P.F.C. SIGMA 96-0906Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295234500), received between Dec 21, 2017 and Mar 19, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT INITIAL TKA WAS UNKNOWN. DR DID THE FIRST REVISION BACK ON (B)(6) 2013 AT HOSPITAL. THERE WAS A LOOSENING BUT LOOSENING INTERFACE WAS UNKNOWN AND CEMENT MANUFACTURER WAS DEPUY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24637601 ↗
• InjuryMar 9, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT HAD FIRST REVISION DONE ON (B)(6) 2013 FOR AN UNKNOWN REASON. THE PATIENT UNDERWENT THE SECOND KNEE SURGERY REVISION DUE TO LOOSENING OF THE FEMORAL IMPLANT AND A THIGH PAIN. THE FEMORAL COMPONENT AS WELL AS THE FB TC3 INSERT WERE REVISED, AND STABILITY OF THE KNEE WAS CONFIRMED AFTER THE NEW FEMORAL COMPONENTS WERE IMPLANTED. THE TIBIAL COMPONENT REMAINED WELL FIXED, AND NO DELAYS OR ADDITIONAL ADVERSE EVENTS OCCURRED ACTIVITY LEVEL: YES. DOI: (B)(6) 2013. DOR-UNKNOWN AFFECTED SIDE: LEFT KNEE. THIS REPORT CAPTURES THE SECOND REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 24547014 ↗
• InjurySep 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN. ONCE SURGEON FLEXED THE KNEE, THE FEMUR FELL OFF. THE FEMORAL ADAPTER BOLT BROKE. HAD TO REMOVE STEM & SLEEVE AND PUT IN A NEW STEM AND SLEEVE WITH A TC3 FEMUR. DOI: UNKNOWN. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17718615 ↗
• InjuryJun 2, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO PROGRESSIVE RIGHT KNEE PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI- (B)(6) 2016. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17049660 ↗
• InjuryJun 2, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO PROGRESSIVE RIGHT KNEE PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI- (B)(6) 2016. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17049639 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION TKR AS PART OF A SECOND STAGE DUE TO INFECTION. PATIENT HAS PRESENTED TO DR DAVID LIU AND UNDERGONE A POLY EXCHANGE AND WASHOUT. AT THIS STAGE, ON OPENING THE KNEE, THE KNEE WAS OBVIOUSLY PUSSY AND INFECTED. THE KNEE WAS WASHED OUT AND THE POLY BEARING EXCHANGED. SAMPLES TAKEN AT THIS STAGE ARE POSITIVE FOR BACTERIA (SENSITIVE STRAIN). A DECISION WAS MADE TO GO BACK INTO THE KNEE AND REMOVE ALL COMPONENTS AS PART OF A TWO STAGE PROCEDURE. ON OPENING THE KNEE IT APPEARED RELATIVELY ANGRY BUT NOT OVERTLY PUSSY. THE COMPONENTS WERE REMOVED, THE TISSUE DEBRIDED AND A TEMPORARY "KIWI" SPACER IMPLANTED (ATTUNE PS FEMUR AND AN ATTUNE PS RP INSERT) AS PART OF THE TEMPORARY SPACER. THESE WILL BE REMOVED IN DUE COURSE AND EXCHANGED FOR A REVISION SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 15973919 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION TKR AS PART OF A SECOND STAGE DUE TO INFECTION. PATIENT HAS PRESENTED TO DR DAVID LIU AND UNDERGONE A POLY EXCHANGE AND WASHOUT. AT THIS STAGE, ON OPENING THE KNEE, THE KNEE WAS OBVIOUSLY PUSSY AND INFECTED. THE KNEE WAS WASHED OUT AND THE POLY BEARING EXCHANGED. SAMPLES TAKEN AT THIS STAGE ARE POSITIVE FOR BACTERIA (SENSITIVE STRAIN). A DECISION WAS MADE TO GO BACK INTO THE KNEE AND REMOVE ALL COMPONENTS AS PART OF A TWO STAGE PROCEDURE. ON OPENING THE KNEE IT APPEARED RELATIVELY ANGRY BUT NOT OVERTLY PUSSY. THE COMPONENTS WERE REMOVED, THE TISSUE DEBRIDED AND A TEMPORARY "KIWI" SPACER IMPLANTED (ATTUNE PS FEMUR AND AN ATTUNE PS RP INSERT) AS PART OF THE TEMPORARY SPACER. THESE WILL BE REMOVED IN DUE COURSE AND EXCHANGED FOR A REVISION SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 15973911 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  11TH REVISION AND REMOVAL OF ALL PREVIOUS REVISION COMPONENTS TO TREAT LEFT KNEE SWELLING AND CONFIRMED INFECTION. PATIENT RECEIVED A TEMPORARY ATTUNE ANTIBIOTIC SPACER TO BE REMOVED WHEN THE INFECTION HAS CLEARED. DOI: (B)(6) 2020 (10TH REVISION AND IMPLANTATION OF REVISION PRODUCTS); DOR: (B)(6) 2021 (11TH REVISION AND REMOVAL OF ALL PRODUCTS); LEFT KNEE.

