P.F.C. SIGMA 1581-05-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295062806), received between Jul 23, 2021 and Jun 2, 2025 — classified as 3 injuries.

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

8 other recalls cover devices cleared under the same FDA submission (K040166, K082500, K241000, K943462); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY AND TIBIAL BONE GRAFT TO ADDRESS END-STAGE OSTEOARTHRITIS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2018, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE REPLACEMENT TIBIAL AND FEMORAL COMPONENT TO ADDRESS FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO WEAR AND SYNOVITIS. THE INDICATIONS FOR SURGERY INCLUDED EPISODES OF RECURRENT SCAR FORMATION, WHICH REQUIRED EARLY MANIPULATION AND EXCISION. A REPEAT ARTHROSCOPIC EXCISION FOR SCAR TISSUE AND THEN UNDERSIDE OF THE QUAD TENDON AND NOW WITH RECURRENT STIFFNESS AND SWELLING. RADIOGRAPHS WERE REPORTED TO SHOW A RADIOLUCENT LINE AROUND THE FEMORAL COMPONENT. DURING THE PROCEDURE, THE SURGEON OBSERVED THE POLYETHYLENE HAD BOTH FRONT SIDE AND BACKSIDE WEAR. THE SIGMA PFC KNEE HAD A RELATIVELY HIGH DEGREE OF POSTERIOR SLOPE ON THE TIBIAL SIDE AND THE FEMORAL IMPLANT DID NOT HAVE GROSS MOTION, BUT WAS RELATIVELY EASY TO REMOVE AFTER BREAKING UP THE INTERFACES WITH MINIMAL BONE INGROWTH INTO THE INGROWTH SURFACES ON THE BACKSIDE OF THE IMPLANT. IT WAS NOTED THAT THE BACKSIDE OF THE IMPLANTS HAVE SMALL AREAS OF SPOT WELDING, BUT THE REMA

  Patient problems: Adhesion(s); Muscular Rigidity; Swelling/ Edema; Synovitis

  MAUDE report 22123478 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20345456 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE NOT LOOSENED. THEY WERE WELL FIXED TO THE BONE. THEY WERE REMOVED DUE TO INFECTION. DOI: (B)(6) 2013. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12219683 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040166, K082500, K241000, K943462. One submission often covers many models, so check the product and lot details in each record.

• Z-1077-2014 · Dec 9, 2013 · Terminated
  PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
• Z-1686-2009 · May 7, 2009 · Terminated
  DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. The devic
• Z-0406-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651.
• Z-0402-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 2.5, 8 mm, 67mm M/L, 45 mm A/P, UHMWPE, 2.5, sterile; Product Code/REF 96-0630.
• Z-0405-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650.
• Z-0407-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 5, 15mm, 83mm M/L, 55mm A/P, UHMWPE, sterile; Product Code/REF 96-0663.
• Z-0403-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 8 mm, 71mm M/L, 47 mm A/P, UHMWPE, sterile; Product Code/ REF 96-0640.
• Z-0404-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 10mm, 71mm M/L, 47mm A/P, UHMWPE, sterile; Product Code/REF 96-0641.