P.F.C. SIGMA 86-4177Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295216391), received between Oct 20, 2017 and Oct 21, 2019 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 reports).

15 other recalls cover devices cleared under the same FDA submission (K952830, K961685); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PRIMARY IMPLANTED ON 2013, PRIMARY SURGEON WAS (B)(6). J&J REP WAS PRESENT AT THE CASE. REASON FOR REVISION GIVEN WAS PAIN AND LOOSENING. EXPLANTS WERE REMOVED. SURGEON STATES HE IS UNSURE OF THE CAUSE OF THE LOOSENING POSSIBLY THE IMPLANT, POSSIBLY THE CEMENT IMPLANT BONE INTERFACE. ATTUNE REVISION IMPLANTS WERE IMPLANTED.

  Patient problems: No Code Available; Pain

  MAUDE report 9215775 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL KNEE FOR STIFFNESS AND LACK OF ROM. KNEE FIXED FLEXION DEFORMITY OF 25 DEGREES. COMPONENTS WELL FIXED AND WELL ALIGNED. PATELLA SKYLINE VIEW WELL POSITIONED. NO OBVIOUS ISSUES TO CAUSE STIFFNESS AS SUCH.

  Patient problems: Joint Disorder; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8815814 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO OSTEOLYSIS, POLY WEAR AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. IT WAS ALSO REPORTED THAT THE PATIENT IS ALLERGIC TO NICKEL. DOI: (B)(6) 2004. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 8692532 ↗
• InjuryFeb 19, 2019Migration; Migration

  PATIENT REQUIRED A REVISION SURGERY AS THE TIBIAL COMPONENT HAD SUBSIDED.

  Patient problems: No Code Available

  MAUDE report 8349758 ↗
• InjuryOct 31, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8025253 ↗
• InjuryOct 11, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PRIMARY SURGERY WAS PERFORMED 18 YEARS AGO (DATE OF PRIMARY SURGERY WAS UNKNOWN). IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED TO BE PERFORMED BY REPLACING IMPLANTS (P/NS AND LOT NUMBERS WERE UNKNOWN) FROM THE PATIENT¿S KNEE JOINT DUE TO LOOSENING ON (B)(6) 2018.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 7955954 ↗
• InjuryAug 21, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. NO FALLS OR TRAUMA. REPLACED WITH STEMMED/SLEEVED MBT TRAY. DOI: (B)(6) 2003; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7801290 ↗
• InjuryOct 20, 2017Loss of or Failure to Bond; Appropriate Device Problem Term/Code Not Available; Loss of or Failure to Bond; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FIXED-BEARING TIBIAL BASE PLATE AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. THERE WAS ALSO SOME PITTING OF THE TIBIAL BASEPLATE.

  Patient problems: No Information

  MAUDE report 6964601 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K952830, K961685. 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-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-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-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-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-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-0057-2007 · Sep 14, 2006 · Terminated
  Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
• Z-1319-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 10.0 Ref 97-0371.
• Z-1320-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 15.0 mm; Ref 97-0373.
• Z-1315-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 97-0340.
• Z-1318-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361.
• Z-1316-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352.
• Z-1317-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353.
• Z-1369-04 · Dec 22, 2003 · Terminated
  P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703