P.F.C. SIGMA 96-2155Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295241447), received between Sep 26, 2017 and Jan 30, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21275369 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REMOVAL OF ALL IMPLANTS DUE TO INFECTION, PRIMARY SURGERY WAS IN 2014 WITH A POLY EXCHANGE IN 2015. DOI: 2014-15. DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12505482 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. NO ADDITIONAL INFORMATION WAS AVAILABLE. DOI: (B)(6) 2016 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11251842 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10258547 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT TOTAL KNEE WAS REVISED FOR LAXITY IN JOINT. PREVIOUS TOTAL KNEE WAS IMPLANTED IN 2001 AND WAS A SIGMA PS FEMUR SZ 5, SIGMA RP TIBIA SZ 5, SIGMA PS RP INSERT SZ 5 10MM. THE INSERT WAS EXCHANGED FOR A SIGMA PS RP INSERT SZ 5 20MM. THE SURGEON HAD A GREAT DEAL OF TROUBLE REDUCING THE 20MM INSERT CAUSING THE IMPLANT TO SLIP OUT OF HIS HANDS AND FALL ON THE FLOOR. A SECOND IMPLANT WAS BROUGHT FROM ANOTHER FACILITY TO REPLACE THE ONE THAT WAS NO LONGER STERILE. AFTER A GREAT DEAL OF EFFORT THE KNEE WAS REDUCED. AT THIS POINT THE SURGEON NOTICED BLEEDING IN THE BACK OF THE KNEE AND CALLED FOR A VASCULAR SURGEON TO HELP WITH HEMOSTASIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Not Applicable

  MAUDE report 9701651 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTED LEFT TOTAL KNEE. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9135801 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. (B)(6) - REVISION FOR TIBIAL PAIN. PRIMARY IMPLANT DATE UNKNOWN. THE 1ST REVISION (B)(6) 2014. REVISION (B)(6) 2018 FOR TIBIAL PAIN. (UNKNOWN MBT REVISION SZ 5).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Not Applicable; Pain

  MAUDE report 7826090 ↗
• InjurySep 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS YEAST INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6894464 ↗