SIGMA 1024-55-308Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295501565), received between Jan 28, 2025 and Feb 5, 2025 — classified as 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 16, 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, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UKA. DURING SURGERY, THE BEARING COULD NOT BE INSERTED. DESPITE CAREFUL CHECK OF CEMENT USE, THE INSERT IN QUESTION COULD NOT BE INSERTED. ALTHOUGH THE SURGEON RE-HAMMERED IT SEVERAL TIMES, THERE WAS CONCERN ABOUT THE FIXATION. THEREFORE, THE SIZE WAS CHANGED TO 7MM. THE SIZE CHANGE MADE IT 1MM LOOSE, THE SURGEON DETERMINED THAT THERE WAS NO PROBLEM. THE SURGICAL TIME WAS EXTENDED APPROXIMATELY 5 MINUTES DUE TO THIS EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313100 ↗
• MalfunctionJan 28, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UKA FOR KNEE OA. DURING THE SURGERY, THE INSERT COULD NOT BE INSERTED. ALTHOUGH THE IMPLANT WAS CLEANSED AND INSPECTED, NO ABNORMALITIES WERE FOUND. THE SURGEON TRIED SEVERAL TIMES; HOWEVER, IT COULD NOT BE INSERTED. THERE WAS AN IMPLANT FOR ANOTHER CASE, AND IT WAS USED FOR THIS PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21253391 ↗