P.F.C. SIGMA 1581-02-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295062424), received between Sep 13, 2018 and May 6, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. THE SURGEON WASHED OUT KNEE AND SWAPPED INSERT. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2008. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21972547 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WASHED THE PATIENT OUT AND SWITCHED THE POLY WHILE IN THERE.

  Patient problems: Insufficient Information

  MAUDE report 21729890 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11627761 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. NO LOOSENING REPORTED. DOI: UNKNOWN; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11619285 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE WAS ALSO REPORTED. A NON-DEPUY CEMENT WAS USED. NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2018. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 11213008 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). 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. DOI: (B)(6) 2019; DOE: (B)(6) 2019. TREATMENT INCLUDES LYTIC THERAPY. PLEASE NOTE, THIS PATIENT HAD BILATERAL PRIMARY KNEE REPLACEMENTS ON (B)(6) 2019. THIS PC CAPTURES THE LEFT KNEE IMPLANTS.

  Patient problems: Infarction, Cerebral

  MAUDE report 8546504 ↗
• InjurySep 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY USING DEPUY PFC SIGMA IMPLANTS. THE FEMORAL, TIBIAL, POLYETHYLENE, AND PATELLA COMPONENTS WERE EXPLANTED AND A COMPETITIVE SPACER BLOCK WAS PLACE IN. DOI: INSERT - (B)(6) 2017; FEMUR, TIBIAL TRAY AND PATELLA UNKNOWN DOI; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7872197 ↗

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-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-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-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-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.