SIGMA 1024-53-408Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295002598), received between May 18, 2021 and Feb 5, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• MalfunctionFeb 5, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING KNEE SURGERY THE PE INLAY COULD NOT BE ASSEMBLED TO THE TIBIA. AN ALTERNATE INLAY WAS AVAILABLE, AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY OR ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270415 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. SURGEON REVISED PATIENT TO A TOTAL KNEE REPLACEMENT. ALL UNI IMPLANTS WERE EXTRACTED. THERE WAS NO LOOSENING OF THE UNI IMPLANTS. ONCE ALL IMPLANTS WERE EXTRACTED, PROCEEDED WITH TOTAL KNEE REPLACEMENT. IMPLANTED A CRS FEMUR AND ATTUNE RP REVISION TRAY WITH A 5MM RP STABILIZE INSERT. THERE WAS NO DELAY IN SURGERY. THERE WAS NO INJURY TO THE PATIENT. THIS WAS THE PATIENT'S LEFT KNEE. ORIGINAL DATE OF SURGERY WAS (B)(6) 2015. ADDITIONAL INFORMATION RECEIVED STATED THAT THIS WAS DUE TO NATURAL PROGRESSION AND AN ACL TEAR.

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

  MAUDE report 11840902 ↗