P.F.C. SIGMA 96-2053Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295240952), received between Apr 8, 2019 and Nov 4, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT HAD KNEE IN FOR 15 PLUS YEARS. THE POLY SPUN OUT WHILE DOING ACTIVITIES AT HOME. THE SURGEON REPLACED THE POLY WITH A THICKER INSERT. STABLE ALL AROUND. ACTIVITY LEVEL - YES. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23467528 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION IN LEFT TOTAL SIGMA KNEE. THE SURGEON DID A WASHOUT WITH A TIBIAL INSERT EXCHANGE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20705499 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS TO CAPTURE PATIENTS¿ PRIOR REVISIONS REPORTED IN (B)(4). THIS WAS THE FIRST REVISION PROCEDURE FOR THIS PATIENT. PATIENT UNDERWENT A LEFT PRIMARY TOTAL KNEE REPLACEMENT (TKR) ON (B)(6)2009. REVISED ON (B)(6) 2009 TO TREAT PAIN. ONLY THE INSERT WAS REVISED.

  Patient problems: Pain

  MAUDE report 12176665 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: Pain

  MAUDE report 10924612 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. PATELLA IMPLANT HAD DELAMINATED AND SMALL POLY IN THE JOINT. TIBIAL INSERT EXCHANGED AT REVISION. UPDATE: SMALL POLY FRAGMENTS WERE FROM THE PATELLA. DOI: (B)(6) 2005 ;DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8491394 ↗