Knee Instruments 11.11024Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040713986), received between Dec 4, 2023 and Dec 4, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2023Fracture; Fracture

  THE SURGEON WANTED TO USE A 30MM/11 TIBIA STEM ON A PATIENT WHO WAS PERFORMING AN LTK, BUT THE EXTENSION SET WAS NOT AVAILABLE DURING SURGERY, SO WE USED THE METAL STEM TRIAL ON THE EFFICIENCY KEEL GRAY HANDLE. THE THREADED PART OF THE TRIAL KEEL S3-4 BROKE INTO THE METAL TRIAL STEM. THE SURGEON WAS NOT ABLE TO REMOVE THE BROKEN PART OF THE KEEL, SO THE SURGERY WAS COMPLETED LEAVING THE TRIAL STEM INSIDE THE PATIENT'S BONE. A NEW KEEL WAS USED AND IT WAS POSSIBLE TO PUNCH IT INTO THE TRIAL BASEPLATE; THE TRIAL STEM WAS PUSHED SLIGHTLY DOWN SO THAT THERE WAS ROOM FOR THE FINAL TIBIA BASEPLATE. A DELAY OF 25 MINUTES OCCURRED ON A TOTAL SURGERY TIME OF ABOUT 1 HOUR AND 25 MINUTES. NO REVISION SURGERY IS CURRENTLY PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18254241 ↗