P.F.C. SIGMA 96-2124Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295241201), received between Dec 12, 2018 and Nov 19, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ORIGINAL IMPLANT WAS FROM 2005. HIGH BMI SINCE WITH POLY WEAR. POLY EXCHANGE ONLY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23597768 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16271529 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT JOINT ASPIRATION OF THE RIGHT KNEE ON (B)(6) 2016: DUE TO SWELLING AND PAIN. THIS WAS DONE IN OFFICE. ADDITIONALLY, ON (B)(6) 2016 THE PATIENT WAS SEEN IN THE ER FOR PAIN, SWELLING AND DRAINAGE IN HER RIGHT KNEE. THE PATIENT WAS ADMITTED FOR SUSPECTED KNEE CELLULITIS AND SEPTIC ARTHRITIS. PATIENT ALSO HAD X-RAYS PERFORMED ON THAT DATE THAT WERE SUGGESTIVE OF PREPATELLAR BURSITIS WITH SMALL EFFUSION. WHILE HOSPITALIZED, THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT AND POLYETHYLENE EXCHANGE DUE TO CONFIRMED INFECTION OF THE RIGHT KNEE. DOI: (B)(6) 2015; DOR: (B)(6) 2016; DOR: (B)(6) 2016 (I&D WITH POLY EXCHANGE).

  Patient problems: Cellulitis; Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 9544842 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8155521 ↗