P.F.C. SIGMA 86-6444Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295217121), received between Dec 14, 2017 and Dec 14, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K241000, K882234, K952830); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2017Fracture; Fracture

  IT STATES THAT THE PATIENT WITH ABNORMAL GIGANTISM WILL UNDERGO REVISION BECAUSE OF FRACTURE OF S-ROM NOILES ROTATING HINGE KNEE STEM. UPDATE NOV 14, 2017 ADDITIONAL INFORMATION RECEIVED. CUSTOMER REPORTED TO (B)(6): CHANGE OF TIBIAL COMPONENTS OF KNEE-TEP ON (B)(6) 2011. IN (B)(6) 2017 A FRACTURE OF TAPER OF TIBIAL PART OF PROSTHESIS WAS SUSPECTED AFTER RADIOLOGICAL EXAMINATION. REVISION WITH CHANGE OF TIBIAL COMPONENTS ON (B)(6) 2017. INTRAOPERATIVELY A FRACTURE OF TAPER AT THE CONNECTION OF TIBIAL PLATEAU TO TIBIAL STEM WAS SEEN. UPDATE: 12/13/2017 MEDICAL RECORDS REVIEWED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, THERE WAS LOOSENING OF THE TIBIAL COMPONENT OF THE NOILES RIGHT-KNEE JOINT TEP WITH SCREW BREAKAGE AT THE TRANSITION FROM SLEEVE TO STEM. THE PATIENT THEN HAD INCREASED INSTABILITY AND FALLS. RADIOGRAPHS ARE REPORTED TO SHOW THE TIBIAL COMPONENT DISCONNECTED. DURING THIS REVISION, THE SURGEON NOTED A DISCOLORED SYNOVIA IN THE MANNER OF METALLOSIS AND AN OLD HEMATOMA. THE MEDICAL NOTES REPORTED THAT THE PATIENT WAS IMPLANTED WITH A NOILES KNEE PROSTHESIS ON (B)(6) 2011 DUE TO AN INFECTION OF PREVIOUS IMPLANT. CURRENTLY IT IS NOT KNOWN IF THOSE WERE DEPUY COMPONENTS.

  Patient problems: Bone Fracture(s); Foreign Body Reaction; Tissue Damage

  MAUDE report 7118657 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K882234, K952830. One submission often covers many models, so check the product and lot details in each record.

• Z-2949-2018 · Jul 18, 2018 · Terminated
  P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
• Z-0396-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521.
• Z-0398-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0523.
• Z-0401-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551.
• Z-0397-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522.
• Z-0399-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527.
• Z-0400-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544.
• Z-1369-04 · Dec 22, 2003 · Terminated
  P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703