LCS 1278-14-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295020264), received between Nov 30, 2022 and Dec 9, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON WILL BE REVISING BOTH LEFT AND RIGHT KNEES AND EXCHANGING THE POLYETHYLENE INSERTS WHEN CUSTOM REPLACEMENTS BECOME AVAILABLE. THE IMPLANTS HAVE RUN THEIR COURSE - 29 YEARS. DOI: (B)(6) 1995: PATIENT RECEIVED A RIGHT LCS TKA TO TREAT JUVENILE RA AND OA.

  Patient problems: Insufficient Information

  MAUDE report 20880170 ↗
• MalfunctionNov 30, 2022Naturally Worn; Naturally Worn

  A-8351333 - DEC 04 2022 ADDITIONAL INFORMATION RECEIVED. A. WAS THE VARUS DEFORMITY A PREEXISTING CONDITION, OR WAS THE DEFORMITY RELATED TO THE TKA? RELATED TO THE TKA. IT WAS REPORTED THAT THE WEAR OF THE INSERT IS PROGRESSING AND THE VARUS DEFORMATION IS PROGRESSING.

  Patient problems: Insufficient Information

  MAUDE report 15887616 ↗