P.F.C. SIGMA 96-0053Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295232360), received between Dec 15, 2017 and Feb 22, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL KNEE REPLACEMENT FOR LOOSENING AND INSTABILITY. PFC SIGMA PS FB TKR. NO IMPLANT DETAILS ARE AVAILABLE DUE TO RECORDS BE UNAVAILABLE DUE TO TIMEFRAME. THE ENTIRE TIBIAL COMPONENT WAS AFFECTED, NOT ONE PARTICULAR SIDE. THE KNEE WAS 20 YEARS OLD IT WAS HARD TO DETERMINE WHAT INTERFACE WAS INVOLVED. THIS WAS ASSOCIATED WITH BONE SUBSIDENCE AND COLLATERAL LIGAMENT INSTABILITY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity

  MAUDE report 11358118 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPONENTS ARE NOW REPORTABLE DUE TO PAIN AND THE LIMITED MOBILITY AS REASON FOR THE REVISION.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10126867 ↗
• InjuryFeb 25, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  SURGEON REPORTED THAT A PATIENT, WHO HAS A TOTAL KNEE IMPLANTED 15 YEARS AGO, EXPERIENCED SOME ANTERIOR KNEE PAIN, CLUNKING RELATED TO POSSIBLE PATELLA ISSUES. THE PATIENT ALSO REPORTED THAT THERE WAS AN INFLAMMATION. HE PERFORMED A REVISION, WHERE IT WAS DISCOVERED THAT THE PATELLA HAD SOME WEAR AND HAD BECOME MISSHAPEN. THE PATELLA HAD A GROOVE WORKED INTO IT. IT COULD HAVE BEEN FROM A FALL, ACCORDING TO THE SURGEON. OTHERWISE, THE REST OF THE TOTAL KNEE LOOKED GOOD. HE REPLACED THE LINER, CHECKED THAT ALL THE COMPONENTS WERE WELL FIXED AND REPLACED THE PATELLA BUTTON WITH A NEW ONE. ORIGINAL SURGERY WAS (B)(6) 2005.

  Patient problems: Inflammation; No Code Available; Pain

  MAUDE report 9750827 ↗
• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN UNSTABLE AND PAINFUL KNEE. THE ORIGINAL CASE WAS DONE 11 YEARS AGO BY THE SURGEON. DOI: (B)(6) 2008; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9081787 ↗
• InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8146033 ↗
• InjuryDec 15, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2004. DOR: (B)(6) 2017. RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7120662 ↗

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-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-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-0420-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, 4, UHMWPE, sterile; Product Code/REF 96-2652.
• 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-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-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-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-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-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-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-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-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.

…and 9 more.