P.F.C. SIGMA 1581-12-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295063292), received between Jan 15, 2018 and Mar 2, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION - DEEP EVENT IS SERIOUS AND IS CONSIDERED SEVERE. THERE IS A REMOTE POSSIBILITY EVENT IS RELATED TO DEVICE AND IS THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: REVISION ON (B)(6) 2021 WITH I&D, COMPLETE SYNOVECTOMY, REEFING OF THE PATELLAR TENDON AND AN EXCHANGE OF THE TIBIAL INSERT COMPONENT.

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13654626 ↗
• InjuryJan 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATES THAT THE PATIENT WAS REVISED TO ADDRESS INFECTION TO THE KNEE AREA. POLY INSERT REMOVED AND ANTIBIOTIC PELLETS PLACED IN KNEE CAPSULE. NEW 2.5 X 15MM INSERT IMPLANTED. THE ORIGINAL DATE OF IMPLANT IS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2017; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7191654 ↗