LCS COMPLETE 1294-41-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295026105), received between Mar 4, 2020 and Aug 28, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).

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.

• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE ORIGINAL SURGERY THE PATELLA WAS LEFT NATIVE. FOR THIS REVISION THE PATELLA WAS RESURFACED WITH A SIGMA OVAL DOME PATELLA 35MM.

  Patient problems: Osteolysis; Pain

  MAUDE report 20088074 ↗
• InjuryAug 9, 2023Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED AGAIN IN 2017 WITH PAIN AND BONE SCANS SUGGESTING LOOSENING. REVISED THE ENTIRE CONSTRUCT SLEEVES AND STEMS. DOI: UNKNOWN. DOE: (B)(6) 2017. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 17486949 ↗
• InjuryMar 4, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  LOOSE FEMORAL COMPONENT, SURGEON THOUGHT THAT THIS HAD BEEN REVISED DUE TO A LARGE BONE CYST BEHIND THE IMPLANT ON THE MEDIAL ASPECT OF THE KNEE. UPON REMOVAL THE SURGEON FELT THAT THERE WAS DE-BONDING OF THE CEMENT AND IMPLANT. FEMUR AND INSERT WERE REVISED TO AND LCS MODULAR FEMUR WITH DISTAL AND POSTERIOR AUGMENTS MEDIALLY AND LATERALLY, AND A CEMENTED STEM. UNKNOWN JRN: 1 X PS FEMUR SZ 7; 1 X FB INSERT SZ 7/1; 1 X FB S+ TRAY SZ 5.

  Patient problems: Cyst(s); No Code Available

  MAUDE report 9788385 ↗