LCS COMPLETE 1294-01-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295021537), received between May 7, 2018 and Feb 3, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT PRIMARY SURGERY WITH THE PRODUCT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2026, THE PATIENT WAS FOUND TO HAVE A CONFIRMED INFECTION. ON (B)(6) 2026, THE HOSPITAL ELECTED TO REPLACE THE LINER AND FEMORAL HEAD, WHILE THE STEM AND CUP REMAINED IN SITU DUE TO THE ABSENCE OF LOOSENESS. THE REPLACEMENT PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY OR COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 24248021 ↗
• InjuryOct 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PRIMARY SURGERY WAS PERFORMED ABOUT 15 YEARS AGO VIA TKA WITH LCS IMPLANTS. IT WAS REPORTED THAT THE PATIENT HAD A PAIN AND LOOSENING OF THE FEMORAL COMPONENT WAS FOUND IN (B)(6) 2020. THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020. THE SURGEON EXCHANGED THE FEMORAL COMPONENT AND INSERT.

  Patient problems: No Code Available; Pain

  MAUDE report 10656369 ↗
• InjuryMay 7, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  PATIENT HAD KNEE REVISION FOR ASEPTIC LOOSENING OF ALL COMPONENTS. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7490492 ↗