Columbus® REVISION F NR611MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964009839), received between May 20, 2022 and May 20, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