LCS 9505-01-227Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295225324), received between Apr 4, 2019 and Dec 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 16, 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.

• MalfunctionDec 18, 2019Device-Device Incompatibility; Material Twisted/Bent; Mechanical Jam; Device-Device Incompatibility; Material Twisted/Bent; Mechanical Jam

  STEINAMN PIN BENT AND STUCK INSIDE DIVERGENT PIN HOLE OF RIGHT TIBIAL CUTTING BLOCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491040 ↗
• MalfunctionApr 4, 2019Difficult to Remove; Material Deformation; Material Twisted/Bent; Mechanical Jam; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Material Deformation; Material Twisted/Bent; Mechanical Jam; Appropriate Device Problem Term/Code Not Available

  TOTAL KNEE REPLACEMENT: DURING THIS PROCEDURE, A DRILL PIN WAS INSERTED INTO THE BLOCK, TO FIX IT TO THE BONE. IT WAS FOUND TO BE SLIGHTLY BENT, RESULTING IN IT JAMMING IN THE PIN SLOT. IT WAS "COLD WELDED" AND UNABLE TO BE REMOVED. THERE WAS A FIVE MINUTE DELAY TO THE PROCEDURE. ALTERNATE CUTTING BLOCK SOURCED FROM ANOTHER SET. NO AE TO PATIENT.

  Patient problems: Not Applicable

  MAUDE report 8482262 ↗