LCS COMPLETE 1294-05-312Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295021957), received between Jan 22, 2020 and Aug 25, 2025 — classified as 2 injuries, 1 malfunction.

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 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY OF LCS KNEE. POLY REPLACEMENT WAS PERFORMED WITH AOX. THERE WAS NO CHANGE IN SIZE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22884352 ↗
• MalfunctionJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RUPTURE OF THE FEMORAL COMPONENT WITH FEMORAL BONE EROSION AND FRACTURE OF THE MEDIAL AND LATERAL CORTEX. REVISION SURGERY NECESSARY. SURGEON REFERS THAT THE PATIENT HAD SEVERE HYPOKINETIC SYNDROME DUE TO PROGRESSIVE INABILITY TO WALK.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14827902 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT NEEDS TO FILE A COMPLAINT OVER KNEE REVISION SURGERY. SHE HAD TO HAVE THIS YEAR DUE TO FAILURE LESS THAN 5 YEARS FROM THE ORIGINAL SURGERY.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9616390 ↗