Columbus® REVISION F NR633MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964010002), received between Jul 6, 2020 and Jul 6, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryJul 6, 2020Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT COLUMBUS REV F HC GLID.SURF.T3/3+ 16MM. SPECIFICALLY, IT WAS REPORTED THAT AN AESCULAP COLUMBUS REVISION KNEE WAS REVISED DUE TO INSTABILITY 1 YEAR AND 4 MONTHS POSTOPERATIVELY. THE ORIGINAL SURGERY DATE WAS (B)(6) 2019. THE SURGEON REMOVED THE OLD INSERT AND IMPLANTED A NEW INSERT OF A LARGER THICKNESS; THE REPLACEMENT WAS ALSO A COLUMBUS COMPONENT. NO COMPONENTS WERE NOTED AS LOOSE. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information; Joint Disorder

  MAUDE report 10233622 ↗
• InjuryJul 6, 2020Loosening of Implant Not Related to Bone-Ingrowth

  NO UPDATES.

  Patient problems: No Code Available

  MAUDE report 10233618 ↗