Columbus® REVISION F NR124MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964009464), received between Jan 13, 2023 and Oct 29, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 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 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 ↗