AS Columbus REVISION FRecalls & reported problems across all models

We found 10 models of AS Columbus REVISION F by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Oct 14, 2020 and May 1, 2026 — classified as 24 injuries.

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

Most reported AS Columbus REVISION F problems

AS Columbus REVISION F models

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

• AS Columbus® REVISION F NR071Z

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  6 reports
• AS Columbus® REVISION F NR005Z

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  4 reports
• AS Columbus® REVISION F NR016Z

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• AS Columbus® REVISION F NR003Z

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• AS Columbus® REVISION F NR004Z

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• AS Columbus® REVISION F NR013Z

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• AS Columbus® REVISION F NR074Z

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• AS Columbus® REVISION F NR076Z

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• AS Columbus® REVISION F NR073Z

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• AS Columbus® REVISION F NR077Z

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report

Recent AS Columbus REVISION F adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Patient-Device Incompatibility

  A LAW FIRM REPORTS THAT A PATIENT ALLEGES POST-OPERATIVE LOOSENING OF AESCULAP KNEE IMPLANT. REPORTEDLY THERE WAS ALLEGED PAIN AND SWELLING 1 YEAR, 5 MONTHS POST OPERATIVE AFTER THE REVISION OF THE LEFT KNEE. THE ADVERSE EVENT IS FILED UNDER AIS REFERENCE XC (B)(4).

  Patient problems: Implant Pain

  MAUDE report 25055814 ↗
• InjuryMar 23, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ISSUES FOLLOWING A LEFT KNEE PROSTHESIS THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED DECEMBER 15, 2022, A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. THE PROCEDURE WAS PERFORMED USING CEMENTED KNEE COMPONENTS (AESCULAP SYSTEM) WITH PALACOS BONE CEMENT. THE OPERATIVE REPORT INDICATES THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO INTRAOPERATIVE COMPLICATIONS, AND THE IMPLANTS WERE PLACED WITH APPROPRIATE ALIGNMENT AND STABILITY. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED DECEMBER 27, 2023, THE PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY DUE TO ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. INTRAOPERATIVELY, BOTH COMPONENTS WERE NOTED TO BE GROSSLY LOOSE, WITH NO CEMENT ADHERENT TO THE IMPLANTS. THE COMPONENTS WERE REMOVED WITHOUT SIGNIFICANT BONE LOSS. REVISION WAS PERFORMED USING STEMMED FEMORAL AND TIBIAL COMPONENTS, BONE CEMENT, AND ADJUNCTIVE MATERIALS INCLUDING ANTIBIOTIC BEADS. FINAL IMPLANTATION DEMONSTRATED STABLE FIXATION WITH APPROPRIATE ALIGNMENT AND FULL RANGE OF MOTION WITHOUT INSTABILITY. THE PATIENT TOLERATED THE PRO

  Patient problems: Failure of Implant

  MAUDE report 24661558 ↗
• 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. TRAILING 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 24639444 ↗
• 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 ↗
• 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 ↗
• 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 22913044 ↗
• 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 22306740 ↗
• InjuryApr 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS COLUMBUS REV F TIB.OFFSET CEMENT.T1 (PART# NR071Z) 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 MILLIMETER (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, 3005673311-2025-00022, 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 21755137 ↗
• InjuryApr 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT ANAS COLUMBUS REV F FEMUR CEMENTED F3R (PART# NR013Z) 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 MILLIMETER (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, 3005673311-2025-00027, 3005673311-2025-00028, AND 3005673311-2025-00029.

  Patient problems: Failure of Implant

  MAUDE report 21755124 ↗
• 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 ↗
• InjuryApr 1, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV F TIB.OFFSET CEMENT.T3+ (PART# NR076Z) 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 XC 100038781 CC 400702993. ASSOCIATED MEDWATCH REPORTS . 3005673311-2025-00011 3005673311-2025-00012 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 21741231 ↗
• InjuryOct 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV F TIB.OFFSET CEMENT.T2 (PART # NR073Z) 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)). 2916714-2024-00172 (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 20531896 ↗
• 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 ↗
• InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP AG THAT A AS TIBIA OFFSET STEM D12X52MM CEMENTED. (PART # NR191Z) WAS IMPLANTED DURING A LEFT KNEE REVISION SURGERY PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, POST-OPERATIVE BONE DETERIORATION OF FEMUR AND TIBIA OCCURRED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. A REVISION IN THE FUTURE IS LIKELY, ACCORDING TO THE PATIENT. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: (B)(4) - NR191Z (9610612-2022-00142); (B)(4) - NR291Z (9610612-2022-00143); (B)(4) - NR565Z (9610612-2022-00144); (B)(4) - NR565Z (9610612-2022-00145); (B)(4) - NR611M (9610612-2022-00146); (B)(4) - NR005Z (9610612-2022-00148); (B)(4)- NR400Z (9610612-2022-00149).

  Patient problems: Failure of Implant

  MAUDE report 14456572 ↗
• InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP AG THAT A AS COLUMBUS REV F FEMUR CEMENTED F5L (PART # NR005Z) WAS IMPLANTED DURING A LEFT KNEE REVISION SURGERY PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, POST-OPERATIVE BONE DETERIORATION OF FEMUR AND TIBIA OCCURRED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. A REVISION IN THE FUTURE IS LIKELY, ACCORDING TO THE PATIENT. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: (B)(4) - NR191Z (9610612-2022-00142). (B)(4) - NR291Z (9610612-2022-00143). (B)(4) - NR565Z (9610612-2022-00144). (B)(4) - NR565Z (9610612-2022-00145). (B)(4) - NR611M (9610612-2022-00146). (B)(4) - NR071Z (9610612-2022-00147). (B)(4) - NR005Z (9610612-2022-00148). (B)(4) - NR400Z (9610612-2022-00149).

  Patient problems: Failure of Implant

  MAUDE report 14456396 ↗

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