AS Columbus® REVISION NR565ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046963177331), received between May 20, 2022 and Oct 29, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMay 20, 2022Device 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 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: 400554585 - NR191Z (2916714-2022-00055), 400554586 - NR291Z (2916714-2022-00056), 400554588 - NR565Z (2916714-2022-00058), 400554589 - NR611M (2916714-2022-00059), 400554590 - NR071Z (2916714-2022-00060), 400554591 - NR005Z (2916714-2022-00061), AND 400554592 - NR400Z (2916714-2022-00062).

  Patient problems: Failure of Implant

  MAUDE report 14456858 ↗
• InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP AG THAT A AS COLUMBUS REV FEM.SPACER POST.F5 5MM (PART # NR565Z) 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 (9610612-2022-00145). (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 14456602 ↗
• InjuryMay 20, 2022Device 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 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: 400554585 - NR191Z (2916714-2022-00055), 400554586 - NR291Z (2916714-2022-00056), 400554587 - NR565Z (2916714-2022-00057), 400554589 - NR611M (2916714-2022-00059), 400554590 - NR071Z (2916714-2022-00060), 400554591 - NR005Z (2916714-2022-00061), AND 400554592 - NR400Z (2916714-2022-00062).

  Patient problems: Failure of Implant

  MAUDE report 14456337 ↗
• InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP AG THAT A AS COLUMBUS REV FEM. SPACER POST.F5 5MM (PART # NR565Z) 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) - 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 14456318 ↗