NA 1294-56-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295026747), received between May 20, 2019 and Dec 8, 2020 — classified as 5 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 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.

• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO THE TIBIA MID FLEXION INSTABILITY AND KNEE PAIN. THE TIBIA, THE TWO 5MM AUGMENTS AND THE POLYETHYLENE WERE EXPLANTED AND REVISED TO HELP THE ISSUE. THE COMPONENT WAS NOT LOOSE AT ALL. THE POLY HAD NO WEAR. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 10968658 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO THE TIBIA MID FLEXION INSTABILITY AND KNEE PAIN. THE TIBIA, THE TWO 5MM AUGMENTS AND THE POLYETHYLENE WERE EXPLANTED AND REVISED TO HELP THE ISSUE. THE COMPONENT WAS NOT LOOSE AT ALL. THE POLY HAD NO WEAR. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 10968639 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP, CHRONIC INFECTION, POSITIVE CULTURE FOR STAPHYLOCOCCUS CAPRAE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DOI: (B)(6) 2017. DOE: (B)(6) 2019 (LEFT KNEE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9483906 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON HAD TO REVISE AN SIGMA TC3 AND MBT REVISION TIBIA DUE TO PATIENT DISCOMFORT AND INSTABILITY. SURGEON REMOVED ALL EXISTING IMPLANTS AND PERFORMED REVISION WITHOUT ANY INCIDENT.

  Patient problems: Discomfort; No Code Available

  MAUDE report 8623645 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON HAD TO REVISE AN SIGMA TC3 AND MBT REVISION TIBIA DUE TO PATIENT DISCOMFORT AND INSTABILITY. SURGEON REMOVED ALL EXISTING IMPLANTS AND PERFORMED REVISION WITHOUT ANY INCIDENT.

  Patient problems: Discomfort; No Code Available

  MAUDE report 8623566 ↗