LCS COMPLETE POROCOAT 1294-03-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295021728), received between Nov 3, 2017 and Jun 14, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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

  MAUDE report 11994841 ↗
• InjuryNov 3, 2017Malposition of Device; Malposition of Device

  DER STATES THAT THERE WAS MALALIGNMENT OF LCS FEMORAL COMPONENT LEADING TO LIMITED ROM IN THE KNEE. IT WAS REPORTED THAT THE SURGEON EXPLANTED FEMUR AND POLY AND REVISING WITH SIGMA FEMUR.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 6998672 ↗