P.F.C. SIGMA 96-0045Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295232254), received between Nov 7, 2019 and Sep 16, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  TIBIAL AND FEMORAL ASEPTIC LOOSENING AT THE IMPLANT\CEMENT INTERFACE. CEMENT NOT FROM DEPUY. DEVICE REMOVED AND PATIENT EXPERIENCED PAIN. DOR: (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 12480698 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  KNEE REVISION FOR TIBIAL AND FEMORAL LOOSENING, KNEE PAIN AND STIFFNESS OF THE KNEE. LOOSENING AT THE CEMENT/BONE INTERFACE WITH CEMENT NOT FROM DEPUY. SURGICAL TIME WAS NOT EXTENDED. TKA IMPLANTED IN 2008.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 12203802 ↗
• InjuryJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS BEING LOGGED TO CAPTURE PATIENTS 1ST REVISION REPORTED IN (B)(4) - 3RD REVISION TO TREAT PAIN.

  Patient problems: Pain

  MAUDE report 12180000 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS TO CAPTURE PATIENTS¿ PRIOR REVISIONS REPORTED IN (B)(4). THIS WAS THE SEVENTH REVISION FOR THIS PATIENT. PATIENT UNDERWENT A LEFT PRIMARY TOTAL KNEE REPLACEMENT (TKR) ON (B)(6) 2009. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 DUE TO TIBIAL PAIN.

  Patient problems: Pain

  MAUDE report 12168120 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR REVISION WAS TIBIAL LOOSENING APPEARED TO BE APPARENT ON XRAY AND BONE SCANS (AS PER SURGEON). IMPLANTS REMOVED. CEMENT FRAGMENTS AMD OLD BLOOD FOUND WITHIN THE JOINT SPACE. SAMPLES OF SYNOVIUM TAKEN. IMPINGEMENT APPARENT ON THR POSTERIOR OF THE POLY INSERT POST AND ON THE POSTERIOR POLY INSERT ARTICULATING SURFACE. THERE ARE NO IMAGES OR X RAYS AVAILABLE. SURGEON PROVIDED NO SPECIFIC CAUSE FOR REVISION BY THE END IF THE CASE.

  Patient problems: No Code Available

  MAUDE report 9291692 ↗

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

…and 9 more.