P.F.C. SIGMA 86-6402Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295216902), received between Aug 13, 2018 and Dec 30, 2025 — classified as 30 injuries.

The most frequently reported specific device problem is “Fracture” (4 reports).

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 30 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 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 FOR Q4 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR LOOSENING AND PAIN. METAL WEAR NOTED AROUND THE REVISED FEMORAL BOX WITH SIGNIFICANT ABRASIVE WEAR WITHIN THE FEMORAL BOX. THE CENTRAL BOLT IS BROKEN AND COMPLETELY DISPLACED.

  Patient problems: Pain

  MAUDE report 23926479 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND EXCHANGED FOR A COMPONENT AND TIBIA. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23622541 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO INFECTION, THE HING SYSTEM WAS REMOVED ENTIRELY. THERE WAS NO ASEPTIC LOOSENING AND THE SYSTEM WAS WELL FIXED. AFTER REMOVING THE HINGE PIN AND POLYETHYLENE LINER THEY DISIMPACTED THE FEMORAL COMPONENT AND DISRUPTED THE TAPER ENGAGEMENT, LEAVING THE SLEEVE AND STEM BEHIND. AFTER REMOVING THE FEMUR, THEY WORKED TO REMOVE FEMORAL SLEEVE AND DISTAL STEM AND MANAGED TO WITHOUT SUBSTANTIAL BONE LOSS. AFTER REMOVING THE FEMORAL COMPONENT, THEY RESECTED BELOW THE TIBIAL COMPONENT AND KNOCKED IT LOOSE, REMOVING THE ENTIRE CONSTRUCT. AFTER THOROUGHLY WASHING OUT THE JOINT THEY PLACED A CEMENT SPACER TO LET THE INFECTION SUBSIDE. THE CASE TOOK APPROXIMATELY 90 MINUTES AND THERE WAS NO HARM DONE TO THE PT. ALL AVAILABLE INFORMATION WAS DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23001213 ↗
• InjuryApr 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE STEM FROM A PREVIOUS DISTAL FEMUR REPLACEMENT BROKE. REVISION DFR WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 21880928 ↗
• InjuryMar 6, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY, REQUIRING EXTENSIVE DEBRIDEMENT. EXTENSIVE BONE EROSION WAS NOTED ON THE MEDIAL AND LATERAL FEMORAL CONDYLES AS WELL AS ALONG THE MEDIAL TIBIAL PLATEAU REQUIRING BONE GRAFTING TO CORRECT. GRANULATION TISSUE INDICATIVE OF LOOSENING WAS NOTED. THE FEMORAL AND TIBIAL SIDES WERE NOTED TO BE LOOSE - INTERFACE NOT IDENTIFIED. THE PATELLA WAS REMOVED AND UNDERNEATH SMALL CYSTS WERE IDENTIFIED AND REMOVED BEFORE REPLACING. A FRACTURE OF THE FEMORAL STEM AND THE CONNECTING SCREW OCCURRED WITHOUT TRAUMA. THE CONNECTING SCREW BETWEEN THE FEMORAL SHIELD AND THE FEMORAL SHAFT IS AFFECTED. THE REVISION WENT SMOOTHLY.

  Patient problems: Bone Notching; Pocket Erosion; Unspecified Tissue Injury

  MAUDE report 21536913 ↗
• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY RELATED TO THE EVENT.

  Patient problems: Pain

  MAUDE report 20773836 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2020. DOR- (B)(6) 2023. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18144510 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE CLEANING AND RE-REVISION SURGERY AFTER THE CONFIRMATION OF INFECTION. THIS PC REPORTS THE PAIN AND INFECTION AFTER THE REVISION SURGERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED. IT IS ALSO UNKNOWN WHETHER THE IMPLANTS USED IN THE PRIMARY SURGERY ARE JJ PRODUCTS OR NOT. ON (B)(6)2022, THE REVISION SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. THE REASON FOR THE REVISION IS UNKNOWN. AFTER THE REVISION SURGERY, ON (B)(4)2023, THE PATIENT CAME TO THE HOSPITAL COMPLAINING OF THE SUDDEN KNEE PAIN, AND THE INFECTION WAS CONFIRMED. NO FURTHER INFORMATION IS AVAILABLE. DOI; FEB 9, 2022 DOR: MAY 21, 2023 AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17116856 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO KNEE PAIN AND INSTABILITY. UPON TAKING AN X-RAY, IT WAS SHOWN THAT THE NEUTRAL ADAPTER BOLT HAD BROKEN OFF AND WAS FLOATING IN THE PATIENTS KNEE. THIS MEANT THE FEMORAL COMPONENT HAD COME DISENGAGED FROM THE CEMENTED SLEEVE AND STEM CONSTRUCT. UPON OPENING THE KNEE, THE BROKEN BOLT AND FEMUR WERE TAKEN OUT EASILY. THE 5 DEGREE FEMORAL ADAPTER WAS STILL TAPER ENGAGED IN THE 20MM CEMENTED SLEEVE. THERE WAS LOOSENING REPORTED AT THE BONE/CEMENT INTERFACE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16685739 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND STERLING AND WAS TESTED FOR NICKEL ALLERGY. THE TEST CAME BACK POSITIVE SO THE SURGEON TOOK IT ALL OUT AND PUT IN AN AESCULAP REVISION CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16584963 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16214063 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TC3 REVISION KNEE? INFECTED - UNSTABLE SIGNASURE CAME BACK NEGATIVE FOR INFECTION PREVIOUS IV DRUG ABUSER, HIGH FUNCTIONING KNEE PLAN A- ATTUNE REVISION, PLAN B - ATTUNE HINGE PLAN C - TC3 FEMUR REVISION IF TIBIA WELL FIXED IN SITU - TC3FEMUR SIZE 4 PLUS DISTAL AND POSTERIOR AUGMENTS, STEM AND ADAPTOR MBT TIBIA REVISION SIZE 3, WEDGE, STEM SIZE 4 20MM INSERT TC3 RP PATELLA 41MM 3 PEG.

