ADVANCE® KFTCPC4LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684KFTCPC4L1), received between Aug 22, 2019 and Mar 8, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2022Break; Break

  ALLEGEDLY, THE PRODUCT WAS REVISED BECAUSE IS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 13690516 ↗
• InjuryMar 17, 2020Unstable; Unstable

  ALLEGEDLY, LOOKS LIKE THE TIBIAL BASE PLATE IS LOOSENING , PATELLA WAS SPINNING AND FEMUR COULD NOT BALANCE IN FLEXION AND EXTENSION SO FEMUR HAD TO GO ADDITIONAL INFORMATION: LEFT KNEE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9844659 ↗
• InjuryDec 24, 2019Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAIN AND XRAYS THAT SHOWED LOOSENING OF IMPLANTS. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 9515972 ↗
• InjuryAug 22, 2019Loose or Intermittent Connection; Failure to Osseointegrate; Loss of Osseointegration; Loose or Intermittent Connection; Failure to Osseointegrate; Loss of Osseointegration

  ALLEGEDLY THE LEFT KNEE ALWAYS HAD PAIN, FAILURE TO INTEGRATE ASEPTIC LOOSENING. DR. (B)(6) REMOVED THE FEMUR, TIBIA, POLY AND KEEL AND PATELLA WAS KEPT.

  Patient problems: Pain

  MAUDE report 8922873 ↗