P.F.C. SIGMA 1581-12-117Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295063308), received between Jun 18, 2021 and Oct 10, 2024 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2024Adverse 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 INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20417446 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND DEHISCENCE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: WOUND VAC.

  Patient problems: Wound Dehiscence

  MAUDE report 16784898 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DRAINING SORE CLOSE TO HER LEFT TOTAL KNEE INCISION : COMPLEX FLUID COLLECTION OR COMPLEX CYST WHICH AFTER SHE ABRADED IT SOME, WITH APPLICATIONS OF VOLTAREN GEL, HAS TUNED INTO AN ULCER OR SORE WHICH HAS NOT HEALED EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2008. DATE OF REVISION: (B)(6) 2016 (INSERT, FOR INFECTION), DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: SURGICAL IRRIGATION AND DEBRIDEMENT (NO PRODUCTS REVISED).

  Patient problems: Cyst(s); Pressure Sore/Ulcer

  MAUDE report 12437143 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS CONFIRMED INFECTION. AN ANTIBIOTIC SPACER WAS PLACED. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 12026011 ↗