SIGMA 96-2358Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295242451), received between Feb 17, 2021 and Jun 16, 2023 — classified as 6 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2010. DATE OF REVISION: (B)(6) 2023. (LEFT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 17142580 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION IN KNEE. POLY WAS SWAPPED FOR SAME SIZE INSERT AND JOINT WAS WASHED OUT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17106050 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL & TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. REMOVAL OF ALL IMPLANTS DUE TO CEMENT COULDN'T SEE MOST NUMBERS. ONLY ABLE TO OBTAIN THE NUMBERS FROM FEMORAL STEM, TC3 RP INSERT AND THE THICK TRAY. ALL OTHER PARTS WERE COVERED BY CEMENT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12517244 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT THE PATIENT WAS REVISED IN 2018 WITH A THICKER POLY (THICKEST AVAILABLE). PATIENT COMPLAINING OF PAIN IN KNEE AND NOT FEELING STABLE. SURGEON OPTED FOR SURGERY TO REVISE TIBIA, REMOVING TRAY STEM AND SLEEVE. REPLACED WITH A THICK TRAY, BIGGER SLEEVE, STEM AND NEW POLY TO GAIN BETTER BALANCE. SURGERY WAS SUCCESSFUL.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12338567 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL IMPLANT EXPLANTED, CONVERT TO ANTIBIOTIC SPACER DUE TO INFECTION. POLY INSERT CHANGED ON (B)(6) 2019 FROM PREVIOUS INFECTION. DOI: (B)(6) 2019, ALL EXPLANTED PRODUCTS. DOI: (B)(6) 2019, TIBIAL INSERT. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 11917924 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO RT TKA INFECTION. DOI: (B)(6) 2018. DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11337610 ↗