Columbus® REVISION F NR135MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964009297), received between Aug 20, 2021 and Aug 20, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryAug 20, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NR135M - COLUMBUS REV F MC GLID.SURF.T3/3+ 20MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WAS A REVISION SURGERY FOR POLY SWAP 2 MONTHS POST SURGERY. PATIENT HAD RETURNED TO FULL ACTIVITY AND DISLOCATED THE TKA WITH THE FEMUR JUMPING THE PS POST. THE SURGEON REMOVED THE MC POLY AND REPLACED IT WITH A HC POLY OF THE SAME THICKNESS. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NR410Z - AS FEMUR EXTENS.STEM 5° D20X117 CEM.LESS - LOT 52574825. NR400Z - AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR. - LOT 52606425. NR465Z - AS COLUMBUS REV FEM.SPACER DIST.F5 5MM - LOT 52535726. NR076Z - AS COLUMBUS REV F TIB.OFFSET CEMENT.T3+ - LOT 52464853C. NR177Z - AS TIBIA OFFSET STEM D17X92 CEMENTLESS - LOT 52591752. NR565Z - AS COLUMBUS REV FEM.SPACER POST.F5 5MM - LOT 52533878. NR015Z - AS COLUMBUS REV F FEMUR CEMENTED F5R - LOT 52571435.

  Patient problems: Failure of Implant

  MAUDE report 12350186 ↗
• InjuryAug 20, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  INVOLVED COMPONENTS: NR410Z - AS FEMUR EXTENS.STEM 5° D20X117 CEM.LESS - LOT 52574825, NR400Z - AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR. - LOT 52606425, NR465Z - AS COLUMBUS REV FEM.SPACER DIST.F5 5MM - LOT 52535726, NR076Z - AS COLUMBUS REV F TIB.OFFSET CEMENT.T3+ - LOT 52464853C, NR177Z - AS TIBIA OFFSET STEM D17X92 CEMENTLESS - LOT 52591752, NR565Z - AS COLUMBUS REV FEM.SPACER POST.F5 5MM - LOT 52533878, NR015Z - AS COLUMBUS REV F FEMUR CEMENTED F5R - LOT 52571435.

  Patient problems: Failure of Implant

  MAUDE report 12350184 ↗