SIGMA 86-6469Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295217183), received between Oct 18, 2017 and Jan 26, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. IMPLANTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6). AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16246208 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. STATIC SPACES USED. NO OTHER INFORMATION WAS AVAILABLE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9718950 ↗
• MalfunctionOct 18, 2017Product Quality Problem; Defective Device; Material Integrity Problem; Product Quality Problem; Defective Device; Material Integrity Problem

  IT WAS REPORTED THAT THE STEM WAS DAMAGED ALONG THE THREADED SECTION.

  Patient problems: No Information

  MAUDE report 6957525 ↗