LCS COMPLETE 1294-16-410Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295023173), received between Jul 17, 2019 and May 16, 2023 — classified as 3 injuries.

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

• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WERE NO BROKEN PIECES. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16940505 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT NONE OF THE IMPLANTS WERE REVISED. THE PATIENTS PATELLA WAS RESURFACED AND THE ECTOPIC BONE REMOVED. NONE OF THE KNEE COMPONENTS LISTED REQUIRED REVISION AND WERE ALL LEFT IN SITU. AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

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

  MAUDE report 12041129 ↗
• InjuryJul 17, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND WEAR. DOI: UNKNOWN; DOR: (B)(6) 2019; UNKNOWN KNEE.

  Patient problems: No Code Available

  MAUDE report 8798488 ↗