P.F.C. SIGMA 96-0054Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295232384), received between Aug 29, 2017 and Mar 4, 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.

• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HCP SENT A MEDICAL INFO REQUEST TO TEAM: "I HAVE A PATIENT IN THE CLINIC WHO HAS DEVELOPED SYMPTOMS SINCE SEVERAL WEEKS AFTER IMPLANTATION OF A PFC MODULAR PLUS PROSTHESIS. SURGICAL DATE (B)(6) 2008: PFC MODULAR RIGHT KNEE: FEMUR CEMENTED, SIZE 4, TIBIA CEMENTED, SIZE 3, PLATEAU HEIGHT 10 MM STABILIZED; PATELLUM SHAPING. THE PATIENT NOW PRESENTS AND THE IMAGES SHOW THE INLAY AS WORN/DEFECTIVE WITH A DEFECT ON THE DORSAL MEDIAL TIBIAL CONSOLE AND VENTRAL SUBLUXATION OF THE TIBIA TO THE FEMUR. IT IS CLEAR THAT THERE WILL BE A CERTAIN AMOUNT OF METALLOSIS WITH A DORSALLY RUBBED TIBIAL COMPONENT. AS THE MANUFACTURER, IS IT STILL PERMISSIBLE TO CHANGE THE INLAY ALONE IN THE CASE OF A DORSALLY IMPAIRED TIBIAL COMPONENT?".

  Patient problems: Foreign Body Reaction; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18825866 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. HE HAD HIS KNEE REPLACED SOME TIME AGO BY ANOTHER SURGEON AND HAS HAD 6 REVISION SURGERIES AFTER HIS ORIGINAL TKA. THE ORIGINAL IMPLANT DATE IS UNKNOWN. IT WAS REPORTED THAT THE SURGEON DOES NOT KNOW THE SPECIFICS ON WHAT SURGEON REVISED THE PATIENT'S KNEE OR EXACTLY WHEN THE REVISIONS TOOK PLACE. THE PATIENT CAME IN TO SEE THE SURGEON FOR INSTABILITY AND THE DECISION WAS MADE BY THE SURGEON AND THE PATIENT TO REVISE THE KNEE. DURING THE REVISION, THE SIGMA SZ 4 PS FEMUR AND SZ 4 X 22.5 RP INSERT WERE EXPLANTED. THE PATELLA AND THE TIBIAL TRAY WERE LEFT IN SITU. A NEW FEMORAL COMPONENT WITH STEM, AUGMENTS AND SLEEVE WERE IMPLANTED ALONG WITH A NEW BEARING. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11818925 ↗
• InjuryJul 29, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  CLINICAL NOTIFICATION RECEIVED FOR RIGHT KNEE REVISION TO ADDRESS ASEPTIC LOOSENING. DOI: (B)(6) 2006. DOR: 06/04/2019. (RIGHT KNEE). FEMUR, TIBIAL TRAY, AND TIBIAL INSERT WERE REVISED.

  Patient problems: No Code Available

  MAUDE report 8835652 ↗
• InjuryOct 11, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS DEPUY. DOI: (B)(6) 2005; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 7956474 ↗
• InjuryNov 2, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIA AND FEMORAL COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE, COMPETITOR CEMENT WAS USED.

  Patient problems: No Code Available

  MAUDE report 6998452 ↗
• InjuryAug 29, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND FEMUR LOOSENING. LOOSENING OCCURRED FROM CEMENT TO IMPLANT INTERFACE. CEMENT IS OF COMPETITOR.

  Patient problems: Pain

  MAUDE report 6827594 ↗

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

…and 9 more.