SIGMA 97-0443Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295250517), received between Oct 26, 2018 and Mar 1, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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.

• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN; DOR: (B)(6) 2019; AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8382286 ↗
• MalfunctionNov 9, 2018Fitting Problem; Fitting Problem

  WHEN THE INSERT SHOULD BE PLACED, THE INSERT DID NOT GET FIXED IN I2LOCKING PART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054576 ↗
• InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8010020 ↗