  Patient problems: Joint Laxity

  MAUDE report 16017397 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT KNEE. DOI: (B)(6) 2016; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15586904 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. DIRECT EXCHANGE WAS DONE. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15365195 ↗
• InjuryFeb 17, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT RECEIVED AN ABOVE THE KNEE (B)(6) DUE TO SIGNIFICANT PAIN, INFECTION, SWELLING, DRAINING, LYMPHEDEMA AND INABILITY TO AMBULATE. UPON ENTERING THE JOINT, THE CONSTRUCT WAS NOTED TO BE GROSSLY LOOSE AND INFECTED. THE (B)(6) WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2017, DOR: (B)(6) 2021, UNKNOWN KNEE. THIS COMPLAINT IS ALSO LINKED TO (B)(4) WHERE THE TIBIAL TRIAL WAS REPORTED. ANOTHER PC IS LINKED TO THIS COMPLAINT UNDER (B)(4) WHERE THE EVENT HAPPENED IN BETWEEN (B)(6) 2017- (B)(6) 2019.

  Patient problems: Ambulation or Postural Difficulties; Fluid Discharge; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13549609 ↗
• InjuryJan 24, 2022Migration; Migration

  THE PATIENT WAS REVISED DUE TO TIBIA COLLAPSED ON THE MEDIAL SIDE AND CAUSED PATIENT DISCOMFORT AND INSTABILITY. THE DOCTOR REMOVED ALL COMPONENTS AND REPLACED WITH A NEW REVISION KNEE TO CORRECT PATIENTS INSTABILITY. DOI : (B)(6) 2008. DOR : (B)(6) 2022. LEFT SIDE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 13335038 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTRAOPERATIVELY DURING A PLANNED KNEE SURGERY BECAUSE OF PATELLA-UPGRADE THE FEMORAL COMPONENT WAS FOUND TO BE FRACTURED. DOI: UNKNOWN, DOR: (B)(6) 2021. ADDITIONALLY A STEM AND SLEEVE COMPONENT WERE REPORTED AS ASSOCIATED WITH THE ADVERSE EVENT.

  Patient problems: Pain

  MAUDE report 11750470 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD A KNEE REVISION WITH RETENTION OF FEMORAL SLEEVE AND STEM WITH SROM HINGE PLACEMENT. AT THAT TIME, AN MBT REVISION TRAY WAS PLACED INTO A 29 SLEEVE WITH CEMENTED STEM. ON (B)(6) 2020, THE PATIENT HAD COMPLETE EXPLANT OF FEMUR AND TIBIAL COMPONENTS. PHYSICIAN STATES, THE PATIENT HAS "NEVER DONE WELL." INFORMATION REGARDING THE OTHER IMPLANTS NOT LISTED ARE NOT KNOWN TO THE REP. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10713305 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE SWELLING/HEMARTHROSIS EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS POSSIBLY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF REVISION (INSERT): (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE). TREATMENT: SURGICAL IRRIGATION & DEBRIDEMENT, WITH NO REVISION OF PRODUCTS.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 10691139 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. SURGEON REMOVED EVERYTHING. DOI: (B)(6) 2019; (B)(6) 2019 (INSERT); DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9891469 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD REPORTS PATIENT'S FOLLOW UP NOTES FOR HER ENCOUNTER WITH PHYSICIAN ON (B)(6) 2018 AS REPORTS OF ONGOING PAIN (WHEN ATTEMPTING TO STAND) POST REVISION OF RIGHT TOTAL KNEE ARTHROPLASTY (DOR: (B)(6) 2017). RADIOGRAPHIC IMAGES GIVE NO INDICATION OF IMPLANT DEFECTS. PATIENT HAD SEEN A PAIN SPECIALIST AND RECEIVED A RADIOFREQUENCY ABLATION WITHOUT BENEFITS. PHYSICIAN'S DECISION WAS FOR PATIENT TO CONTINUE THERAPY AND FURTHER FOLLOW UPS WITH X-RAYS.

  Patient problems: No Code Available; Pain

  MAUDE report 9511501 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE BONE TO CEMENT INTERFACE. DEPUY CEMENT MANUFACTURER WAS USED. DOI: (B)(6) 2018 (FEMUR ONLY); DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9218694 ↗
• InjuryOct 22, 2019Fracture; Fracture

  WE RECEIVED A USER REPORT FROM (B)(6) FOR A PATIENT BORN (B)(6). FRACTURE OF THE FEMORAL ANCHORAGE STEM IN REVISION ENDOPROSTHESIS. FRACTURE AT THE SCREW ANCHORAGE AT THE TRANSITION INTRAMEDULLARY STALK/; FEMORAL COMPONENT 3 YEARS AFTER IMPLANTATION.

  Patient problems: No Code Available

  MAUDE report 9218533 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2015. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9194378 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. IMPLANTS WERE TAKEN OUT. PRESS FIT COMPONENTS IMPLANTED. NO INSTRUMENTS BROKEN. NO POST OP AND XRAYS AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9180311 ↗