P.F.C. SIGMA 96-0892Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295234456), received between Mar 19, 2021 and Jul 7, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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. 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 12127548 ↗
• MalfunctionMar 24, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE INCIDENT OCCURRED DURING THE SURGERY WITH A 5 MINUTES DELAY TIME TO TAKE ANOTHER IMPLANT AND TO MAKE THE FINAL ASSEMBLY FOR THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11561802 ↗
• MalfunctionMar 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  WHEN OPENING THE IMPLANT, THE TWO PACKAGES ARE PIERCED: NON-STERILE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11532294 ↗