LCS COMPLETE 1294-01-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295021544), received between Sep 20, 2021 and Sep 10, 2025 — 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 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.

• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA TKA FOR OA ON THE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IN (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY AND THE TIBIAL TRAY WAS REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IN (B)(6) 2025, THE PATIENT WAS IN PAIN AND WAS EXAMINED, WHICH REVEALED A SUSPECTED INFECTION. IMPLANT REMOVAL IS PLANNED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23015629 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A SURGERY TREATING THE KNEE JOINT. ON (B)(6) 2021, BECAUSE OF INFECTION, ALL IMPLANTS WERE REMOVED, AND A CEMENT MOLD WAS INSERTED. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE PATIENT IS SCHEDULED TO UNDERGO REVISION SURGERY IN 6 WEEKS. DOI: (B)(6) 2019, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12497093 ↗