P.F.C. SIGMA 1581-24-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295064510), received between Dec 13, 2017 and Sep 21, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Misconnection” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE'S NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17790040 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PRIMARY KNEE AND EXPERIENCED POST CAR ACCIDENT KNEE PAIN.

  Patient problems: Pain

  MAUDE report 17606981 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. DOI: (B)(6) 2013; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15163630 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS INFECTION. DR. INFORMED THAT THE PATIENT BECAME SICK. THE KNEE WAS SHOWING SIGNS OF INFLAMMATION, SO DR. WANTED TO PERFORM AN I & D WITH POLY EXCHANGE. THE KNEE WAS DONE BY ANOTHER DR. AT (B)(6), BUT THE DR. WAS UNSURE OF THE EXACT DATE OF THE ORIGINAL PROCEDURE. UPON REMOVING THE POLY, THEY WERE ABLE IDENTIFY THAT IT WAS A SIZE 4 15MM STABILIZED INSERT. HE FELT THAT IT WOULD BE BEST TO REPLACE IT WITH THE SAME SIZE COMPONENT. HE THOROUGHLY WASHED OUT THE JOINT, THEN INSERTED THE NEW POLY. LEG WAS FOUND TO BE STABLE AND THE CLOSING PROCESS BEGAN. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 12923103 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE PATIENT WAS REVISED DUE TO INSTABILITY. EXCHANGING POLY WAS DONE. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9234828 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9162630 ↗
• MalfunctionDec 13, 2017Misconnection; Misconnection

  THE PATIENT WAS REVISED TO ADDRESS INFLAMMATION. IT WAS ALSO STATED THAT THE KNEE WAS NOT INFECTED, THE ORIGINAL LINER WAS PULLED OUT AND A NEW LINER WAS PUT BUT IT WOULD NOT LOCK. ANOTHER LINER WAS USED. DOI: UNKNOWN; DOR:(B)(6) 2017; RIGHT KNEE.

  Patient problems: Inflammation

  MAUDE report 7113943 ↗