SIGMA 97-0453Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295250579), received between Nov 15, 2017 and Oct 4, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: UNKNOWN, DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12569051 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FALL AND TORE HER PATELLAR TENDON. THE SURGEON WANTED TO PUT IN A NEWER POLY WHILE HE HAD THE KNEE JOINT EXPOSED WHILE REPAIRING THE PATELLA TENDON. DOI: (B)(6) 2012. DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Fall; No Code Available

  MAUDE report 9831217 ↗
• InjuryMay 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENTS KNEE WAS REVISED DUE TO PAIN IN THE TIBIA SUFFERED AFTER A HARD FALL. THE TIBIAL COMPONENT WAS TAKEN OUT WITH SOME FORCE NEEDS LEAVING CEMENT ON THE TRAY AND IN THE TIBIA. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7529219 ↗
• MalfunctionNov 15, 2017Misconnection; Misconnection

  IT WAS REPORTED THAT THE TIBIAL INSERT IMPLANT WOULD NOT IMPACT INTO TIBIAL TRAY.

  Patient problems: No Information

  MAUDE report 7036221 ↗