P.F.C. SIGMA 86-6024Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295216797), received between Sep 5, 2017 and Jun 30, 2025 — classified as 21 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 reports).

16 other recalls cover devices cleared under the same FDA submission (K241000, K882234, K884796); 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT POLY WOULD NOT SNAP INTO TRAY. SURGEON OPENED TWO SIZE 4-8 POLY AND TWO SIZE 4 TRAYS AND BOTH POLY WOULD NOT SNAP INTO TO THE TRAY THAT WAS IMPLANTED AND THE EXTRA TRAY. DOE: JUNE 11, 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359598 ↗
• MalfunctionFeb 28, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THREADED TIP APPEARS STRIPPED.. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453507 ↗
• MalfunctionFeb 9, 2023Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  IMPLANT BOX APPEARS MELTED AND STUCK AS NURSE WAS TRYING TO GRAB IT FROM THE BOX. THERE WAS A SURGICAL DELAY OF ONE MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16333440 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. IMPLANTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16246219 ↗
• MalfunctionApr 13, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT 1, BOX HAIR FOUND INSIDE THE SHRINK-WRAP COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14101477 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR PATELLA RESURFACING. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT: (B)(6), WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: PAIN, DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF YES, DATE OF REVISION SURGERY. (B)(6) 2021, REASON FOR REVISION SURGERY: PAIN.

  Patient problems: Pain

  MAUDE report 13011427 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT HAS PAINFUL AND INFECTED RIGHT KNEE IMPLANTED 8 YEARS AGO. PRIMARY SURGEON UNKNOWN. DR. WILSON REMOVED PFC SIGMA FEMUR, POLY, TIBIAL BASEPLATE, AND PATELLA COMPONENTS FOR FIRST STAGE REVISION. DOI: 8 YEARS AGO, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12680945 ↗
• InjuryJul 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2002 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12217226 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALL IMPLANTS REMOVED AND SPACER PLACED TO TREAT INFECTION. DOI: (B)(6) 2019, DOR: UNKNOWN, INFECTED LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11691386 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION DUE TO PAIN, LIMPING, PATIENT WAS SCREENED FOR INFECTION PRIOR TO REVISION.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11649960 ↗
• InjurySep 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT REVISION OPERATIVE NOTES (B)(6) 2013 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO LOOSE AND PAINFUL RIGHT TOTAL KNEE. UPON ENTERING THE JOINT, METAL STAINED FLUID WAS ENCOUNTERED, SYNOVIUM SHOWED SEVERE METAL STAINING. SCAR TISSUE WAS DEBRIDED. THE TIBIAL INSERT WAS NOTED TO HAVE SLIGHT WEAR. THE TIBIAL AND FEMORAL COMPONENTS WERE STATED TO BE LOOSE, INTERFACE NOT PROVIDED. THE PATELLA WAS ALSO NOTED TO HAVE MINIMAL WEAR, IT WAS NOT REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. PRODUCTS IMPLANTED AT THIS REVISION ARE LOCATED ON PAGE 13-15. DOI: (B)(6) 2004 DOR: (B)(6) 2013 RIGHT KNEE.

  Patient problems: Adhesion(s); Foreign Body Reaction; No Code Available; Pain

  MAUDE report 10542288 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS POLYETHYLENE WEAR AND INSTABILITY. DATE OF IMPLANTATION: (B)(6) 1999, DATE OF REVISION: (B)(6) 2019, (RIGHT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, AND TIBIAL INSERT WERE REVISED.

