P.F.C. SIGMA 96-2146Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295241362), received between Oct 3, 2018 and May 13, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. HE HAD HIS KNEE REPLACED SOME TIME AGO BY ANOTHER SURGEON AND HAS HAD 6 REVISION SURGERIES AFTER HIS ORIGINAL TKA. THE ORIGINAL IMPLANT DATE IS UNKNOWN. IT WAS REPORTED THAT THE SURGEON DOES NOT KNOW THE SPECIFICS ON WHAT SURGEON REVISED THE PATIENT'S KNEE OR EXACTLY WHEN THE REVISIONS TOOK PLACE. THE PATIENT CAME IN TO SEE THE SURGEON FOR INSTABILITY AND THE DECISION WAS MADE BY THE SURGEON AND THE PATIENT TO REVISE THE KNEE. DURING THE REVISION, THE SIGMA SZ 4 PS FEMUR AND SZ 4 X 22.5 RP INSERT WERE EXPLANTED. THE PATELLA AND THE TIBIAL TRAY WERE LEFT IN SITU. A NEW FEMORAL COMPONENT WITH STEM, AUGMENTS AND SLEEVE WERE IMPLANTED ALONG WITH A NEW BEARING. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11818947 ↗
• InjuryOct 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7930945 ↗