SIGMA 97-0431Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295250432), received between May 17, 2018 and Sep 6, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT'S KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S PRIMARY SIGMA FIXED BEARING CRUCIATE RETAINING COMPONENTS (INSERT, TIBIAL TRAY, AND FEMUR) WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20157556 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POLY EXCHANGE DUE TO INFECTION. NO NEGATIVE COMMENTS WERE DIRECTED TOWARDS DEPUY. NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14976448 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO DELAY IN SURGERY. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12288127 ↗
• InjuryOct 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 8009581 ↗
• InjuryMay 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND POSSIBLE LOOSENING OF TIBIA ON BONE SCAN. TK-SIGMA CR CEMENTED. COMPONENTS FOUND TO BE WELL FIXED - EXTENSIVE SYNOVECTOMY. UPSIZE POLY TO A 12.5 FROM A 10. STABLE AND GOOD ROM DOI: 2014; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7521922 ↗