P.F.C. SIGMA 1581-02-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295062431), received between Apr 5, 2018 and Jun 25, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A POLY SWAP DUE TO INFECTION. THERE WAS NO NEED TO UPSIZE THE THICKNESS OF THE POLY AS THE JOINT WAS STABLE WITH THE SAME. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22332328 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND UNDERWENT POLY EXCHANGE DUE TO STIFFNESS. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 18291540 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SWELLING, HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: ASPIRATION/DRAINAGE AND ORAL MEDICATION (CELEBREX).

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 15966104 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH A SEPTIC KNEE. THE SURGEON DECIDED TO EXCHANGE THE POLY INSERT AFTER WASHING OUT THE KNEE. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15155775 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SWELLING : HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS REMOTE POSSIBILITY RELATED TO DEVICE AND IS REMOTE POSSIBILITY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2022; DATE OF EVENT (ONSET): (B)(6) 2022 (RIGHT KNEE). TREATMENT: KNEE ASPIRATION/DRAINAGE; ORAL MEDICATION - CELEBREX.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 14082701 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF THE FEMORAL COMPONENT, POSSIBLE DEEP INFECTION: ULCER ON KNEE AS A RESULT OF CUPPING OF HER KNEE AND THIS IS DRAINING; LOOSENING OF THE FEMUR ON X-RAY EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2022. (RIGHT KNEE). TREATMENT: NONE - REVISION SURGERY PENDING.

  Patient problems: Abscess; Fluid Discharge; Pain; Unspecified Infection

  MAUDE report 14017506 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MID FLEXION INSTABILITY. DOI: (B)(6) 2019 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11710767 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - DEEP VEIN THROMBOSIS; ALSO HAD A RELATED GI BLEED. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020 (BILATERAL). DATE OF EVENT (ONSET): (B)(6) 2020. (RIGHT AND LEFT KNEES. THIS COMPLAINT CAPTURES THE LEFT KNEE). TREATMENT: SURGICAL PLACEMENT OF IVC FILTER IMPLANTATION, AS WELL AS CLIPPING OF THE GI BLEEDER (MEDICAL CONSULT FOR DIAGNOSIS AND TREATMENT).

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

  MAUDE report 10442994 ↗
• InjuryApr 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION - FEMORAL/ TIBIAL: ANTERIOR TIBIAL. DISLOCATION WITH MEDIAL TRANSLATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2020; (RIGHT KNEE). TREATMENT: KNEE IMMOBILIZER WITH POSSIBLE KNEE REVISION IF INSTABILITY PERSISTS.

  Patient problems: Edema; Fall; Joint Dislocation; No Code Available; Pain

  MAUDE report 9971853 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ISCHEMIC STROKE DUE TO PATENT FORAMEN OVALE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. TREATMENT INCLUDES LYTIC THERAPY.

  Patient problems: Infarction, Cerebral; Muscular Rigidity

  MAUDE report 8541024 ↗
• InjuryApr 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR FEELINGS OF INSTABILITY. TREATMENT INCLUDES REVISION OF INSERT. DOI: (B)(6) 2017. DOE: (B)(6) 2018. DOR: (B)(6) 2018. (LEFT KNEE).

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7399001 ↗

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-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-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.