SIGMA 1024-56-307Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295501855), received between Jan 4, 2022 and Dec 12, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INSERT DEVICE COULD NOT BE INSERTED. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED, WITHOUT SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789926 ↗
• 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 22009719 ↗
• 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 22004276 ↗
• 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 22004263 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. DOI: UNKNOWN AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 21144376 ↗
• InjuryFeb 1, 2023Naturally Worn; Naturally Worn

  PATIENT IS BEING REVISED FOR KNEE PAIN. THE DOCTOR EXPLANTED THE TIBIAL INSERT AND REMOVED A SMALL PIECE OF CEMENT THAT WAS IN THE JOINT AREA. A NEW SZ 3RM, 7MM INSERT WAS IMPLANTED. THE ORIGINAL DOS (B)(6) 2023. PATIENT RIGHT KNEE. THERE WAS NO DELAY IN SURGERY. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Pain

  MAUDE report 16278054 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  WASH OUT AND INSERT EXCHANGE FOR POSSIBLE INFECTION. LEFT KNEE. ORIGINAL DATE OF SURGERY WAS (B)(6) 2021 BY DR (B)(6) AT (B)(6) MEDICAL CENTER. DOI: (B)(6) 2021. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13154457 ↗