LCS COMPLETE 1294-28-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295025450), received between May 21, 2019 and Aug 20, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.

• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FEMORAL PAIN AND SLIGHT INSTABILITY. THE SURGEON REMOVED THE FEMORAL PARTS AND PUT IN A TC3 FEMUR AND INSERT. HE USED A COMPETITOR FEMORAL SLEEVE WITH OUR FEMUR AND STEM IMPLANTS. THE SALES REP ADVISED AGAINST THIS BUT THE SURGEON DECIDED TO DO IT ANYWAY. DOI: (B)(6) 2017. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8910652 ↗
• InjuryMay 21, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AFTER UNPACKING A STERILE LCS VVC FEMUR, WE DISCOVERED AN UNKNOWN CONTAMINATION ON THE PROSTHESIS. IT WAS HARD AND DRY WHEN TOUCHING IT, SO DEFINITIVELY NO TISSUES FROM THE SURGERY. AS WE ONLY HAD THIS SIZE OF PROSTHESIS ONCE IN THE HOSPITAL, THE DOCTOR CAREFULLY CLEANED THIS CONTAMINATION MANUALLY AND RINSED THE PROSTHESIS WITH LAVASEPT BEFORE IMPLANTING IT.

  Patient problems: Not Applicable

  MAUDE report 8627981 ↗