P.F.C. SIGMA 1581-23-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295064350), received between Jun 30, 2017 and Mar 27, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REPLACED THE POLY WITH THE SAME SIZE WHEN HE WENT IN TO WASH OUT THE KNEE DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21707791 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIBIA PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21068861 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT KNEE. PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) AND POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2012 DOR: JUNE 13, 2024, AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19624481 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. POLY EXCHANGE WAS DONE. NO ADDITIONAL INFORMATION. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11365435 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO KNEE INSTABILITY. DOI: (B)(6) 2013; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9280159 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS EXCHANGED DUE TO TIGHT KNEE. NO ADDITIONAL INFORMATION. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8683265 ↗
• MalfunctionJun 20, 2018Fitting Problem; Fitting Problem

  DER STATES THAT THE SURGEON TRIED TO PUT INSERT IN TO TIBIAL TRAY AND IT WOULD NOT LOCK LATERALLY. DOE: (B)(6) 2018. RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7620758 ↗
• InjuryAug 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDESS PAIN AND POSSIBLE INFECTION. STAGING AN EXPLANT WITH POLYSWAP TO SEE IF INFECTION WAS PRESENT.

  Patient problems: Pain

  MAUDE report 6763229 ↗
• InjuryJul 5, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6688042 ↗
• InjuryJun 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. IT ALSO STATES THAT THEY REPLACED THE POLY AND USED ANTIBIOTIC BEADS.

  Patient problems: Unspecified Infection

  MAUDE report 6680097 ↗