P.F.C. SIGMA 96-0866Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295234302), received between Jun 23, 2017 and Mar 13, 2025 — classified as 36 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL RIGHT KNEE. SURGEON CONVERTED FROM A TC3 TO DISTAL FEMORAL REPLACEMENT. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21596954 ↗
• 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 21536912 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LEFT KNEE REVISION OCCURRED ON (B)(6) 2024 DUE TO CHRONIC PAIN. PATIENT SEEN IN EMERGENCY WITH DISLOCATED KNEE. CORRECTIVE SURGERY HAD MASSIVE METALOSIS, OSTEOLYSIS, AND POLYETHYLENE WEAR. SURGICAL DELAY UNKNOWN. ORIGINAL IMPLANT DATE UNKNOWN.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 20358862 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC PAIN. PATIENT SEEN IN ED WITH DISLOCATED KNEE. CORRECTIVE SURGERY HAD MASSIVE METALLOSIS, OSTEOLYSIS, AND POLYETHYLENE WEAR. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 20279452 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: PLEASE CONFIRM WHAT IMPLANTS WERE MISPOSITIONED. FEMORAL COMPONENT AND TIBIAL TRAY. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO, DUE TO THE MISPOSITIONING OF THE IMPLANTS. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, ALL CORRECT SIZING. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, REPORTED AS OKAY. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Joint Laxity

  MAUDE report 19261605 ↗
• InjuryMar 15, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE BOLT INTERFACE. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE

