P.F.C. SIGMA 96-0702Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295233633), received between Sep 12, 2018 and Sep 12, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY PERFORMED ON (B)(6) 2018. IT WAS REPORTED THAT THE SURGEON RECOGNIZED THAT INFECTION ON THE PATIENT¿S KNEE ON (B)(6) 2018. SINCE THE SURGEON COULD NOT CONTROL THE INFECTION, IMPLANTS WERE EXPLANTED FROM THE PATIENT'S KNEE JOINT DUE TO POSTOPERATIVE INFECTION, AND CEMENT SPACER WAS PLACED IN THE PATIENT'S KNEE JOINT FOR TREATMENT THE KNEE JOINT INFECTION ON (B)(6) 2018. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 7868752 ↗