P.F.C. SIGMA 96-0843Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295234197), received between Jan 8, 2021 and Mar 18, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT KNEE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2014, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11517141 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: NOT INDICATED/UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11142663 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: NOT INDICATED/UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11142628 ↗