Columbus REVISION FRecalls & reported problems across all models

We found 14 models of Columbus REVISION F by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jul 6, 2020 and Mar 19, 2026 — classified as 22 injuries.

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

Columbus REVISION F models

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

• Columbus® REVISION F NR124M

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• Columbus® REVISION F NR076K

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• Columbus® REVISION F NR135M

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• Columbus® REVISION F NR121M

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• Columbus® REVISION F NR611M

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• Columbus® REVISION F NR615M

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• Columbus® REVISION F NR633M

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• Columbus® REVISION F NR015K

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Columbus® REVISION F NR074K

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Columbus® REVISION F NR132M

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Columbus® REVISION F NR115M

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Columbus® REVISION F NR147M

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Columbus® REVISION F NR612M

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• Columbus® REVISION F NR614M

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

Recent 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.

• 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 24639446 ↗
• 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 22913054 ↗
• InjuryAug 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NR615M - COLUMBUS REV F HC GLID.SURF.T1/1+ 20MM. ACCORDING TO THE COMPLAINT DESCRIPTION, A POLYSWAP WAS PLANNED DUE TO POSTOPERATIVE INFECTION. THE PATIENT CURRENTLY NEEDED THE SECOND STAGE OF A DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION (DAIR) PROCEDURE. THE ORIGINAL IMPLANTATION HAD BEEN IN 2019. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 22803536 ↗
• 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 22306739 ↗
• InjuryApr 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT AN COLUMBUS REV F HC GLID.SURF.T1/1+ 20MM (PART# NR615M) 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, 3005673311-2025-00029, 3005673311-2025-00030.

  Patient problems: Failure of Implant

  MAUDE report 21755122 ↗
• InjuryApr 1, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A COLUMBUS REV F MC GLID.SURF.T3/3+ 14MM (PART# NR132M) 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, 3005673311-2025-00015, 3005673311-2025-00016, AND 3005673311-2025-00018.

  Patient problems: Loss of Range of Motion

  MAUDE report 21741242 ↗
• InjuryOct 29, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP INC. THAT A COLUMBUS REV F MC GLID.SURF.T2/2+ 18MM (PART # NR124M) 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 20557888 ↗
• InjuryJan 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO AESCULAP INC. THAT A COLUMBUS REV F MC GLID.SURF.T2/2+ 18MM (PART # NR124M) WAS IMPLANTED DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE KNEE IMPLANT DISLOCATED POSTOPERATIVELY ON (B)(6) 2022. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. REPORTEDLY, THE DEVICE WAS REPLACED WITH A SIMILAR IMPLANT. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 16183483 ↗
• InjuryJan 13, 2023Device Dislodged or Dislocated; Manufacturing, Packaging or Shipping Problem; Device Dislodged or Dislocated; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NR124M - COLUMBUS REV F MC GLID.SURF.T2/2+ 18MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE JOINT DISLOCATED POSTOPERATIVELY ON (B)(6) 2022. A CLOSED REDUCTION WAS PLANNED AND PERFORMED ON 20DEC2022; THE T2 18 MC MM POLY WAS REPLACED WITH T2 20MM HC POLY. A REVISION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 16160898 ↗
• InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP INC. THAT A COLUMBUS REV F HC GLID.SURF.T1/1+ 12MM (PART # NR611M) 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. ACCORDING TO THE PATIENT , A REVISION SURGERY IN THE FUTURE IS LIKELY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: (B)(4)- NR191Z (2916714-2022-00055), (B)(4)- NR291Z (2916714-2022-00056), (B)(4)- NR565Z (2916714-2022-00057), (B)(4)- NR565Z (2916714-2022-00058), (B)(4)- NR071Z (2916714-2022-00060), (B)(4)- NR005Z (2916714-2022-00061), (B)(4)- NR400Z (2916714-2022-00062).

  Patient problems: Failure of Implant

  MAUDE report 14456426 ↗
• InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED AESCULAP AG THAT A COLUMBUS REV F HC GLID.SURF.T1/1+ 12MM (PART # NR611M) 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 14456095 ↗
• InjuryMay 18, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP AG THAT A THAT THERE WAS AN ISSUE WITH NR121M - COLUMBUS REV F MC GLID.SURF.T2/2+ 12MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE IMPLANT LOOSENED POST SURGERY. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 14431749 ↗
• InjuryMay 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A COLUMBUS KNEE IMPLANT (PART # NR121M) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED IN (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PATIENT COMPLAINED THAT HER KNEE FELT LOOSE AND UNSTABLE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, THE SURGEON OPENED THE PATIENT, DEBRINED THE AREA AND IMPLANTED A THICKER POLY AND TIGHTENED THE JOINT SPACE. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY AND IT WAS REPORTED THAT THE SURGERY ON (B)(6) 2022 WAS A REVISION OF A REVISION. THE DATE OF THE PREVIOUS REVISION IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 19, 2022 WHICH REVEALED THAT THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO INTRAOPERATIVE ISSUES AND NO REPORTS OF ANY POST OPERATIVE COMPLICATIONS. THE MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 14319954 ↗
• InjuryOct 21, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NR076K - COLUMBUS REV F TIBIA OFFSET CEMENTED T3+. IT WAS REPORTED ON (B)(6) 2018, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED LOOSENESS IN THE IMPLANT, PAIN AND DIFFICULTY WALKING, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2016. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. CEMENT USED: BIOMET MV BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00455 (400481542 + (B)(4)). INVOLVED COMPONENTS: NR015K - COLUMBUS REV F FEMUR CEMENTED F5R - 51869643. NR296K - FEMUR EXTENS.STEM 6° D18X157MM CEMENTED - 51622420. NR400K - NUT F/FEMUR EXTENS.STEM ALL SIZES NEUTR. - 52032922. NR196K - TIBIA OFFSET STEM D18X92MM CEMENTED - 51681838. NR133M - COLUMBUS REV F MC GLID.SURF.T3/3+ 16MM - 51885048. NR134M - COLUMBUS REV F MC GLID.SURF.T3/3+ 18MM - 52068453.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain

  MAUDE report 12676470 ↗
• InjuryAug 23, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NR076K - COLUMBUS REV F TIBIA OFFSET CEMENTED T3+. IT WAS REPORTED ON (B)(6) 2018, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED LOOSENESS IN THE IMPLANT, PAIN AND DIFFICULTY WALKING, WHICH RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2015, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2016. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. CEMENT USED: BIOMET MV BONE CEMENT. A REVISION SURGERY WAS NECESSARY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00455 (400481542 + NR015K). INVOLVED COMPONENTS: NR015K - COLUMBUS REV F FEMUR CEMENTED F5R - 51869643. NR296K - FEMUR EXTENS.STEM 6¿ D18X157MM CEMENTED - 51622420. NR400K - NUT F/FEMUR EXTENS.STEM ALL SIZES NEUTR. - 52032922. NR196K - TIBIA OFFSET STEM D18X92MM CEMENTED - 51681838. NR133M - COLUMBUS REV F MC GLID.SURF.T3/3+ 16MM - 51885048.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain

  MAUDE report 12355678 ↗

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