SIGMA 96-2325Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295242086), received between Mar 27, 2022 and Dec 16, 2025 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POLY SWAP AND INSTABILITY. AFFECTED SIDE-UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23815804 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. I & D WITH POLY EXCHANGED WAS PERFORMED. NO SURGICAL DELAY, NO ADVERSE CONSEQUENCES TO THE PATIENT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21548596 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO KNOWN INFECTION. I&D WITH POLY EXCHANGE PERFORMED. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16122825 ↗
• InjuryMar 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED LEFT KNEE. EXTRACTION OF COMPONENTS AND INSERTION OF ANTIBIOTIC SPACER WERE DONE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 13925422 ↗