P.F.C. SIGMA 1581-25-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295064671), received between Jul 2, 2018 and Dec 2, 2024 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID A WASH OUT OF THE KNEE WITH A POLY SWAP. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20820449 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH AN ACUTE SORE LEFT KNEE WITH EFFUSION. THE SURGEON ELECTED TO DO A I&D POLY EXCHANGE ON THE PATIENTS LEFT KNEE AT HOSPITAL ON (B)(6) 2024. THE SURGEON REMOVED THE INDEX POLY INSERT, PERFORMED HIS PROTOCOL FOR AN ACUTE INFECTED KNEE, AND THEN IMPLANTED A NEW POLY INSERT. NOTHING BROKE DURING SURGERY. THERE WAS NO INDICATION OF A COMPONENT NOT WORKING AS EXPECTED, NOTHING WAS LOST. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2013. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Swelling/ Edema; Unspecified Infection

  MAUDE report 20577480 ↗
• InjurySep 5, 2024Adverse 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) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20147712 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON INFORMED THAT THE ORIGINAL SURGERY WAS DONE AT (B)(6). HE WAS NOT SURE OF THE ORIGINAL IMPLANTATION DATE THOUGH. PATIENT WAS DEALING WITH SOME INSTABILITY OF THEIR KNEE, SO SURGEON FELT THEY WOULD BENEFIT FROM A POLY EXCHANGE. THE ORIGINAL POLY WAS REMOVED AND A TRIAL REDUCTION WAS PERFORMED. A NEW POLY WAS OPENED AND THE KNEE WAS FOUND TO BE STABLE. THE CLOSING PROCESS BEGAN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16610287 ↗
• InjuryNov 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D WITH POLY SWAP WAS DONE DUE TO SUSPECTED INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: OCT 18, 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15721861 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LIMITED MOTION. DOI: (B)(6) 2019 ; DOR: (B)(6) 2021 ; LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 13009477 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTED JOINT. NO LOOSENING REPORTED. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 12229579 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. IT WAS REPORTED THAT A SIGMA KNEE WAS TREATED THROUGH A 2-STAGE SURGERY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10102941 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S WOUND GOT OPENED UP ALL THE WAY TO THE JOINT. AN I&D WAS PERFORMED AND THE POLY WAS EXCHANGED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9504032 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSERT AND PATELLA EXCHANGE. DOI: (B)(6) 2018, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9105445 ↗
• InjuryJul 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS STIFFNESS AND PAIN. SURGEON CLEANED UP THE JOINT SPACE AND PUT IN A NEW POLY. DOI: (B)(6) 2006; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7655135 ↗