SIGMA 96-0016Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295232056), received between Oct 4, 2019 and Jan 3, 2024 — classified as 5 injuries.

8 other recalls cover devices cleared under the same FDA submission (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18441017 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. NO INDICATION OF A PROBLEM WITH THE PRODUCTS. DOI: (B)(6) 2021 DOR; (B)(6) 2021 RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12961958 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND SWELLING. KNEE WAS INFECTED AND REMOVED IMPLANTS. INSERTED ANTIBIOTIC SPACER WAS DONE. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2016 (FEMORAL, PATELLA AND TIBIAL TRAY). (B)(6) 2019 (TIBIAL INSERT). DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 12438791 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GLOBAL INSTABILITY. 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 REVISION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (RIGHT KNEE).

  Patient problems: No Code Available

  MAUDE report 9311280 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. REVISED FEMORAL COMPONENT TO POSTERIOR STABILIZED. IT WAS ALSO REPORTED THAT POLY WAS WORN. DOI: (B)(6) 2002; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9156998 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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-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-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-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-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.