P.F.C. SIGMA 96-2167Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295241560), received between Aug 30, 2018 and Aug 30, 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.

• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. IT WAS ALSO REPORTED THAT THE TIBIA WAS WELL FIXED BUT TAKEN OUT DUE TO INFECTION. DOI: 2015 FOR THE FEMORAL ADAPTOR, FEMORAL BOLT AND (2) TIBIAL STEM , DOI: (B)(6) 2018 FOR FEMUR, INSERT AND TIBIAL TRAY, DOR: (B)(6) 2018 , LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7832238 ↗