SIGMA 97-0440Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295250487), received between Jul 9, 2018 and Feb 9, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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.

• MalfunctionFeb 9, 2021Expiration Date Error; Expiration Date Error

  EXPIRED ITEM IMPLANTED IN PATIENT (B)(6) 2021. ITEM EXPIRED (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11301458 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FLEXION CONTRACTURE. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10623419 ↗
• InjuryJul 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE. PATIENT WAS BROUGHT TO SURGERY FOR REVISION. THE FEMORAL COMPONENT WAS REMOVED AND REPLACED WITH A POSTERIOR STABILIZED IMPLANT. DOI: (B)(6) 2013; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7669577 ↗