P.F.C. SIGMA 96-0058Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295232445), received between Nov 2, 2017 and Sep 6, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2023Migration; Migration

  CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING LEFT REVISION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2002. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: NONE.

  Patient problems: Insufficient Information

  MAUDE report 17691958 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. NO ADDITIONAL INFORMATION AVAILABLE. DOI: (B)(6) 2007. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8357632 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2006; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7655153 ↗
• InjuryNov 30, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  DER STATES THAT PATIENT WAS CLAIMING OF PAIN AND THE SURGEON WAS CONCERNED WITH BONE GROWTH AROUND PATELLA AS WELL AS POSSIBLE LOOSENING OF FEMORAL COMPONENT. DURING SURGERY BOTH TIBIAL AND FEMORAL COMPONENTS WERE LOOSE. CEMENT WAS FOUND BOTH ON IMPLANTS AND BONE. PATELLA WAS ALSO RESURFACED AND IMPLANT REPLACED.

  Patient problems: Pain

  MAUDE report 7072603 ↗
• InjuryNov 2, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS SUBSIDENCE OF THE TIBIA AND LOOSENING OF THE TIBIA AND FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE, CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 6998332 ↗

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-0388-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 15.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0433.
• 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-0393-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 12.5 mm, 4, UHMWPE, sterile; Product Code/REF 96-0452.
• 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-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-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.
• 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-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-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-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-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.

…and 9 more.