Columbus® REVISION F NR074KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963338145), received between Apr 29, 2021 and Apr 29, 2021 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryApr 29, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NR049Z - AS COLUMBUS TIB.HEMI-SP.T2/2+ 10MM RM/LLVIA INFORMATION RECEIVED FROM MW5099720. ACCORDING TO THE COMPLAINT DESCRIPTION, AN ADVERSE EVENT OCCURRED INVOLVING HER AESCULAP LEFT KNEE IMPLANT. PATIENT STATED THAT SHE HAD THIS KNEE IMPLANTED IN 2018 AND NOTICED IN 2019 THAT SHE BEGAN HAVING SEVERE PAIN. PATIENT STATED THAT HER DOCTOR DID A BONE SCAN WHICH SHOWED THE IMPLANT HAS LIFTED AND BECOME LOOSE. PATIENT STATED HER DOCTOR TOLD HER THE IMPLANT WILL NEED TO COME OUT. THERE WAS A PERMANENT IMPAIRMENT. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00342 (B)(4)+ NR475Z.

  Patient problems: Failure of Implant

  MAUDE report 11749470 ↗