InjuryApr 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED TO AESCULAP INC. THAT AN AS COLUMBUS REV FEM.SPACER POST.F3 10MM (PART# NR573Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT A SURGERY TO REPLACE THE POLYETHYLENE COMPONENTS HAD BEEN PLANNED FOR (B)(6) 2025; SIZES LARGER THAN 20 MILLIMETERS (MM) NEEDED. THE PROCEDURE WOULD BE REVISION RIGHT KNEE TOTAL ARTHROPLASTY (TKA). ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE XC (B)(4). ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00019, 3005673311-2025-00020, 3005673311-2025-00021, 3005673311-2025-00022, 3005673311-2025-00023, 3005673311-2025-00025, 3005673311-2025-00026, 3005673311-2025-00027, 3005673311-2025-00028, 3005673311-2025-00029, 3005673311-2025-00030.
Patient problems: Failure of Implant
MAUDE report 21755139 ↗
InjuryApr 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED TO AESCULAP INC. THAT AN AS COLUMBUS TIB.HEMI-SP. T1/1+ 5MM RL/LM CEMENTED (PART# NR244Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT A SURGERY TO REPLACE THE POLYETHYLENE COMPONENTS HAD BEEN PLANNED FOR (B)(6) 2025; SIZES LARGER THAN 20 MILLIMETERS (MM) NEEDED. THE PROCEDURE WOULD BE REVISION RIGHT KNEE TOTAL ARTHROPLASTY (TKA). ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00019, 3005673311-2025-00021, 3005673311-2025-00022, 3005673311-2025-00023, 3005673311-2025-00024, 3005673311-2025-00025, 3005673311-2025-00026, 3005673311-2025-00027, 3005673311-2025-00028, 3005673311-2025-00029, 3005673311-2025-00030.
Patient problems: Failure of Implant
MAUDE report 21755138 ↗
InjuryApr 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED TO AESCULAP INC. THAT AN AS COLUMBUS REV FEM.SPACER DIST.F3 5MM (PART# NR463Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT A SURGERY TO REPLACE THE POLYETHYLENE COMPONENTS HAD BEEN PLANNED FOR (B)(6) 2025; SIZES LARGER THAN 20 MILLIMETERS (MM) NEEDED. THE PROCEDURE WOULD BE REVISION RIGHT KNEE TOTAL ARTHROPLASTY (TKA). ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00019. 3005673311-2025-00020. 3005673311-2025-00021. 3005673311-2025-00022. 3005673311-2025-00023. 3005673311-2025-00024. 3005673311-2025-00025. 3005673311-2025-00026. 3005673311-2025-00028. 3005673311-2025-00029. 3005673311-2025-00030.
Patient problems: Failure of Implant
MAUDE report 21755120 ↗
InjuryApr 1, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV FEM. SPACER DIST.F6 5MM (PART# NR466Z) 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, 3005673311-2025-00014, 3005673311-2025-00015, 3005673311-2025-00016, 3005673311-2025-00017, 3005673311-2025-00018.
Patient problems: Loss of Range of Motion
MAUDE report 21741252 ↗
InjuryApr 1, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV FEM. SPACER DIST.F6 5MM (PART#: NR466Z) 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 ON (B)(6) 2025. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE: (B)(4). ASSOCIATED MEDWATCH REPORTS 3005673311-2025-00010, 3005673311-2025-00011, 3005673311-2025-00013, 3005673311-2025-00014, 3005673311-2025-00015, 3005673311-2025-00016, 3005673311-2025-00017, 3005673311-2025-00018.
Patient problems: Loss of Range of Motion
MAUDE report 21741239 ↗
InjuryOct 29, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV FEM. SPACER DIST. F5 10MM (PART#: NR475Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE PATIENT WAS INFECTED AND REQUIRED A REVISION PROCEDURE. REPORTEDLY THE REVISION WAS PERFORMED ON (B)(6) 2024. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE: (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00162 (AIC REFERENCE NO. (B)(4), 2916714-2024-00165 (AIC REFERENCE NO. (B)(4), 2916714-2024-00166 (AIC REFERENCE NO. (B)(4), 2916714-2024-00167 (AIC REFERENCE NO. (B)(4), 2916714-2024-00168 (AIC REFERENCE NO. (B)(4), 2916714-2024-00169 (AIC REFERENCE NO. (B)(4), 2916714-2024-00172 (AIC REFERENCE NO. (B)(4), 2916714-2024-00173 (AIC REFERENCE NO. (B)(4), 2916714-2024-00174 (AIC REFERENCE NO. (B)(4), 2916714-2024-00175 (AIC REFERENCE NO. (B)(4).