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

  MAUDE report 12149706 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION AND REMOVAL OF ALL PREVIOUS REVISION COMPONENTS. REVISION WAS REQUIRED DUE TO INFECTION BEING PRESENT WITH SWELLING AND FLUID WITHIN THE KNEE. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN KNEE.

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

  MAUDE report 11887181 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2017, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11455618 ↗
• InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE SURGICAL IRRIGATION AND DEBRIDEMENT WITH WOUND CLOSURE DUE TO WOUND DEHISCENCE AND CONTINUED INFECTION. UPON ENTERING THE WOUND, NECROTIC TISSUE WAS EXCISED, AND A THOROUGH IRRIGATION WAS DONE. NO IMPLANTS WERE REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Necrosis; Wound Dehiscence

  MAUDE report 11223417 ↗
• InjuryJun 29, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2018, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10207459 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE BECAME UNSTABLE, SO DOCTOR CONVERTED TC3 TO LPS DISTAL FEMUR. DOI: (B)(6) 2016, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9818533 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE BECAME UNSTABLE, SO DOCTOR CONVERTED TC3 TO LPS DISTAL FEMUR. DOI: (B)(6) 2016, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9818526 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2011. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9548179 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 THE PATIENT UNDERGOES A REVISION RIGHT TOTAL KNEE REPLACEMENT TO A HINGED KNEE REPLACEMENT CONSTRUCT DUE TO FAILURE OF RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO INSTABILITY AND POSTEROLATERAL CORNER DEFICIENCY. FEMORAL COMPONENT AND INSERT WERE REVISED AND DEPUY FEMORAL IMPLANT, AUGMENTS, AND TIBIAL INSERT WERE IMPLANTED. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9402097 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 THE PATIENT UNDERGOES A REVISION RIGHT TOTAL KNEE REPLACEMENT TO A HINGED KNEE REPLACEMENT CONSTRUCT DUE TO FAILURE OF RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO INSTABILITY AND POSTEROLATERAL CORNER DEFICIENCY. FEMORAL COMPONENT AND INSERT WERE REVISED AND DEPUY FEMORAL IMPLANT, AUGMENTS, AND TIBIAL INSERT WERE IMPLANTED. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9402095 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS A VERY POOR RANGE OF MOTION, 40 DEGREE FROM 30-70 OF FLEXION. THE SURGEON CHOOSES TO REMOVE THE FEMORAL COMPONENTS AND PLACE A HINGED PROSTHESIS. DOI: (B)(6) 2017; DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9202780 ↗
• InjuryOct 17, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT WAS BROUGHT TO THE SURGERY FOR KNEE PAIN AND LYTIC LESION APPARENT ON X-RAY. DISCOVERED INTRA-OPERATIVELY SIGNS OF METALLOSIS WITH LYTIC LESIONS WITH PSEUDO TUMOR BONE LOSS AT THE DISTAL FEMUR. IT WAS DISCOVERED THAT METALLOSIS WERE ORIGINATED AT THE FEMORAL ADAPTER BOLT AND UNIVERSAL FEMORAL SLEEVE INTERFACE. METAPHYSEAL AND UNIVERSAL SLEEVES CONTINUE TO BE WELL FIXED. BACK TABLE PHOTOS AND PRE-OPERATIVE X-RAYS AVAILABLE UPON REQUEST. DOI: (B)(6) 2014; DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; No Code Available; Pain

  MAUDE report 9202268 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTED LEFT TOTAL KNEE. DOI: (B)(6) 2018, DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9135749 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTED LEFT TOTAL KNEE. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9135732 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. FEMUR WAS REVISED.

  Patient problems: No Code Available; Pain

  MAUDE report 8535499 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. FEMUR WAS REVISED.

  Patient problems: No Code Available; Pain

  MAUDE report 8535496 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INCREASED PAIN AND SWELLING.

  Patient problems: No Code Available; Swelling; Unspecified Infection

  MAUDE report 8289374 ↗
• InjuryDec 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON REMOVED ALL IMPLANTS AND PERFORMED EXTENSIVE I&D AND PLACEMENT OF ANTIBIOTIC CEMENT COATED TIBIAL NAIL FOR TEMPORARY STABILIZATION OF THE KNEE.DOI: (B)(6) 2017, DOR: (B)(6) 2017, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7139504 ↗