AS Columbus® REVISION NR475ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963177256), received between Oct 29, 2024 and Oct 29, 2024 — 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.

• 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 ↗