Patient problems: Failure of Implant; Implant Pain; Unspecified Infection
MAUDE report 20561231 ↗
InjuryOct 29, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV FEM.SPACER DIST.F5 10MM (PART # NR475Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE PATIENT WAS INFECTED AND REQUIRED A REVISION PROCEDURE. REPORTEDLY THE REVISION WAS PERFORMED ON (B)(6) 2024. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00162 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00165 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00166 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00167 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00168 (AIC REFERENCE NO. (B)(4)). (AIC REFERENCE NO. (B)(4)). 2916714-2024-00171 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00172 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00173 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00174 (AIC REFERENCE NO. (B)(4)). 2916714-2024-00175 (AIC REFERENCE NO. (B)(4)).
Patient problems: Failure of Implant; Implant Pain; Unspecified Infection
MAUDE report 20561143 ↗
InjuryOct 29, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV FEM.SPACER POST.F5 5MM (PART # NR565Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE PATIENT WAS INFECTED AND REQUIRED A REVISION PROCEDURE. REPORTEDLY THE REVISION WAS PERFORMED ON (B)(6) 2024. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE(B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00162 (AIC REFERENCE NO.(B)(4) 2916714-2024-00165 (AIC REFERENCE NO. (B)(4) 2916714-2024-00166 (AIC REFERENCE NO.(B)(4) 2916714-2024-00167 (AIC REFERENCE NO. (B)(4)) 2916714-2024-00168 (AIC REFERENCE NO. 400681246) 2916714-2024-00169 (AIC REFERENCE NO. (B)(4)) 2916714-2024-00171 (AIC REFERENCE NO. (B)(4) 2916714-2024-00172 (AIC REFERENCE NO. (B)(4) 2916714-2024-00173 (AIC REFERENCE NO. (B)(4) 2916714-2024-00174 (AIC REFERENCE NO. (B)(4) 2916714-2024-00175 (AIC REFERENCE NO. (B)(4).
Patient problems: Failure of Implant; Implant Pain; Unspecified Infection
MAUDE report 20561011 ↗
InjuryOct 29, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV FEM. SPACER POST. F5 10MM (PART#: NR575Z) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE PATIENT WAS INFECTED AND REQUIRED A REVISION PROCEDURE. REPORTEDLY THE REVISION WAS PERFORMED ON (B)(6) 2024. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE: (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00162 (AIC REFERENCE NO. (B)(4), 2916714-2024-00165 (AIC REFERENCE NO. (B)(4), 2916714-2024-00166 (AIC REFERENCE NO. (B)(4), 2916714-2024-00167 (AIC REFERENCE NO. (B)(4), 2916714-2024-00168 (AIC REFERENCE NO. (B)(4), 2916714-2024-00169 (AIC REFERENCE NO. (B)(4), 2916714-2024-00171 (AIC REFERENCE NO. (B)(4), 2916714-2024-00173 (AIC REFERENCE NO. (B)(4), 2916714-2024-00174 (AIC REFERENCE NO. (B)(4), 2916714-2024-00175 (AIC REFERENCE NO. (B)(4).
Patient problems: Failure of Implant; Implant Pain; Unspecified Infection
MAUDE report 20560942 ↗

Other Aesculap AG products

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Sources and updates

Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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