LCS 1278-24-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295020400), received between Oct 31, 2018 and Jul 11, 2022 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2022Naturally Worn; Naturally Worn

  SURGEON REPORTED TO BFARM: "REVISION OF KNEE-TEP RIGHT SIDE ON (B)(6) 2022 AFTER APPROXIMATELY 20 YEARS - FRACTURE OF THE FEMORAL LCS CLASSIC SHIELD. MEDIAL FEMORAL CONDYLE SHOWS A TRANSVERSE IMPLANT FRACTURE (IMAGES ARE AVAILABLE UPON REQUEST). PE INLAY CORRESPONDING (FULL-LAYER WEAR). THE IMPLANT WAS SCRAPPED AT THE PATIENT'S REQUEST." DOI: (B)(6) 2001. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 14977228 ↗
• MalfunctionJun 25, 2020Naturally Worn; Naturally Worn

  THE MENICSAL BEARING IS WORN OUT CAUSING INSTABILITY IN THE PATIENT KNEE.

  Patient problems: No Code Available

  MAUDE report 10197389 ↗
• InjuryOct 31, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 8024140 ↗