Columbus® REVISION F NR121MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964009433), received between May 7, 2022 and May 18, 2022 — 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.

• InjuryMay 18, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP AG THAT A THAT THERE WAS AN ISSUE WITH NR121M - COLUMBUS REV F MC GLID.SURF.T2/2+ 12MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE IMPLANT LOOSENED POST SURGERY. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 14431749 ↗
• InjuryMay 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A COLUMBUS KNEE IMPLANT (PART # NR121M) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED IN (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PATIENT COMPLAINED THAT HER KNEE FELT LOOSE AND UNSTABLE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, THE SURGEON OPENED THE PATIENT, DEBRINED THE AREA AND IMPLANTED A THICKER POLY AND TIGHTENED THE JOINT SPACE. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY AND IT WAS REPORTED THAT THE SURGERY ON (B)(6) 2022 WAS A REVISION OF A REVISION. THE DATE OF THE PREVIOUS REVISION IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 19, 2022 WHICH REVEALED THAT THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO INTRAOPERATIVE ISSUES AND NO REPORTS OF ANY POST OPERATIVE COMPLICATIONS. THE MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 14319954 ↗