LCS COMPLETE 1294-16-515Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295023265), received between Sep 15, 2021 and Aug 24, 2022 — classified as 2 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 18, 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.

• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND SOME FEELINGS OF MECHANICAL FAILURE DUE TO PRIOR TKA. UPON SURGERY, THE SURGEON FOUND TRACKING ABNORMALLY AND KNEE BALANCE LOOSE IN FLEXION AND EXTENSION. PATELLA AND TIBIAL POLY BEARING WERE REPLACED. NO INFORMATION/PAPERWORK AVAILABLE. THE PATELLA WAS DAMAGED UPON REMOVAL. THE CEMENT MANUFACTURER WAS NOT INDICATED. NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2012; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15283565 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED IN THE LEFT KNEE DUE TO ARTHROFIBROSIS. REMOVED FEMUR, INSERT AND TRAY. ORIGINAL DOS IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 12473742 ↗