  Patient problems: No Code Available

  MAUDE report 9851311 ↗
• InjuryMar 3, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  MEDICAL RECORDS RECEIVED ON AD 27 FEB 2020 WERE REVIEWED ON AD 02 MARCH 2020 BY A CLINICIAN TO IDENTIFY PRODUCT ISSUES AND/OR PATIENT HARMS. PATIENT RECEIVED LEFT PRIMARY PFC SIGMA TKA TO TREAT DEGENERATIVE JOINT DISEASE OF THE LEFT KNEE. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED COMPLICATIONS. PRIMARY IMPLANT STICKER SHEET IS AVAILABLE ON PAGE 11 OF THE MEDICAL RECORDS. ON (B)(6) 2014, THE PATIENT SENT A LETTER TO DEPUY WITH COMPLAINTS OF A ¿SNAPPING¿ IN THE KNEE JOINT WHEN MOVING. ON (B)(6) 2020, THE PATIENT SENT A LETTER TO DEPUY WITH COMPLAINTS OF PAIN, EMOTIONAL DISTRESS, AND, ¿BEING RESTRICTED IN WHAT AND HOW¿ HE COULD ACCOMPLISH DAILY TASKS. RECORDS INDICATE THE PATIENT WAS REVISED DUE TO PAIN. UPON ENTERING THE KNEE, THE SURGEON IDENTIFIED AND EXCISED PERICAPSULAR SCAR TISSUE BEFORE REMOVING THE TIBIAL INSERT. THE FEMORAL COMPONENT, PATELLA, AND TIBIA WERE ALL REVISED DUE TO LOOSENING AT AN UNKNOWN INTERFACE. THE PATIENT WAS THEN IMPLANTED WITH DEPUY REVISION KNEE COMPONENTS UTILIZING UNKNOWN CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9780284 ↗
• InjuryFeb 27, 2020Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

  MEDICAL RECORDS RECEIVED WERE REVIEWED BY A CLINICIAN TO IDENTIFY PRODUCT ISSUES AND/OR PATIENT HARMS. PATIENT RECEIVED LEFT PRIMARY PFC SIGMA TKA TO TREAT DEGENERATIVE JOINT DISEASE OF THE LEFT KNEE. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED COMPLICATIONS. PRIMARY IMPLANT STICKER SHEET IS AVAILABLE ON PAGE 11 OF THE MEDICAL RECORDS. ON (B)(6) 2014, THE PATIENT SENT A LETTER TO DEPUY WITH COMPLAINTS OF A ¿SNAPPING¿ IN THE KNEE JOINT WHEN MOVING. ON (B)(6) 2020, THE PATIENT SENT A LETTER TO DEPUY WITH COMPLAINTS OF PAIN, EMOTIONAL DISTRESS, AND, ¿BEING RESTRICTED IN WHAT AND HOW¿ HE COULD ACCOMPLISH DAILY TASKS. RECORDS INDICATE THE PATIENT WAS REVISED DUE TO PAIN. UPON ENTERING THE KNEE, THE SURGEON IDENTIFIED AND EXCISED PERICAPSULAR SCAR TISSUE BEFORE REMOVING THE TIBIAL INSERT. THE FEMORAL COMPONENT, PATELLA, AND TIBIA WERE ALL REVISED DUE TO LOOSENING AT AN UNKNOWN INTERFACE. THE PATIENT WAS THEN IMPLANTED WITH DEPUY REVISION KNEE COMPONENTS UTILIZING UNKNOWN CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014, DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: Adhesion(s); Fall; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9767461 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. STATIC SPACES USED. NO OTHER INFORMATION WAS AVAILABLE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9718953 ↗
• InjuryMay 20, 2019Loss of or Failure to Bond; Malposition of Device; Loss of or Failure to Bond; Malposition of Device

  (B)(6). DOTS. CLINICAL NOTIFICATION RECEIVED FOR THE RIGHT KNEE REVISION THAT OCCURRED ON (B)(6) 2017, FOR ASEPTIC TIBIAL TRAY IMPLANT LOOSENING. RIGHT KNEE REVISION FOR FAILED FIXATION. ASEPTIC TIBIAL TRAY LOOSENING AT THE IMPLANT TO CEMENT INTERFACE, OSTEOMYELITIS, OSTEOLYSIS.

