P.F.C. SIGMA 96-2145Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295241355), received between Sep 4, 2019 and Nov 13, 2025 — 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.

• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD DEVELOPED PAINFUL LAXITY OVER TIME. THE COMPONENTS APPEARED TO BE WELL FIXED. A REVISION KNEE WAS SCHEDULED TO ADDRESS LAXITY. DURING THE OPERATION, IT WAS NOTED THAT THERE WAS METAL DEBRIS BEING GENERATED BY THE PROSTHESIS AS THERE WAS STAINING THROUGHOUT THE CAPSULE. THE FEMORAL COMPONENT WAS REMOVED, AND IT APPEARED THAT THE DEBRIS WAS BEING GENERATED AT THE TAPER BETWEEN THE FEMORAL ADAPTER AND THE FEMORAL SLEEVE; BOTH OF WHICH WERE WELL FIXED. THE WELL-FIXED TIBIAL TRAY WAS REMOVED. TRIALS WERE PLACED AND MOTION AND STABILITY WAS CONFIRMED. FINAL COMPONENTS WERE PLACED. NO PATIENT HARM NOR DELAY WAS NOTED. PATIENT APPEARED HAVE HAD THICKER INSERTS PLACED ON (B)(6) 2020 AND (B)(6) 2021. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23543500 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH A PS PFC / MBT REVISION IN SITU FROM A PREVIOUS REVISION OF A HOWMEDICA PRIMARY KNEE (PRIMARY FROM 1998, 1ST REVISION NOVEMBER 2007), SYMPTOMS OF PAIN, FIXED FLEXION DEFORMITY AND PATELLA BAHA. DR INGLIS PERFORMED SYNOVECTOMY, REMOVED CALCIFICATION FORM PATELLA TENDON AND EXCHANGED POLY BEARING, DOWNSIZED FROM 20MM IMPLANTED IN 2007 TO A 17.5MM.

  Patient problems: Joint Disorder; No Code Available; Pain

  MAUDE report 8958820 ↗