P.F.C. SIGMA 1581-26-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295064824), received between Mar 4, 2019 and Mar 4, 2019 — 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.

• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. WASHOUT AND A POLY SWAP WAS PERFORMED. A TRIAL REDUCTION WAS PERFORMED WITH A SIZE 6 10MM PS INSERT AND FOUND TO BE SATISFACTORY. THE REAL IMPLANT WAS THEN INSERTED AND THE CLOSING PROCESS BEGAN. THE SURGEON WHO PERFORMED THE REVISION WAS THE ORIGINAL IMPLANTING SURGEON, BUT WAS UNSURE OF THE DATE HE PERFORMED THE SURGERY. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8387524 ↗