Advance KTSLFM31Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684KTSLFM311), received between Jul 3, 2019 and Dec 23, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2019Unstable; Naturally Worn; Unstable; Naturally Worn

  ALLEGEDLY, INSTABILITY. THE AREA AROUND THE IMPLANTS WAS ALL BLACK, 'POSSIBLE METALLOSIS" CULTURES TAKEN: LATERAL CONDYLE POSTERIORLY HAD SIGNIFICANT WEAR ON POLY, FEMUR WORE THROUGH POLY AND WAS METAL ON METAL W/ BASE PLATE.

  Patient problems: No Information

  MAUDE report 9512429 ↗
• InjuryJul 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY TIBIAL PAIN IS WHAT THE PATIENT WAS EXPERIENCING AND REVISED DUE TO. THE POLY WAS REMOVED ALONG WITH THE TIB BASE AND KEEL. A NEW TIB BASE WAS IMPLANTED ALONG WITH A 2.5 MM AUGMENTS AND A POLY. (RIGHT)

  Patient problems: Pain

  MAUDE report 8759495 ↗