SIGMA 1024-55-307Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295501558), received between May 16, 2024 and Aug 6, 2025 — 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 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.

• MalfunctionAug 6, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ON AN UNKNOWN DATE; THE PATIENT UNDERWENT AN UKA SURGERY WITH THE IMPLANT IN QUESTION. IN THE SURGERY, THE BEARING COULD NOT BE INSERTED DURING IMPLANTATION. THE SURGEON CAREFULLY CHECKED FOR CEMENT PLACEMENT, BUT THE BEARING COULD NOT BE INSERTED. THE IMPLANT WAS RE-INSERTED SEVERAL TIMES, BUT THERE WERE DOUBTS ABOUT ITS STABILITY, SO THE SIZE WAS CHANGED TO 8MM. AFTER CHANGING THE SIZE, IT BECAME ABOUT 1MM TIGHTER, BUT THE SURGEON DETERMINED THAT THIS WAS NOT A PROBLEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ABOUT 5 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22727978 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SUFFERING FROM INFLAMMATION, BRUSHING, LACK OF MOTION AFTER A PARTIAL KNEE REPLACEMENT. DOI: (B)(6) 2022. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inflammation; Loss of Range of Motion; Pain

  MAUDE report 19331678 ↗