LCS COMPLETE 1294-29-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295025542), received between Aug 30, 2022 and Apr 28, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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.

• InjuryApr 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE SURGEON REVISED LCS FEMORAL COMPONENTS DUE TO COMPONENT LOOSENING. THE SURGEON WAS MADE AWARE THAT ATTUNE REVISION COMPONENTS ARE NOT APPROVED FOR ON LABEL USE WITH AN MBT REVISION TRAY. THE SURGEON FELT IT WAS IN THE BEST INTEREST OF THE PATIENT TO MOVE FORWARD WITH USING ATTUNE REVISION IMPLANTS IN AN OFF-LABEL USE WITH THE EXISTING MBT REVISION TRAY. THERE WAS FEMUR AND PRESSFIT STEM LOOSENING. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21917965 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND ASEPTIC LOOSENING OF FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15322019 ↗