P.F.C. SIGMA 96-2044Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295240846), received between Dec 19, 2018 and Sep 19, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

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.

• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED PAIN AND SWELLING. SCHEDULED FOR I AND D WITH POLY SWAP. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17775556 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CR150 LEFT KNEE REPLACEMENT REQUIRES REVISION DUE TO INSTABILITY IN BOTH FLEXION AND EXTENSION. PRIMARY PROCEDURE DATE: (B)(6) 2019.

  Patient problems: Joint Laxity

  MAUDE report 10889311 ↗
• MalfunctionDec 19, 2018Off-Label Use; Off-Label Use

  THE DISTRIBUTOR REPORTS THAT AN EXPIRED TIBIAL INSERT WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8179303 ↗