P.F.C. SIGMA 96-0043Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295232230), received between Jul 25, 2018 and Jan 8, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 reports).

24 other recalls cover devices cleared under the same FDA submission (K241000, K950010, K952830, K971189); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Migration

  IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL LEFT KNEE REVISION PROCEDURE DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT DUE TO VARUS COLLAPSE AT THE NON-DEPUYSYNTHES BONE CEMENT INTERFACE AND PAIN.

  Patient problems: Pain

  MAUDE report 24005288 ↗
• InjuryDec 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PFC SIGMA STAB INS SZ3 8MM, PFC KEEL TIB TRAY CEM SZ3, PFC*SIGMA C/S NPOR FEM LT SZ 3, AND PFC*SIGMA/OV/DOME PAT 3PEG,38 WERE INVOLVED IN A REPORTED EVENT. THE PATIENT UNDERWENT PRIMARY TOTAL KNEE ARTHROPLASTY WITH THESE IMPLANTS, AND SUBSEQUENTLY REQUIRED REVISION SURGERY DUE TO LOOSENING AT THE TIBIA AND FEMUR. THE REVISION WAS COMPLETED SUCCESSFULLY USING PRODUCTS FROM ANOTHER COMPANY. ALL THREE COMPONENTS FEMORAL, TIBIAL TRAY, AND PATELLA WERE REVISED, WHILE THE TIBIAL INSERT WAS REPLACED TO ACCOMMODATE THE OTHER COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 23863544 ↗
• InjuryJun 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED VIA TKA WITH PFCS. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023 DUE TO LOOSENING. THE EVENT DATE AND THE REASON FOR THE LOOSENING IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17098681 ↗
• InjuryApr 28, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT AND IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2000. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16832908 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A FIRST-STAGE LEFT KNEE REVISION DUE TO INFECTION, PAIN, SWELLING, ERYTHEMA, DECREASED RANGE OF MOTION, AND FEMORAL COMPONENT LOOSENING AT AN UNKNOWN INTERFACE. THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT, REMOVAL OF ALL PRODUCTS, AND PLACEMENT OF COMPETITOR ARTICULATING ANTIBIOTIC SPACER. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2005, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Erythema; Loss of Range of Motion; No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 8944157 ↗
• InjuryOct 25, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR MIGRATION/LOOSENING OF THE TIBIAL COMPONENT. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DOI: (B)(6) 2007. DOE: (B)(6) 2018. (LEFT KNEE).

  Patient problems: No Code Available

  MAUDE report 8003964 ↗
• InjurySep 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL NOTIFICATION RECEIVED FOR REVISION RELATED TO PAIN AND STIFFNESS. DOI: (B)(6) 2001; DOR: (B)(6) 2018; (RIGHT KNEE).

  Patient problems: Not Applicable; Pain

  MAUDE report 7859604 ↗
• InjuryJul 25, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AND TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER USED WAS UNKNOWN. DOI: (B)(6) 2003; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7718692 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K950010, K952830, K971189. 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-0395-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 89 mm M/L, 59 mm A/P, 10.0 mm, 6, UHMWPE, sterile; Product Code/REF 96-0471.
• Z-0390-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 10.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0441.
• 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-0387-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 12.5 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0432.
• Z-0389-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 8.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0440.
• Z-0421-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 15 mm, 2, UHMWPE, sterile; Product Code/REF 96-2712.
• 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-0385-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0 mm, 2.5, sterile; Product Code/REF 96-0430.
• 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-0419-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 8.0mm, 4, UHMWPE, sterile; Product Code/REF 96-2650.
• Z-0392-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 10.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0451.
• Z-0394-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee SystemStabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 15.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0453.
• Z-0418-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 71mm M/L, 47mm A/P, 15.0mm, 3, UHMWPE, sterile; REF Product Code/96-2643.
• Z-0422-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 17.5 mm, 2, UHMWPE, sterile; Product Code/REF 96-2713.

…and 9 more.