P.F.C. SIGMA 96-0044Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295232247), received between Sep 5, 2017 and Oct 8, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THE PATIENT EXPERIENCED LEFT SIDE PFC SIGMA LOOSENING. IT IS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCE DUE TO THE REPORTED EVENT. THERE WAS NO SURGICAL DELAY OR MEDICAL INTERVENTION. IT WAS NOTED THERE IS NO INFECTION.

  Patient problems: Insufficient Information

  MAUDE report 20397388 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WITH NO PATELLA BECAME UNSTABLE AND DISLOCATED HER SIGMA C/S R/P STABILIZED INSERT. SHE WAS REVISED TO AN S-ROM HINGE FEMORAL COMPONENT AND HINGED INSERT. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11853228 ↗
• InjuryNov 10, 2020Unintended Movement; Unintended Movement

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS ASEPTIC LOOSENING DATE OF IMPLANTATION: (B)(6) 2002. DATE OF REVISION: (B)(6) 2020. (LEFT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, AND TIBIAL INSERT WERE REVISED; PATELLA RETAINED. UPDATE: MEDICAL RECORDS RECEIVED AD 21 OCT 2020 WERE REVIEWED ON 27 OCT 2020 BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. PRIMARY OPERATIVE NOTES (B)(6) 2002 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATES THE PATIENT RECEIVED AN ADDITIONAL LEFT TOTAL KNEE REVISION DUE TO SIGNIFICANT POLYETHYLENE WEAR AND VARUS COLLAPSE OF THE KNEE, PAIN AND DECREASED FUNCTION. THE INSERT WAS REMOVED AND INDICATED TO HAVE SIGNIFICANT WEAR. THE TIBIAL AND FEMORAL COMPONENTS WERE NOTED TO BE WELL FIXED BUT ALSO REVISED. SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

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

  MAUDE report 10817197 ↗
• InjuryMay 14, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2005, PRIMARY TIBIA AND PATELLA. DOR: (B)(6) 2010, REVISION FEMUR AND INSERT. DOE: (B)(6) 2019. (LEFT KNEE).

  Patient problems: No Code Available

  MAUDE report 8607854 ↗
• InjuryOct 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN. PATIENT HAS REPORTED BEING UNABLE TO WALK FOR MORE THAN 50 METERS BEFORE NEEDING TO REST THEIR KNEE, DUE TO PAIN. IT WAS ALSO REPORTED THAT ON EXAMINATION IT APPEARS THAT THE KNEE IS IMBALANCED WITH THE LATERAL SIDE OPENING UP TO 7MM IN EXTENSION AND 4 MM IN FLEXION AND THE PATELLA WAS OVERHANGING ON THE MEDIAL SIDE AND APPEARED UNDERSIZED.

  Patient problems: Pain

  MAUDE report 6954598 ↗
• InjurySep 5, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND ASEPTIC LOOSENING OF THE FEMORAL AND TIBIA AT THE UNKNOWN INTERFACE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 6843041 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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.

…and 9 more.