P.F.C. SIGMA 1581-02-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295062448), received between Feb 7, 2020 and Sep 24, 2021 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS REVIEWED AND INDICATED THAT ON AN UNKNOWN DATE APPROXIMATELY TWO MONTHS FOLLOWING THE PRIMARY OPERATION, THE PATIENT UNDERWENT A REPAIR OF THE RIGHT KNEE FOR A RUPTURED PATELLA TENDON AND AVULSION OF THE INFERIOR POLE OF THE PATELLA. TASK INITIATED TO CREATE NEW PC TO CAPTURE EVENT. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS INFECTION, PAIN, DISCOMFORT, SWELLING, WALKING DIFFICULTY, EFFUSION, DECREASED RANGE OF MOTION, FEVER, AND CHILLS. THE SURGEON REVISED THE TIBIAL INSERT, PERFORMED AN IRRIGATION AND DEBRIDEMENT, AND PLACED OF ANTIBIOTIC PELLETS. PATELLA ALTA WAS NOTED AS THE EXTENSOR MECHANISM WAS INTACT BUT ABOUT 2 CM BELOW THE INFERIOR POLE OF THE PATELLA. THE PATELLA WAS CORRECTED WITH 3 STITCHES TO PLACE IT IN A MORE NORMAL POSITION. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Discomfort; Fever; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 12525568 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RIGHT KNEE WAS UNFORTUNATELY BECOME INFECTED. PATIENT UNDERWENT BILATERAL SIGMA FIXED BEARING KNEE REPLACEMENTS IN APRIL. AN I&D WAS PERFORMED AND POLY SWAP WAS DONE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12489322 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY: (B)(4). CLINICAL NOTIFICATION RECEIVED FOR REVISION TO ADDRESS INFECTION DATE OF IMPLANTATION: (B)(6) 2020. DATE OF REVISION: (B)(6) 2021. (RIGHT KNEE) TREATMENT: REVISION, REMOVAL OF ALL IMPLANTS, WITH PLACEMENT OF AN ANTIBIOTIC SPACER PRODUCT DETAILS: CATALOG: 158102112. LOT: 8943702. DESCRIPTION: SIGMA BANNISTER P/LIPPED XLK INSERT 2.5 12.5MM. CATALOG: 960018. LOT: D18102253. DESCRIPTION: SIGMA FEM C/RET CEMENTED RT SZ 2.5. CATALOG: 158125000. LOT: 9472648. DESCRIPTION: SIGMA BANNISTER TIBIAL TRAY CEMENTED SZ 2.5. CATALOG: 3312040. LOT: 9282835. DESCRIPTION: SMART SET CMW 1 40G. CATALOG: 3312040. LOT: 9282835. DESCRIPTION: SMART SET CMW 1 40G.

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

  MAUDE report 12027350 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11716869 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF REVISION: (B)(6) 2020; (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Erythema; Fluid Discharge; Inflammation; No Code Available; No Consequences Or Impact To Patient; Pain; Unspecified Infection

  MAUDE report 10527878 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED AND REVIEWED: ON (B)(6) 2020, THE PATIENT UNDERWENT A RIGHT KNEE REVISION OF THE TIBIAL INSERT TO ADDRESS AN ACUTE INFECTION. THE SURGEON INDICATED THE KNEE ARTHROPLASTY OCCURRED 3 TO 4 WEEKS PRIOR TO THIS CURRENT REVISION. ANTIBIOTIC PELLETS WERE ALSO PLACED. LEADING UP TO THE REVISION THE PATIENT WAS EXPERIENCING PAIN, DRAINAGE, INFLAMMATION, AND INSTABILITY. THE SURGEON NOTED WHEN ATTEMPTING TO COMPLETE CLOSURE OF THE WOUND, THERE WAS A SMALL AREA OF ABOUT 4 TO 5 CM BELOW THE TIBIAL PLATEAU THAT WAS SOMEWHAT DEFICIENT. THE SURGEON OVER SEWED THIS WITH SUBCUTANEOUS TISSUE. ON (B)(6) 2020, THE PATIENT PRESENTED FOR A RIGHT KNEE EVALUATION WITH DRAINAGE AND DELAYED WOUND HEALING. THE WOUND WAS BEING TREATED WITH A WOUND VAC. ON (B)(6) 2020, THE PATIENT PRESENTED FOR A RIGHT KNEE REVALUATION WITH SLIGHT DRAINAGE AND CONTINUED USE OF THE WOUND VAC. ON (B)(6) 2020, THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT DUE TO DELAYED WOUND HEALING AND TO COMPLETE CLOSURE OF THE WOUND. NO PRODUCTS WERE REVISED DURING THE PROCEDURE.

  Patient problems: Erythema; Fluid Discharge; Inflammation; No Code Available; Pain; Unspecified Infection

  MAUDE report 10503387 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, PATIENT WAS REVISED TO ADDRESS GLOBAL INSTABILITY OF THE LEFT KNEE. PATIENT PRESENTED WITH PAIN, DISCOMFORT, RECURRENT EFFUSION, AND GLOBAL INSTABILITY. NO EVIDENCE OF LOOSENING OR INFECTION WAS IDENTIFIED. ALL PRODUCTS WERE FOUND TO BE WELL-FIXED INTRAOPERATIVELY. INSERT WAS UPSIZED, TISSUE RELEASES PERFORMED, AND STABILITY ACHIEVED.

  Patient problems: Discomfort; Edema; No Code Available; Pain

  MAUDE report 10489808 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. 2.5 12.5MM PLI WAS EXCHANGED FOR A 17.5 TO ACHIEVED EXCELLENT STABILITY. ALL IMPLANT INTERFACES ON TIBIA, FEMUR AND PATELLA WERE WELL FIXED. DOI: (B)(6) 2019 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10471562 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE REVIEWED AND WAS NOTED THAT ON (B)(6) 2020 , THE PATIENT UNDERWENT A LEFT CEMENTED TOTAL KNEE ARTHROPLASTY AND A RIGHT CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS, END-STAGE, BILATERAL KNEES. THERE WERE NO COMPLICATIONS NOTED. MEDICAL RECORDS FROM (B)(6) 2020 NOTE THAT THE PATIENT DEVELOPED A GI BLEED, THEN DEVELOPED A DVT AND AN IVC FILTER WAS INSERTED. KNEES HAVE BEEN DOING WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Thrombosis

  MAUDE report 10434433 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BLOOD CLOTS TO LEG AND LUNGS : VASCULAR - PULMONARY EMBOLUS AND DVT. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO BOTH DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2019; (LEFT KNEE).

  Patient problems: No Code Available; Pulmonary Embolism; Thrombosis

  MAUDE report 9683309 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BLOOD CLOTS TO LEG AND LUNGS : VASCULAR - PULMONARY EMBOLUS AND DVT. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO BOTH DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2019; (RIGHT KNEE).

  Patient problems: Edema; Pain; Pulmonary Embolism; Thrombosis

  MAUDE report 9683157 ↗

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-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-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-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-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-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-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.