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AS Columbus® REVISION NR464ZRecalls & reported problems

Aesculap AG · AS COLUMBUS REV FEM.SPACER DIST.F4 5MM · Class 2 · Implant

All models of AS Columbus REVISION (13)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963177164), received between Nov 9, 2021 and Nov 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

    IT WAS REPORTED TO AESCULAP AG THAT AN AS COLUMBUS REV FEM.SPACER DIST.F4 5MM (PART # NR464Z) WAS TO BE IMPLANTED DURING A LEFT KNEE REVISION PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, BOTH THE OUTER AND INNER PACKAGING OF THE AS COLUMBUS REV F FEMUR CEMENTED F4L (PART # NR004Z) (REF. MDR ID 9610612-2021-00656) HAD BEEN CUT THROUGH. SLITS WERE IDENTIFIED TOWARD THE BOTTOM OF THE PACKAGING. REPORTEDLY, A TEN (10) TO (15) MINUTE PROCEDURAL DELAY OCCURRED AND THE SIZE OF THE DEVICE HAS TO BE INCREASED FROM FOUR (4) TO FIVE (5). ADDITIONALLY, THE AS COLUMBUS REV FEM.SPACER DIST.F4 5MM (PART # NR464Z) HAD TO BE SWAPPED OUT AS A RESULT OF HAVING TO MOVE TO THE NEXT LARGER DEVICE SIZE. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A MODIFIED SURGICAL PROCEDURE WAS NECESSARY. THE ADVERSE EVENT IS FILED UNDER (B)(4) REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS 9610612-2021-00656 ((B)(4) NR004Z). 9610612-2021-00708 ((B)(4) NR464Z).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12780027 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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