LCS SIGMA 1294-31-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295025634), received between Feb 23, 2021 and Jan 30, 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.

• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21275375 ↗
• InjuryFeb 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN, BONE LOSS AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. A COMPETITOR CEMENT WAS USED. IT WAS REPORTED THAT THE FEMUR CAME OFF FIARLY EASY, THE CEMENT HAD DEBONDED FROM THE FEMUR. THERE WAS A SIGNIFICANT AMOUNT OF BONE LOSS. IT WAS ALSO REPORTED THAT THE OVAL DOME PATELLA WAS REPLACED DUE TO WEAR. THE TRAY WAS REMOVED AND THE STEM WAS WELL FIXED. THE IMPLANT WAS A SIGMA RP/PS FLEX KNEE. NO SURGICAL DELAY. DOI: 10-15 YEARS AGO, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11365881 ↗