LCS 2277-10-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295109495), received between Jun 28, 2018 and Jun 28, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2018Fitting Problem; Fitting Problem

  TKA SURGERY WAS PERFORMED ON (B)(6) 2018. DURING THE SURGERY, THE SURGEON INSTALLED AP CUTTING GUIDE MED AFTER SIZE MEASUREMENT TO THE PATIENT¿S KNEE JOINT, AND DRILLING WAS PERFORMED NORMALLY USING THE IM INITIATOR DRILL FOR THE TIBIA. THEN, WHEN THE SURGEON TRIED TO MOUNT THE ROD TO THE GUIDE, IT WAS REPORTED THAT FEMORAL IM ALIGNMENT ROD COULD NOT BE MOUNTED TO THE CUTTING GUIDE BECAUSE THE HOLES COULD NOT FIT. THE SURGERY WAS COMPLETED BY HAMMERING THE ALIGNMENT ROD INTO THE CUTTING GUIDE WITH A HAMMER. AFTER SURGERY, THE SURGEON CHECKED THE INSTRUMENT¿S CONDITION, AND FOUND THAT IT WAS DIFFICULT TO DETACH IT BY HAND. THERE WAS LESS THAN 30MIN. SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Not Applicable

  MAUDE report 7645085 ↗