P.F.C. SIGMA 1581-04-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295062677), received between Apr 23, 2018 and Jul 31, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had a stiff knee. The doctor revised the construct except the patella to an Attune CRS W Short Stems on both the Fem and the tibia. DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown Knee.

  Patient problems: Muscular Rigidity

  MAUDE report 50100960 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ITEM EXPLANTED DUE TO POTENTIAL INFECTION. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20032065 ↗
• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO WOUND DEHISCENCE. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2023. (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Wound Dehiscence

  MAUDE report 16442790 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16140103 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR PE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022; RIGHT KNEE. TREATMENT: INJECTED MEDICATION (HEPARIN DRIP).

  Patient problems: Discomfort; Erythema; Pain; Pulmonary Embolism

  MAUDE report 15029238 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR PULMONARY EMBOLISM. EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE DATE OF IMPLANT: (B)(6) 2020; DATE OF EVENT: (B)(6) 2020; (RIGHT KNEE).

  Patient problems: Hypoxia; Respiratory Failure

  MAUDE report 9672952 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE SEPSIS : INFECTION - DEEP. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8902942 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY EXCHANGE FOR INFECTION. AN I&D AND EXCHANGE WAS PERFORMED. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8807000 ↗
• InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT AND CEMENT TO BONE INTERFACES. COMPETITOR CEMENT WAS USED. A REVISION WITH SIGMA MBT STEM AND SLEEVE WAS DONE. DOI: (B)(6) 2016. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8342857 ↗
• InjuryApr 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. IT WAS ALSO REPORTED IN THE DER THAT BONE SCAN SHOWED UPTAKE ON TIBIA. TIBIA WAS REPLACED WITH LONG STEM CONSTRUCT. DOI: (B)(6) 2012, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 7450172 ↗

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-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-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.
• 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.