P.F.C. SIGMA 1581-03-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295062547), received between Jan 11, 2018 and Feb 4, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K040166, K082500, K241000, K943462); 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.

• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY EXPLANTED DUE TO SUSPECTED INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 24261831 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS PATIENT COMPLAINTS OF STIFFNESS AND PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 13479551 ↗
• MalfunctionMar 23, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT UPON ATTEMPTING TO IMPACT A 3X8 PLI INSERT INTO A SIZE 3 FIXED BEARING SIGMA TIBIA, 2 ISSUES WERE ENCOUNTERED. WHILE TRYING TO IMPACT THE POLY FIRST TIME, THE POLY SAT UP ON THE MEDIAL SIDE, AT WHICH POINT THE INTERFACE WAS INVESTIGATED AND THE DECISION WAS MADE TO EXTRACT THE POLY AND OPEN A NEW 3X8 PLI POLY. WHEN TRYING TO IMPACT THE POLY THE SECOND TIME, IT SAT UP AGAIN, ONLY THIS TIME ON THE LATERAL SIDE. ONCE AGAIN, THE INTERFACE WAS INVESTIGATED AND A DECISION TO EXTRACT THE POLY WAS MADE. THIS TIME A 3X8 CURVED POLY WAS OPENED, AND UPON BEING IMPACTED, THE LOCKING MECHANISM ENGAGED THE POLY. THERE WAS A SURGICAL DELAY OF 5 MINS. DOE: (B)(6) 2020, UNK AFFECTED SIDE.

  Patient problems: Not Applicable

  MAUDE report 9868387 ↗
• MalfunctionMar 23, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT UPON ATTEMPTING TO IMPACT A 3X8 PLI INSERT INTO A SIZE 3 FIXED BEARING SIGMA TIBIA, 2 ISSUES WERE ENCOUNTERED. WHILE TRYING TO IMPACT THE POLY FIRST TIME, THE POLY SAT UP ON THE MEDIAL SIDE, AT WHICH POINT THE INTERFACE WAS INVESTIGATED AND THE DECISION WAS MADE TO EXTRACT THE POLY AND OPEN A NEW 3X8 PLI POLY. WHEN TRYING TO IMPACT THE POLY THE SECOND TIME, IT SAT UP AGAIN, ONLY THIS TIME ON THE LATERAL SIDE. ONCE AGAIN, THE INTERFACE WAS INVESTIGATED AND A DECISION TO EXTRACT THE POLY WAS MADE. THIS TIME A 3X8 CURVED POLY WAS OPENED, AND UPON BEING IMPACTED, THE LOCKING MECHANISM ENGAGED THE POLY. THERE WAS A SURGICAL DELAY OF 5 MINS. DOE: (B)(6) 2020, UNK AFFECTED SIDE.

  Patient problems: Not Applicable

  MAUDE report 9868374 ↗
• MalfunctionNov 5, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT UPON TRYING TO IMPACT THE LINER INTO THE TIBIAL BASE TRAY, THE LINER WOULD NOT SEAT/ ENGAGE THE LOCKING MECHANISM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037144 ↗
• InjuryJan 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE POLY EXCHANGE DUE TO INSTABILITY. EXTRACTED POLY APPEARED TO BE IN GOOD SHAPE. MOVING UP ONE SIZE FROM A 8MM PLI INSERT TO A 10MM CVD PLUS INSERT RESOLVED THE ISSUE TO THE SATISFACTION OF THE SURGEON. DOI: (B)(6)2011 ; DOR: (B)(6) 2017 ; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7181972 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040166, K082500, K241000, K943462. 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-0406-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651.
• 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-0407-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 5, 15mm, 83mm M/L, 55mm A/P, UHMWPE, sterile; Product Code/REF 96-0663.
• Z-0404-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 10mm, 71mm M/L, 47mm A/P, UHMWPE, sterile; Product Code/REF 96-0641.
• Z-0402-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 2.5, 8 mm, 67mm M/L, 45 mm A/P, UHMWPE, 2.5, sterile; Product Code/REF 96-0630.
• Z-0405-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650.