P.F.C. SIGMA 86-6029Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295216834), received between May 15, 2018 and Aug 6, 2026 — classified as 18 injuries, 2 malfunctions.

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

24 other recalls cover devices cleared under the same FDA submission (K241000, K884796, K952830); 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. 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 instability and pain.

  Patient problems: Joint Laxity; Pain

  MAUDE report 50161777 ↗
• InjuryNov 4, 2025Loss 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 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 LOOSE FEMORAL COMPONENT, LOOSE TIBIAL COMPONENT, INSTABILITY, AND PAIN. THE TIBIAL INSERT SHOWED MODERATE YELLOWING. THE NON-ARTICULAR SURFACE OF THE CEMENTED CC FEMORAL COMPONENT SHOWS ABUNDANT CEMENT REMAINING. THE NON-ARTICULAR SURFACE OF THE CEMENTED TIBIAL TRAY SHOWS A MODERATE RETRIEVAL ARTIFACT, AND NO CEMENT REMAINING. UNKNOWN CEMENT MFG.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23468420 ↗
• InjuryMar 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 18977578 ↗
• InjuryApr 28, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT AND IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2000. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16832901 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 2008 IMPLANTED SIGMA PFC KNEE PROSTHESIS HAD TO BE REVISED, DUE TO PAIN. THERE WAS SOME "METALLOSE" IN THE KNEE JOINT. IT WAS REPLACED WITH AN ATTUNE REVISION PROSTHESIS. DOI: 2008, DOR: (B)(6) 2023, UNKNOWN KNEE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 16712607 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNDISCOVERED NICKEL ALLERGY AND THIS HAD PAIN WHEN THE ORIGINAL CONSTRUCT WAS PUT IN. SURGEON TOOK IT ALL OUT AND PUT IN A COMPETITOR REVISION CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16233205 ↗
• MalfunctionJul 20, 2022Difficult to Insert; Difficult to Insert

  UPON IMPLANTATION, TIBIAL INSERT WAS NOT COMPLETELY FLUSH LATERALLY LEAVING SPACE BETWEEN THE TIBIAL TRAY AND THE INSERT. OPERATED KNEE IS RIGHT. SURGEON DECIDED TO CHANGE INSERT SIZE TO 10MM BUT SAME ISSUE WAS OBSERVED. FINAL DECISION WAS TO IMPLANT SIZE 10 EVEN WITH THE PROBLEM INVOLVED. FEAR OF INSERT DISLOCATION AND BACKSIDE WEAR REMAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065636 ↗
• InjuryDec 7, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION TO TREAT TIBIAL ASEPTIC LOOSENING AT THE BONE/CEMENT INTERFACE MEDIALLY AND AT THE CEMENT/IMPLANT EXTERNALLY. NOT CEMENT FROM DEPUY. DOR: (B)(6) 2021, RIGHT KNEE, DID THE PATIENT EXPERIENCE A POST-OP DEVICE.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 12950499 ↗
• InjuryMar 10, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  LEFT KNEE REVISION DUE TO TIBIAL LOOSENING. PFC SIGMA IMPLANTED (B)(6) 2019, LEFT KNEE PAIN.

  Patient problems: Pain

  MAUDE report 11454185 ↗
• InjuryJan 15, 2021Loss of or Failure to Bond

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT AND BONE TO CEMENT INTERFACES. CR SIGMA KNEE IMPLANTED APPROXIMATELY 18 YEARS AGO. THE FEMUR AND PATELLA WERE FINE AND REMAINED. NO SURGICAL DELAY. CEMENT MANUFACTURER UNKNOWN. DOI: (B)(6) 2002, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11178034 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS WERE REVISED TODAY, REASON FOR REVISION WAS DUE TO FAILURE OF THE PATIENTS ANATOMY.

