SIGMA 1024-56-308Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295501862), received between Dec 21, 2023 and Mar 19, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR DECIDED TO PULL POLY ON PARTIAL KNEE REPLACEMENT BECAUSE OF SUSPECTED INFECTION. REPLACED WITH SAME SIZE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24637869 ↗
• MalfunctionMay 13, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLYS WOULD NOT SEAT INTO FINAL IMPLANT. THERE WAS A DELAY OF APPROXIMATELY TEN MINUTES. COULD NOT VERIFY THE POLYETHYLENE WAS SEATED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22009721 ↗
• MalfunctionMay 12, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY IMPLANT WOULD NOT FULLY SEAT WHEN IMPLANTED DURING UKA PROCEDURE. THEY TRIED A DIFFERENT IMPLANT AND IT WOULDN'T SEAT. THEY CLEARED OUT ADDITIONAL BONE AND TRIED AGAIN BUT IT STILL WOULDN'T SEAT. THEY TRIED AN IMPLANT THE NEXT SIZE UP BUT IT WOULDN'T SIT EITHER. THE DOCTOR DECIDED THAT THE BEST CLINICAL OUTCOME WOULD BE TO PUT THE SMALLER IMPLANT IN AND USE THE PATIENTS WEIGHT TO FULLY SEAT THE IMPLANT. THE FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED WITHOUT PROBLEM. THE ROBOT APPEARED TO PERFORM AS EXPECTED. THE CASE HAD ISSUES WITH SEATING THE POLY IMPLANT AFTER THE ROBOTIC STEPS WERE COMPLETED. ALL UNI IMPLANTS ARE CEMENTED AS PLANNED. THERE WAS A 40 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004278 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) AND POLY SWAP WAS PERFORMED. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18372504 ↗