P.F.C. SIGMA 86-6025Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295216803), received between Jun 14, 2018 and Nov 4, 2025 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 reports).

16 other recalls cover devices cleared under the same FDA submission (K241000, 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 23466744 ↗
• InjuryJul 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2024. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO IMPLANT LOOSENING. THE NON-ARTICULAR SURFACE OF THE CEMENTED CC FEMORAL COMPONENT SHOWS MODERATE CEMENT REMAINING. THE NON-ARTICULAR SURFACE OF THE CEMENTED TIBIAL TRAY SHOWS SPARSE CEMENT REMAINING, NO RELATIVE MOTION, EXCELLENT INTERDIGITATION WITH BONE, AND NO IN VIVO DAMAGE. CEMENT MFG IS UNKNOWN. AT REVISION THE TIBIAL INSERT SHOWED CRACKING ON THE RIM.

  Patient problems: Insufficient Information

  MAUDE report 19841392 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER SURGERY ON (B)(6) 2020, PATIENT COMPLAINS OF STIFF JOINT (B)(6) 2021). NO IMPROVEMENT IN JOINT STIFFNESS AFTER MOBILIZATION UNDER ANAESTHESIA (B)(6) 2021). PATIENT COMPLAINS OF SWELLING AFTER A FALL (B)(6) 2022). (B)(6) 2022 INFECTION IS DETECTED. EXPLANATION OF KNEE PROSTHESIS ON (B)(6) 2022 AND IMPLANTATION OF CEMENT SPACER. REVISION OPERATION ON (B)(6)2022.

  Patient problems: Fall; Muscular Rigidity; Swelling/ Edema; Unspecified Infection

  MAUDE report 18411653 ↗
• MalfunctionJan 17, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE DEVICE IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185971 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2004: PATIENT HAD A LEFT KNEE PLACED DUE TO OSTEOARTHRITIS. DEPUY SIGMA IMPLANTS WERE PLACED WITH AN UNKNOWN CEMENT MFG. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. (B)(6) 2021: DOCTOR'S PROGRESS NOTE INDICATES THE PATIENT IS EXPERIENCING PAIN AND DISCOMFORT MEDIALLY AND WITH PATELLAFEMORAL ARTICULATION. SWELLING AND SMALL EFFUSION WERE ALSO NOTED. NO INSTABILITY WERE NOTED. RADIOLOGY NOTES FROM (B)(6) 2021: WEAR ON BOTH KNEES. LEFT KNEE HAS OSTEOLYSIS ANTERIOR AND POSTERIOR PORTION OF THE FEMUR AND PORTIONS AROUND THE POSTERIOR TIBIAL TRAY. THE RIGHT KNEES SHOWS SOME MEDIAL POLYETHYLENE WEAR, BUT NO SIGNIFICANT OSTEOLYSIS. (B)(6) 2022: PATIENT UNDERWENT A LEFT KNEE REVISION FOR FAILURE OF FIXATION. ATTUNE REVISION IMPLANTS WERE PLACED. INTRA-OP FINDINGS INCLUDED GROSS LOOSENING OF THE FEMORAL COMPONENT AND SIGNIFICANT OSTEOLYSIS OF THE PROXIMAL TIBIA. REVISED TIBIAL INSERT DIDN'T SHOW SIGNIFICANT WEAR. FEMORAL COMPONENT HAD FIBROUS FIXATION, BUT THERE WAS NO INDICATION OF THE LOOSENING INTERFACE. ATTUNE REVISION IMPLANTS WERE PLACED. CEMENT MFG IS UNKNOWN. AT THIS TIME THE MANUFACTURER OF THE RIGHT KNEE IS UNKNOWN. ADDITIONAL FOLLOW UP IS BE CONDUCTED TO DETERMINE IF THE M

  Patient problems: Discomfort; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 14462311 ↗
• InjurySep 22, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS EFFUSION, INSTABILITY, SYNOVITIS, FIBROUS TISSUE, TIBIAL BONE LOSS, TIBIAL CYST, OSTEOLYSIS, POLY WEAR INVOLVING THE TIBIAL INSERT AND PATELLA COMPONENT, AND TIBIAL TRAY LOOSENING AT AN UNKNOWN INTERFACE. ALL COMPONENTS WERE REVISED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Insufficient Information; Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 12514137 ↗
• 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 12480693 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO PAIN, OSTEOLYSIS AND LOOSENED FEMORAL COMPONENT. UPON ENTERING THE JOINT, SYNOVITIS AND MCL LAXITY WAS NOTED. THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AT THE CEMENT TO IMPLANT INTERFACE AND CEMENT TO BONE INTERFACE. THE FEMORAL BONE WAS NOTED TO HAVE SIGNIFICANT BONE DEFECTS. ALL COMPONENTS INCLUDING THE PATELLA WERE REVISED. NO INDICATION OF DEFICIENCY RELATED TO THE TIBIAL COMPONENT. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Cyst(s); Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11602342 ↗
• InjuryJun 5, 2019Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  REVISION TKR - PT ORIGINAL TKR (PFC) (B)(6) 2017 4 CEMENTED FEMUR, 4 TIBIA, 10MM CURVED INSERT, 38 PATELLA. TIBIAL TRAY HAS COLLAPSED INTO VARUS - PAIN/LOOSE TIBIA.

  Patient problems: No Code Available; Pain

  MAUDE report 8669889 ↗
• MalfunctionApr 10, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING PROCEDURE THEY REALIZED THAT THE PACKAGING OF THE DEVICE WAS NOT STERILE. THE PRODUCT WAS NOT USED ON PATIENT, THEREFORE THERE IS NO PATIENT CONSEQUENCE.

  Patient problems: Not Applicable

  MAUDE report 8499431 ↗
• InjuryDec 14, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: No Code Available

  MAUDE report 8164103 ↗
• InjuryAug 24, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. BASE PLATE AND POLY BROKE. REMOVED AND REPLACED FEMORAL TIBIAL AND POLY COMPONENTS. DOI: UNKNOWN ; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7812585 ↗
• InjuryJun 26, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POLYWEAR RESULTING IN OSTEOLYSIS OF THE RIGHT FEMUR ZONE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DOI: (B)(6) 2001; DOE: (B)(6) 2018; (RIGHT KNEE). 06/04/2018 CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO OSTEOLYSIS, POLYWEAR, LOOSENING OF ALL COMPONENTS. REVISION OCCURRED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7637141 ↗
• InjuryJun 14, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF TIBIAL TRAY AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: 17 YEARS AGO DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7600995 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, 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-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-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-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-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-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-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-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-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-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-1337-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 3, 17.5 mm; Ref 98-4151.
• 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-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-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-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.

…and 1 more.