LCS COMPLETE 1294-24-515Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295024736), received between Oct 23, 2020 and Mar 11, 2025 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN IN THE RIGHT KNEE. PRIMARY SURGERY WAS IN 1994 (DATE, LOCATION, SURGEON FORGOTTEN BY PATIENT). IN 2017 TIBIAL COMPONENT WAS REVISED FOR PAIN TO MBT REVISION TRAY AND LCS VVC POLY BY SURGEON AT HOSPITAL. DOI: (B)(6) 1994. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN. THIS REPORT IS RELATED TO COMPLAINT (B)(4) WHICH CAPTURES THE 2017 REVISION PROCEDURE.

  Patient problems: Pain

  MAUDE report 21576085 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH A PAINFUL KNEE AND SCANS SHOWED THE IMPLANT WAS LOOSE BOTH THE FEMUR AND THE TIBIA AND THE PATIENT WAS EXPERIENCING INSTABILITY. NO INFECTION WAS FOUND. DOI: (B)(6) 2019. DOR:(B)(6) 2022. LEFT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14985781 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN LCS REVISION DUE TO LOOSENING, INFECTION AND FRACTURE (LOOSENING AND FRACTURE ARE UNSPECIFIED). DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10726919 ↗