LCS COMPLETE AOX 1294-17-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295023739), received between Jun 12, 2019 and Jun 12, 2019 — classified as 1 injury.

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

• InjuryJun 12, 2019Naturally Worn; Naturally Worn

  THERE WAS A LOOSE TIBIA WITH A LCS RPS PRIMARY KNEE. THE MEDIAL PROX. TIBIAL BONE GAVE WAY UNDER THE TRAY CAUSING IT TO COLLAPSE. THE FEMUR LOOKED FINE BUT WAS REMOVED DUE TO LIGAMENT INSTABILITY. THE POLY SHOWED SOME PITTING BUT IT HAD BEEN IN ABOUT 10 YEARS. THE FEMUR HAD SOME LYSIS BEHIND THE FEMUR.

  Patient problems: Injury; No Code Available; Osteolysis

  MAUDE report 8692804 ↗