  Patient problems: No Code Available; Pain

  MAUDE report 9616388 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TIBIAL TRAY REVISION:THE PATIENT UNDERWENT PRIMARY TKR SURGERY APPROXIMATELY 12 YEARS AGO, WHERE A PFC CR FEMUR AND FIXED BEARING TIBIA WITH STEM WAS UTILISED. SURGEON UNKNOWN, DATE UNKNOWN AND PRODUCTS AND CODE UNKNOWN. THE PATIENT HAS PRESENTED INDICATING THAT SHE HAS EXPERIENCED PAIN AROUND THE SHIN FOR APPROXIMATELY 1 YEAR (TIBIAL PAIN). BONE SCANS INDICATE A HOT AREA AROUND THE TIP OF THE STEM AND U DR THE TIBIAL TRAY ON THE MEDIAL SIDE OF THE TIBIA. A DECISION WAS MADE TO REVISE THE TIBIA AND MAKE USE OF A SLEEVED TIBIAL TRAY WITH STEM. ON OPENING THE KNEE, THE FEMORAL COMPONENT WAS FOUND TO BE WELL FIXED. THE TIBIAL COMPLEMENT DID NOT APPEAR OVERTLY LOOSE BUT DID COME OUT WITH. NO AE REPORTED, NO DELAY IN THE SURGERY.

  Patient problems: No Code Available; Pain

  MAUDE report 9519721 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL COAGULATION FUNCTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT: (B)(6) 2019, (LEFT KNEE). ABNORMAL COAGULATION FUNCTION- ON (B)(6) 2019, THE PATIENT RETURNED TO THE HOSPITAL FOR VISIT 6. AFTER BLOOD COAGULATION EXAMINATION, THE APTT WAS 18.9S AND REPORTED AS A RISK VALUE. THE IT WAS JUDGED AS CS BY THE INVESTIGATOR. THE PATIENT WAS SUGGESTED OF OUT-PATIENT TREATMENT AT HEMATOLOGY DEPARTMENT, AND THE AE SHOULD BE CHECKED.

  Patient problems: Blood Loss

  MAUDE report 8894987 ↗
• MalfunctionJun 19, 2019Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2019, THE INSERT (P/N: 158122008) DIDN¿T FIT WITH AN UNKNOWN TIBIAL TRAY (P/N: UNKNOWN). ANOTHER INSERT WHICH WAS PREPARED FOR THE OPPOSITE SIDE WAS USED INSTEAD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714660 ↗
• InjuryMay 14, 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. UNKNOWN CEMENT WAS USED. IT WAS ALSO REPORTED THAT THERE WAS MASSIVE METAPHYSEAL BONE LOSS IN THE PROXIMAL TIBIA. TREATED WITH TC3 RP REPLACEMENT WITH TIBIAL SLEEVE AND STEM. SIGNIFICANT PROX TIBIA BONE GRAFTING WAS DONE. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Injury; No Code Available

  MAUDE report 8607623 ↗
• InjuryJan 14, 2019Corroded; Degraded; Adverse Event Without Identified Device or Use Problem; Corroded; Degraded; Adverse Event Without Identified Device or Use Problem

  THE REVISION SURGERY WAS DONE BECAUSE THE KNEE WAS NOT FOLDING AND WAS HAVING LOT OF PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8243996 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVISION SURGERY WAS DONE BECAUSE THE KNEE WAS NOT FOLDING AND WAS HAVING LOT OF PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8240218 ↗
• InjurySep 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL NOTIFICATION RECEIVED FOR REVISION RELATED TO PAIN AND STIFFNESS. DOI: (B)(6) 2001; DOR: (B)(6) 2018; (RIGHT KNEE).

  Patient problems: Not Applicable; Pain

  MAUDE report 7859593 ↗
• InjuryAug 9, 2018Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT USED WAS COMPETITOR. PATIENT HAD PRIMARY LEFT KNEE DONE IN 2003. PATIENT HAD A CR SIGMA AND FB TRAY, CR INSERT AND PATELLA IMPLANTED THEN ON (B)(6) 2018 SURGEON DETERMINED CR FEMUR WELL FIXED AND WELL POSITIONED. SURGEON REMOVED MBT REVISION TRAY AND CVDRP IMPLANTED. PATELLA AND FEMUR LEFT IN PLACE. DOI: 2003, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7766899 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENTS UNDERGOING TOTAL KNEE ARTHROPLASTY SURGERY, POSTOPERATIVE SECONDARY TO PAIN. SURGERY-RELATED, MEDICATION AND PHYSICAL THERAPY, IMPROVED. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7514036 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K884796, K952830. 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-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-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-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-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-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-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-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-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-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.

…and 9 more.