P.F.C. SIGMA 86-6410Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295216933), received between May 28, 2020 and Nov 29, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K241000, K882234, K952830); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE PRIMARY SURGERY. THIS PC REPORTS ABOUT THE REMOVAL SURGERY DUE TO INFECTION. AFTER THE REVISION TKA SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL SURGERY ON (B)(6) 2021 BECAUSE INFECTION OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12882807 ↗
• MalfunctionMay 28, 2020Inaccurate Information; Inaccurate Information

  CUSTOMER IS COMPLAINING THE INFO ON THE LABEL. THE MEDICAL DEVICE IS LABELLED AS "CEMENTED", BUT IT IS A DEVICE THAT WILL NOT BE CEMENTED. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10098483 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K882234, K952830. One submission often covers many models, so check the product and lot details in each record.

• Z-2949-2018 · Jul 18, 2018 · Terminated
  P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
• Z-0396-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521.
• Z-0400-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544.
• Z-0399-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527.
• Z-0401-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551.
• Z-0398-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0523.
• Z-0397-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522.
• Z-1369-04 · Dec 22, 2003 · Terminated
  P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703