P.F.C. SIGMA 96-0660Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295233565), received between Jul 19, 2018 and Sep 15, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

31 other recalls cover devices cleared under the same FDA submission (K241000, K943462, K950010, K961685, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. DEPUY SIGMA KNEE IMPLANTED WITH THREE DEPUY CEMENT PRODUCTS. THE SURGEON NOTED AFTER CEMENTATION OF THE ALL-POLY TIBIA, THERE WAS SOME BLEEDING FROM A LATERAL SIDE OF THE JOINT IN THE LATERAL GUTTER. THE SITE WAS INSPECTED, AND IT WAS FOUND TO BE INFEROLATERAL GENICULATE ARTERY WITH BLEEDING. MULTIPLE ATTEMPTS WERE MADE TO CAUTERIZE THE BLEED, BUT ALTHOUGH THE BLEEDING SLOWED SIGNIFICANTLY THE SURGEON WAS UNABLE TO GET IT COMPLETELY WITH THE KNEE IN EXTENSION OR IN FLEXION. THE SURGEON ELECTED TO EXPLANT THE TIBIAL COMPONENT TO GAIN ACCESS TO THE BLEEDER, SO THE ALL-POLY TIBIAL TRAY WAS REMOVED WITH AN OSCILLATING SAW AND STEM LIFTED OUT OF THE CEMENT MANTLE. THE SURGEON WAS ABLE TO ISOLATE THE ANTEROLATERAL GENICULATE ARTERY, AND THIS WAS CAUTERIZED. THE PREVIOUS CEMENT MANTLE WAS LEFT IN PLACE AND A NEW BATCH OF DEPUY CEMENT WAS USED TO IMPLANT A NEWLY OPENED ALL-POLY TIBIAL COMPONENT. BLOOD LOSS WAS ESTIMATED AT 600 ML DURING THE PROCEDURE. THERE IS NO EVIDENCE OF BLOOD TRANSFUSION NOR INTERVENTION AFTER CAUTERIZATION. DOE: (B)(6) 2013. LEFT KNEE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 10535139 ↗
• MalfunctionMay 10, 2019Naturally Worn; Naturally Worn

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAY - TIBIAL AP LUCENCIES, POLY WEAR : ABNORMAL RADIOGRAPHIC EVALUATION EVENT IS NOT SERIOUS AND IS CONSIDERED MILD EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2009, DOE: (B)(6) 2019, (RIGHT KNEE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601288 ↗
• MalfunctionMay 10, 2019Naturally Worn; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAY - TIBIAL AP LUCENCIES, POLY WEAR : ABNORMAL RADIOGRAPHIC EVALUATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2009. DOE: (B)(6) 2019. (LEFT KNEE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600219 ↗
• InjuryJul 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. UPON SURGICAL EVALUATION, THE FRONT PART OF THE TIBIA LOOKED TO BE A LITTLE LOOSE. ALL POLY TIBIA WAS CONVERTED TO A METAL BACKED TRAY AND STEM. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7704445 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K943462, K950010, K961685, K971189. One submission often covers many models, so check the product and lot details in each record.

• Z-1077-2014 · Dec 9, 2013 · Terminated
  PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
• Z-1686-2009 · May 7, 2009 · Terminated
  DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. The devic
• 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-0403-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 8 mm, 71mm M/L, 47 mm A/P, UHMWPE, sterile; Product Code/ REF 96-0640.
• 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-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-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-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-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-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-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-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-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-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.

…and 16 more.