ADVANCE® KFTCNN3RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684KFTCNN3R1), received between Apr 13, 2021 and Mar 12, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Improper or Incorrect Procedure or Method; Packaging Problem; Improper or Incorrect Procedure or Method; Packaging Problem

  ALLEGEDLY, WE WERE IN A RTR AND AT THE TIME OF PASSING THE FEMORAL COMPONENTS THESE GAVE US IN FEMUR 3 RIGHT STATURE AND TIBIA 3 STANDARD. THE FEMORAL COMPONENT IS RECTIFIED AND PASSED, WE CEMENTED IT AND AT THE TIME OF PLACING IT IN THE KNEE WE REALIZE THAT THIS HAD SOMETHING STRANGE AND THAT WE DID NOT HUNT, WITH THE SURGEON OBSERVED THAT THIS COMPONENT WAS NOT 3 STATURE RIGHT IF NOT LEFT, TO BUY IT WITH THE TEST COMPONENTS WE REALIZE THAT IT IS 2 STANDARD LEFT. WE RECTIFY THE BOX AND WE REALIZE THAT IN THIS INDEED IF IT WAS RIGHT THE NAME OF 3 STATURE RIGHT, BUT THE FACTORY IMPLANT WAS WRONGLY PACKAGED. THE PATIENT WAS FITTED WITH A STANDARD RIGHT 3 COMPONENT AND IT WAS A BIT TOO BIG FOR HER, WHICH MAY CAUSE LOOSENING OF THE PROSTHESIS IN THE FUTURE.

  Patient problems: Insufficient Information

  MAUDE report 21588223 ↗
• InjuryJun 14, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR/ ASEPTIC LOOSENING TIBIA REVISION NJR NUMBER: (B)(4), SIDE: R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. MHRA REFERENCE NO: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11992510 ↗
• InjuryApr 13, 2021Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. (B)(4). SIDE: R PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING (B)(4)

  Patient problems: Bone Fracture(s)

  MAUDE report 11658150 ↗