LCS COMPLETE 1294-27-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295025382), received between Jun 19, 2018 and Apr 28, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 5 most recent of 5 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 21917961 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OF LCS IMPLANTS WAS PERFORMED ON (B)(6) 2025 DUE TO PATIENT INFECTION. THERE WAS NO SURGICAL DELAY. NO CEMENT WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 21561127 ↗
• InjuryMay 8, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED DUE TO POSSIBLE INFECTION AND LOOSENING OF THE FEMORAL AUGMENTS AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 10038980 ↗
• InjuryMay 8, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED DUE TO POSSIBLE INFECTION AND LOOSENING OF THE FEMORAL AUGMENTS AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 10038977 ↗
• InjuryJun 19, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION TOTAL KNEE REPLACEMENT, DR. (B)(6), (B)(6) 2018. REVISION OF REVISION LCS TKR DUE TO FEMORAL LOOSENING, TIBIA REMAINED INSTITU. PATIENT INITIALS: (B)(6), MALE AGED (B)(6). UNKNOWN JRN: LCS COMP RP LARGE 12.5MM REVISION; UNKNOWN JRN: LARGE FEMUR LEFT REVISION; UNKNOWN: JRN: 115 X 20 MM UNCEMENTED TIBIAL STEM.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7613072 ↗