  Patient problems: Insufficient Information

  MAUDE report 18912133 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PER THE SURGEON, THE PATIENT WAS INFECTED. THE SURGEON REMOVED ALL COMPONENTS AND PUT IN SPACER. SURGICAL DELAY WAS UNKNOWN. DOI: ON (B)(6) 2020, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18655138 ↗
• InjuryAug 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD PRIMARY TKR (LCS WITH DUOFIX FEMUR) (B)(6) 2008. HAS HAD ONGOING ISSUES SINCE WITH PAIN, SWELLING & LOOSENING. HAD PARTIAL REVISIONS IN (B)(6) 2011 & (B)(6) 2012 FOR PAIN & LOOSENING. PATIENT PRESENTED AGAIN IN 2017 WITH PAIN & BONE SCANS SUGGESTING LOOSENING - REVISED ENTIRE CONSTRUCT TO TC3 WITH MBT SLEEVES & STEMS. PRESENTED AGAIN IN 2023 WITH PAIN. BONE SCAN SUGGESTED LOOSENING SO REVISED TO ATTUNE REVISION WITH STEMS & SLEEVES. IMPLANTS WEREN'T GROSSLY LOOSE AND REQUIRED SOME WORK (FLEXIBLE OSTEOTOMES AROUND METAPHYSEAL SLEEVES & SLAP HAMMER ATTACHMENTS) TO REMOVE. DOI: (B)(6) 2008. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17459974 ↗
• InjuryAug 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD PRIMARY TKR (LCS WITH DUOFIX FEMUR) (B)(6) 2008. HAS HAD ONGOING ISSUES SINCE WITH PAIN, SWELLING & LOOSENING. HAD PARTIAL REVISIONS IN (B)(6) 2011 & (B)(6) 2012 FOR PAIN & LOOSENING. PATIENT PRESENTED AGAIN IN 2017 WITH PAIN & BONE SCANS SUGGESTING LOOSENING - REVISED ENTIRE CONSTRUCT TO TC3 WITH MBT SLEEVES & STEMS. PRESENTED AGAIN IN 2023 WITH PAIN. BONE SCAN SUGGESTED LOOSENING SO REVISED TO ATTUNE REVISION WITH STEMS & SLEEVES. IMPLANTS WEREN'T GROSSLY LOOSE AND REQUIRED SOME WORK (FLEXIBLE OSTEOTOMES AROUND METAPHYSEAL SLEEVES & SLAP HAMMER ATTACHMENTS) TO REMOVE. DOI: (B)(6) 2008. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17459972 ↗
• 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)(6) 2023, THE PATIENT CAME TO THE HOSPITAL COMPLAINING OF THE SUDDEN KNEE PAIN, AND THE INFECTION WAS CONFIRMED. NO FURTHER INFORMATION IS AVAILABLE. DOI; (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17116846 ↗
• InjuryMay 12, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT COMES FOR FURTHER DISCUSSION REGARDING PAINFUL BILATERAL TOTAL KNEE ARTHROPLASTIES. THE PATIENT HAD A RIGHT TOTAL KNEE IN 2006 AND REVISION IN 2019. SHE HAD A LEFT TOTAL KNEE IN 2006, A REVISION IN 2019 AND A SCOPE DEBRIDEMENT IN 2020. THE PATIENT CONTINUES TO HAVE ONGOING PAIN AND DISCOMFORT IN BOTH OF THE KNEES. THE PAIN IS DAILY. IT IS STARTING TO LIMIT HER ACTIVITIES. SHE HAS GOOD RANGE OF MOTION. SHE HAS SOME SWELLING AT TIMES. SHE HAS SOME GRINDING AND POPPING IN BOTH KNEES. THE LEFT KNEE HURTS MORE OFTEN THAN THE RIGHT KNEE. SHE DID PREVIOUSLY DISCUSS REVISION SURGERY WITH SURGEON. SHE WOULD LIKE TO PROCEED WITH STAGED TKA REVISIONS, LEFT ONE FIRST. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16918631 ↗
• InjuryMay 12, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT COMES FOR FURTHER DISCUSSION REGARDING PAINFUL BILATERAL TOTAL KNEE ARTHROPLASTIES. THE PATIENT HAD A RIGHT TOTAL KNEE IN 2006 AND REVISION IN 2019. SHE HAD A LEFT TOTAL KNEE IN 2006, A REVISION IN 2019 AND A SCOPE DEBRIDEMENT IN 2020. THE PATIENT CONTINUES TO HAVE ONGOING PAIN AND DISCOMFORT IN BOTH OF THE KNEES. THE PAIN IS DAILY. IT IS STARTING TO LIMIT HER ACTIVITIES. SHE HAS GOOD RANGE OF MOTION. SHE HAS SOME SWELLING AT TIMES. SHE HAS SOME GRINDING AND POPPING IN BOTH KNEES. THE LEFT KNEE HURTS MORE OFTEN THAN THE RIGHT KNEE. SHE DID PREVIOUSLY DISCUSS REVISION SURGERY WITH SURGEON. SHE WOULD LIKE TO PROCEED WITH STAGED TKA REVISIONS, LEFT ONE FIRST. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16918608 ↗
• InjuryMay 3, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT. ADAPTER BOLT WAS BROKEN AT THREADS. ALL PARTS WERE REMOVED. SLEEVE AND STEM WERE WELL FIXED AND WERE NOT REMOVED. S ROM HINGE FEMUR WAS IMPLANTED. TIBIAL COMPONENT WAS NOT REVISED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16860382 ↗
• InjuryMay 3, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT. ADAPTER BOLT WAS BROKEN AT THREADS. ALL PARTS WERE REMOVED. SLEEVE AND STEM WERE WELL FIXED AND WERE NOT REMOVED. S ROM HINGE FEMUR WAS IMPLANTED. TIBIAL COMPONENT WAS NOT REVISED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16860380 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT RESECTION WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14141847 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED THE KNEE BECAUSE THE PATIENT COMPLAINED OF SHIN PAIN. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12414090 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED THE KNEE BECAUSE THE PATIENT COMPLAINED OF SHIN PAIN. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12414073 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAINFUL RIGHT TOTAL KNEE WITH CREPITANS, ADHESIONS EVENT IS SERIOUS AND IS CONSIDERED. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2010 (COMPETITOR KNEE SYSTEM). DATE OF REVISION #1: (B)(6) 2010 (REVISION OF COMPETITOR FEMUR, TIBIAL TRAY, INSERT - COMPETITOR PATELLA RETAINED). DATE OF EVENT (ONSET): (B)(6) 2013. (RIGHT KNEE). TREATMENT: SURGICAL ARTHROTOMY WITH EXCISION OF SCAR TISSUE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12363735 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SIGNIFICANT FLEXION CONTRACTURE BUT INSTABILITY IN FLEXION. TIBIAL COMPONENTS REMOVED ALONG WITH FEMORAL COMPONENTS AND CONVERTED TO DISTAL FEMORAL REPLACEMENT ON EXISTING FEMORAL SLEEVE AND STEM. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11555002 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR A DISLOCATED TC3 RP REVISION KNEE. PATIENT'S SOFT-TISSUE WAS DISCOVERED TO BE COMPROMISED UPON EXPOSURE OF THE JOINT. THE PATIENT WAS REVISED TO AN SROM HINGE WITHOUT ISSUE. THE INSERT WAS STILL IN THE TRAY AND DID NOT SPIN 90 DEGREES. THE FEMUR DISLOCATED DUE TO SOFT TISSUE INJURY.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 11505022 ↗
• InjuryFeb 26, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO BONE AND CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2018 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11388325 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS FROM (B)(6) 2020 NOTE THAT THE PATIENT WENT THE ER DUE TO WORSENING LEFT KNEE PAIN AND GOT AN INJECTION OF TORADOL. DOI: (B)(6) 2016, DOR: (B)(6) 2017 (CAPTURED IN (B)(4), DOE: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10582941 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO MCL RUPTURE. REVISED FEMORAL COMPONENT AND TIBIAL POLY TO A SROM HINGE. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10291841 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS HAVING PAIN END OF STEM. REMOVED ALL COMPONENTS AND REVISED TO OTHER REVISION KNEE SYSTEM. DOI: (B)(6) 2019; DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10269201 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  .

  Patient problems: No Code Available; Pain

  MAUDE report 10269200 ↗