SIGMA 1024-53-208Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295002499), received between Oct 25, 2021 and Feb 17, 2022 — classified as 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 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.

• MalfunctionFeb 17, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SIGMA PARTIAL KNEE INSERT DOESN'T FIT WITH TIBIA TRAY. DOCTOR CANNOT INSERTED TO TIBIA. THERE WAS A TEN MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 13548525 ↗
• MalfunctionFeb 17, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SIGMA PARTIAL KNEE INSERT DOESN'T FIT WITH TIBIA TRAY. DOCTOR CANNOT INSERTED TO TIBIA. THERE WAS A TEN MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 13548524 ↗
• MalfunctionFeb 17, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SIGMA PARTIAL KNEE INSERT DOESN'T FIT WITH TIBIA TRAY. DOCTOR CANNOT INSERTED TO TIBIA. THERE WAS A TEN MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 13548522 ↗
• MalfunctionOct 25, 2021Difficult to Insert; Difficult to Insert

  COULD NOT LOCK THE INSERT. IT WAS REPORTED THAT DURING THE SURGERY OF SINGLE CONDYLAR REPLACEMENT, THE INSERT COULD NOT MATCH WITH PLATEAU(AS THE VIDEO SHOWS). ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689341 ↗