P.F.C. SIGMA 96-0890Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295234432), received between Oct 23, 2019 and Jul 7, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS FRACTURE BELOW THE TIBIA IMPLANT AND LOOSENING OF THE TIBIAL COMPONENT AT THE UNKNOWN INTERFACE. UNKNOWN CEMENT WAS USED. IT WAS REPORTED THAT THE TC3 AND MBT TRAY COMPONENTS WERE EXPLANTED, THE FRACTURE WAS REDUCED AND PLATED BY ANOTHER SURGEON. AN ATTUNE REVISION CONSTRUCT WAS IMPLANTED IN PLACE. NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12127555 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF FEELING UNSTABLE. THE SURGEON ASSESSED THE KNEE AND FOUND THEM TO BE UNSTABLE IN FLEXION. HE DECIDED IT WOULD BE BEST TO REVISE THE FEMORAL COMPONENT TO ADDRESS THE INSTABILITY. HE MADE A CLEAN UP CUT DISTALLY, ADDED 8MM DISTAL AUGMENTS, 8MM POSTERIOR AUGMENTS WITH A 46 FEMORAL SLEEVE AND 75X16 STEM. POLY WAS UPSIZED TO SZ 4 22.5MM THICK INSERT. KNEE WAS FOUND TO BE STABLE AND THE CLOSING PROCESS BEGAN. DOI: 2009; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9226556 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF FEELING UNSTABLE. THE SURGEON ASSESSED THE KNEE AND FOUND THEM TO BE UNSTABLE IN FLEXION. HE DECIDED IT WOULD BE BEST TO REVISE THE FEMORAL COMPONENT TO ADDRESS THE INSTABILITY. HE MADE A CLEAN UP CUT DISTALLY, ADDED 8MM DISTAL AUGMENTS, 8MM POSTERIOR AUGMENTS WITH A 46 FEMORAL SLEEVE AND 75X16 STEM. POLY WAS UPSIZED TO SZ 4 22.5MM THICK INSERT. KNEE WAS FOUND TO BE STABLE AND THE CLOSING PROCESS BEGAN. DOI: 2009; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9226555 ↗