P.F.C. SIGMA 96-0869Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295234326), received between Apr 22, 2019 and Apr 23, 2019 — 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.

• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT LEFT ARTHROSCOPY AND DEBRIDEMENT FOR EXCESSIVE SCARRING, PAIN AND DECREASED ROM TO THE LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain; Scarring

  MAUDE report 8539321 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE 03 JAN 2019: ON (B)(6) 2014, 3 DAYS AFTER LEFT TKA REVISION, PATIENT DEVELOPED PULMONARY EDEMA AND CONGESTIVE HEART FAILURE WITH POSSIBLE MI. HE UNDERWENT A CABG X 5 FOR 3 VESSEL CARDIAC DISEASE ON (B)(6) 2014. PATIENT DEVELOPED BILATERAL PLEURAL EFFUSIONS AND INFECTION AFTER CABG REQUIRING STERNAL WOUND VAC AND IV ANTIBIOTIC ON (B)(6) 2014. DOI: (B)(6) 2014, DOE: (B)(6) 2014.

  Patient problems: Heart Failure; Myocardial Infarction; Pleural Effusion; Pulmonary Edema; Unspecified Infection

  MAUDE report 8537411 ↗