P.F.C. SIGMA 96-2630Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295243533), received between Jul 13, 2017 and Feb 10, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).

39 other recalls cover devices cleared under the same FDA submission (K241000, K943462, K950010, K952830, K961685, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF INSTABILITY IN THE KNEE POST TKA. THE PATIENT HAD A FALL AND SUFFERED A FEMUR FRACTURE WHICH WAS FIXED WITH A RETROGRADE NAIL AND SCREWS. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 21345617 ↗
• InjuryJan 7, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO THE TIBIAL COMPONENT BEING LOOSE AT THE CEMENT TO IMPLANT INTERFACE. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 13196917 ↗
• InjurySep 9, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT AND BONE TO CEMENT INTERFACE. DEPUY CEMENT MANUFACTURER WAS USED. X-RAYS SHOW LUCENA UNDER TIBIAL COMPONENT. TRAY FOUND TO BE GROSSLY LOOSE. REVISION TRAY WITH STEM AND SLEEVE PLACED. DOI: (B)(6) 2018; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8976163 ↗
• InjuryJul 13, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  DER STATES THAT THE PATIENT IS EXPERIENCING PAIN. X-RAY INDICATED A LOOSE TIBIAL COMPONENT THAT HAD FALLEN IN TO VARUS. FEMORAL AND TIBIAL PARTS WERE REVISED. TIBIA LOOKED TO BE WELL FIXED EVEN THOUGH ON X-RAY IT LOOKED LOOSE. THERE WAS SIGNIFICANT BONE LOSS MEDIALLY.

  Patient problems: Pain

  MAUDE report 6709913 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K943462, K950010, K952830, K961685, 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-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-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-0391-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-0442.
• 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-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-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-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-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-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.
• 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-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-0386-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 10.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0431.

…and 24 more.