  Patient problems: No Code Available; Osteolysis; Pain; Swelling; Unspecified Infection

  MAUDE report 8623269 ↗
• InjuryMay 8, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8592903 ↗
• InjuryAug 24, 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. CEMENT USED WAS FROM DEPUY. DOI: (B)(6) 2004, DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7812444 ↗
• InjuryAug 21, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7801152 ↗
• InjuryMay 10, 2018Break; Break

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE, CEMENT MANUFACTURER IS UNKNOWN. DOI : (B)(6) 2017; DOI OF THE STEM: UNKNOWN. DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7502159 ↗
• InjuryJan 10, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  IN 2003 THE PATIENT RECEIVED BILATERAL DEPUY SIGMA TOTAL KNEE REPLACEMENTS. (B)(6) 2014 THE PATIENT WAS ADVISED BY HIS SURGEON THAT THE PFC SIGMA TOTAL KNEE REPLACEMENT SYSTEM WAS ¿CEMENTING.¿ ON (B)(6) 2014 THE PATIENT HAD A REVISION SURGERY. AT THIS TIME, IT IS UNCLEAR WHAT THE REASON FOR REVISION OR PATIENT HARM IS. IT IS ALSO UNCLEAR IF BOTH TOTAL KNEES HAVE BEEN REVISED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS WILL BE RE-ADDRESSED. UPDATE DEC 12, 2017 AND DEC 18, 2017 MEDICAL RECORDS REVIEWED. REVISION NOTES ON (B)(6) 2014 FOR THE RIGHT KNEE INDICATED THE PRESENCE OF SEVERE, GRADE III RETROFEMORAL OSTEOLYSIS INVOLVING THE DISTAL FEMUR BENEATH THE FEMORAL COMPONENT. ADDITIONALLY, IT WAS IDENTIFIED THAT THE TIBIA COMPONENT WAS LOOSE AT THE IMPLANT TO CEMENT INTERFACE. IT WAS NOTED THAT THE PATELLA COMPONENT WAS WELL-FIXED AND NOT REVISED. TIBIA, INSERT, AND PATELLA COMPONENTS ADDED AND REPORTED. COMPLAINT UPDATED ON: JAN 10, 2018.

  Patient problems: Ambulation or Postural Difficulties; Osteolysis

  MAUDE report 7179795 ↗
• InjuryDec 18, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE FOLLOWING IMPLANTS WERE REMOVED BY SURGEON DURING REVISION SURGERY DUE TO POLYETHYLENE WEAR AND TIBIAL AND FEMORAL LOOSENING SIZE 4 TIBIA. 866024, LOT 2063687; SIZE 4 LEFT CR FEMUR 960004, LOT UNREADABLE SIZE 4 8MM PLI INSERT 158104008?, LOT 2048223 ORIGINAL SURGERY APPROXIMATELY 11 YEARS AGO. NO REPORT IS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7124969 ↗
• InjuryDec 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS LOOSE TIBIA AT AN UNKNOWN INTERFACE, CEMENT MANUFACTURER IS UNKNOWN. IT WAS ALSO STATED THAT AN MBT REVISION TRAY 4X15 AND A 15MMX5 CUDRP POLY WAS REIMPLANTED FOR STABILITY. DOI: 1997; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7121055 ↗
• InjuryNov 16, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT UNKNOWN INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7039050 ↗
• InjurySep 5, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND ASEPTIC LOOSENING OF THE FEMORAL AND TIBIA AT THE UNKNOWN INTERFACE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 6842763 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K882234, K884796. One submission often covers many models, so check the product and lot details in each record.

• Z-3099-2011 · Jun 28, 2011 · Terminated
  PFC Sigma Round Dome Patella 38 MM 3 Peg Device is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacryla
• Z-1346-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 15.0 mm; Ref 98-4626.
• Z-1336-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 8.0 mm; Ref 98-4152.
• Z-1343-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 4, 12.5 mm; Ref 98-4618.
• Z-1338-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 12.5 mm; Ref 98-4154.
• Z-1345-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 8.0 mm; Ref 98-4623.
• Z-1341-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 6, 15.0 mm; Ref 98-4198.
• Z-1333-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 12.5 mm; Ref 98-4144.
• Z-1342-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 3, 12.5 mm; Ref 98-4610.
• Z-1335-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 8.0 mm; Ref 98-4142.
• Z-1334-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 10.0 mm; Ref 98-4143.
• Z-1332-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 1, 10.0 mm; Ref 98-4031.
• Z-1344-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 10.0 mm; Ref 98-4624.
• Z-1340-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 5, 8.0 mm; Ref 98-4157.
• Z-1339-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 5, 10.0 mm; Ref 98-4158.

…and 1 more.