LCS COMPLETE AOX 1294-18-412Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295024163), received between Dec 7, 2020 and Sep 16, 2021 — 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 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.

• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRIMARY LEFT IMPLANTS ON (B)(6) 2020. SHE HAD AN I&D AND REPLACEMENT OF POLY ON (B)(6) AND (B)(6) 2020 ((B)(4)). THIS PATIENT IS VERY SICK WITH MULTIPLE COMORBIDITIES. SHE HAD AN ABSCESS ON THE LEFT KNEE SURGICAL SITE. THERE WAS NOTICEABLE ASEPTIC LOOSENING OF THE FEMORAL AND PATELLA COMPONENTS. ALL IMPLANTS WERE REMOVED WITH NO PLAN TO REIMPLANT. SURGEON PERFORMED AN END-STAGE ARTHRODESIS. HER RIGHT KNEE WAS PERFORMED YEARS AGO AND SEEMS TO BE UNAFFECTED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 12480936 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INFECTED WOUND SITE AFTER A TKA ON (B)(6) 2020 .THE INFECTION WAS PAST THE DERMAL LAYER AND SURGEON WAS CONCERNED IT MAY HAVE SPREAD TO THE JOINT SPACE. SURGEON REMOVED POLY AND PERFORMED AN I & D AND PLACED IN A NEW POLY.

  Patient problems: Insufficient Information

  MAUDE report 10958657 ↗