P.F.C. SIGMA 1581-02-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295062455), received between Oct 8, 2020 and Jul 6, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RECURRENT DRAINAGE FROM INCISIONAL AREA : INFECTION ON (B)(6) 2021, THE PATIENT PRESENTED FOR A CLINIC VISIT FOR AN EVALUATION DUE TO RIGHT KNEE DRAINAGE AND EDEMA. CULTURES REVEALED STAPHYLOCOCCUS EPIDERMIDIS AND CANDIDA. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS WOUND DRAINAGE, RECURRENT INFECTION, AND EDEMA. THE POST-OPERATIVE DIAGNOSIS WAS INDICATED AS RECURRENT INFECTION WHILE THE "FINDINGS" SECTION OF INTRA-OP NOTE DESCRIBED THE INFECTION AS CHRONIC. THE SURGEON NOTED THERE WAS AN EROSION OF THE MIDDLE PORTION OF THE EXTENSOR MECHANISM JUST AT THE LEVEL OF THE JOINT LINE. (IT IS INDICATED THE PATIENT PREVIOUSLY UNDERWENT AN EXTENSOR MECHANISM RECONSTRUCTION IN (B)(6) 2020 TO ADDRESS A RUPTURED EXTENSOR MECHANISM. CAPTURED ON (B)(4).) THE SURGEON ALSO NOTED REMOVAL OF NECROTIC-APPEARING TISSUE. ALL COMPONENTS WERE REMOVED AND WERE REPLACED WITH A SURE SPACE FEMORAL SPACER AND SURE SPACE TIBIAL SPACER. TWO GRAMS OF VANCOMYCIN AND 100 MG OF AMPHOTERICIN WERE USED PER BATCH OF CEMENT. TWO BATCHES OF DEPUY 2 WITH GENTAMICIN CEMENT WAS UTILIZED. THE SURGEON INDICATED THE PATIENT WOULD BE ON IV ANTIBIOTICS POST-OPERATI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fluid Discharge; Necrosis; Swelling/ Edema

  MAUDE report 12121164 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DELAYED WOUND CLOSURE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020 (INSERT). DATE OF EVENT:(B)(6) 2020. (RIGHT KNEE). TREATMENT: IRRIGATION AND DEBRIDEMENT.

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 10653456 ↗

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-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-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.
• 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-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-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-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.