Advance KTSLFM40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684KTSLFM401), received between Aug 22, 2019 and Mar 17, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2020Loss of Osseointegration; Loss of Osseointegration

  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 Information

  MAUDE report 9842791 ↗
• 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 8922871 ↗