SIGMA 96-2337Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295242185), received between Oct 19, 2017 and Mar 6, 2026 — classified as 11 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO A FALL, RESULTING IN A TORN VMO. THE SURGEON REPLACED THE INSERT WITH A LARGER POLY. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 24532704 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. WASHOUT WAS DONE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22116459 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THEREFORE, THE POLY WAS SWAPPED FOR IDENTICAL REPLACEMENT AND WOUND WAS IRRIGATED COPIOUSLY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2018. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20156706 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMUR COMPONENT WERE LOOSE DUE TO PRE-PATELLAR BURSA. THE FEMUR AND POLY WERE REPLACED.

  Patient problems: Inflammation

  MAUDE report 19461002 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INFECTION WAS CONFIRMED. AS THIS WAS A REVISION PROCEDURE, THERE WAS NO SURGICAL DELAY. THE PRODUCT SPECIALIST THINKS IT WAS A COMPETITORS CEMENT THAT WAS USED. ALL KNEE COMPONENTS WERE REMOVED, AND A TEMPORARY CEMENT SPACER WAS INSERTED.

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

  MAUDE report 12089646 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY EXCHANGE WAS DONE. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 11229687 ↗
• InjuryJul 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING KNEE PAIN FROM POSSIBLE INFECTION, BUT AFTER GOING INTO THE JOINT PATIENT WAS NOT INFECTED, THE SURGEON JUST DID A WASH OUT AND EXCHANGE OF THE POLY. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8771108 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8752697 ↗
• MalfunctionApr 4, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE INNER PORTION OF THE PACKAGE WAS DAMAGED. DISCOVERED UPON OPENING. DOE: (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483653 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D AND POLY SWAP WAS PERFORMED. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8483600 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7074338 ↗
• InjuryOct 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6962011 ↗