LCS COMPLETE 1294-09-570Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295022602), received between Aug 22, 2018 and Jun 14, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. PLEASE VERIFY IF THERE WAS A CONFIRMED INFECTION? 1) THERE WAS NO MICROBIAL CONFIRMATION IN EITHER THE ONE WEEK OR TWO WEEK CULTURES, HOWEVER DR (B)(6) STATED TO ME THAT HIS CONCLUSION WAS INFECTION DUE TO OSTEOLYSIS OF THE SURROUNDING TISSUE. B. STATED IN THE EVENT, "REASON FOR REVISION: TIBIAL LOOSENING." PLEASE CONFIRM WHAT INTERFACE WAS LOOSE. 2) THE BONE-CEMENT INTERFACE WAS LOOSE. C. WAS LOOSENING DUE TO INFECTION? 3) UNKNOWN, BUT THE LOOSENING WAS PRESUMED TO BE DUE TO INFECTION.

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

  MAUDE report 11994749 ↗
• InjuryAug 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL PATELLA.

  Patient problems: Not Applicable; Pain

  MAUDE report 7806447 ↗