LCS 9505-03-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295230069), received between Mar 5, 2018 and Mar 5, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMar 5, 2018Break; Loose or Intermittent Connection

  TOTAL KNEE REPLACEMENT ON (B)(6) 2018. THE DOCTOR WAS SETTING UP THE ROD THAT ATTACHES TO THE BLOCK AND REALIZED THAT THE AP BLOCK WOULDN¿T LOCK CORRECTLY. WHEN WE PULLED THE BLOCK APART WE NOTICE THE PLATE AND THE ROD HAD BROKEN AWAY FROM IT SELF, WHICH IS WHY HE COULDN¿T LOCK THE TWO TOGETHER. ACTION TAKEN: OPEN UP ANOTHER TRAY OF INSTRUMENTS TO GET ANOTHER ROD, CALL OPS WHO SENT ANOTHER ROD IN TO REPLACE SO WE HAD ALL THE CORRECT INSTRUMENTS FOR ALL FIVE KNEES ON THAT DAY. NO DELAY TO PROCEDURE. NO AE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7312845 ↗