P.F.C. SIGMA 96-0901Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295234470), received between Jun 26, 2017 and Dec 15, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED WITH TC3 FEMUR WITH POROUS COATED SLEEVE DUE TO INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23803026 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO INFECTION. ALL PARTS WERE EXPLANTED AND A CEMENT SPACER FROM A DIFFERENT VENDOR WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23016539 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO LOOSENING. THE CEMENT MANUFACTURER WAS COMPETITOR. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20223161 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED, DUE TO INSTABILITY. THERE WAS NO LOOSENING. THE CEMENT MANUFACTURER WAS COMPETITOR. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20223152 ↗
• 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 17049695 ↗
• 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 17049686 ↗
• 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 15974024 ↗
• 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 15973965 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS INFECTION, PAIN, SWELLING, SYNOVITIS, REMOVAL OF FIBROUS TISSUE, AND TIBIAL COMPONENT LOOSENING. THE SURGEON HAD TO PERFORM A CORONAL PLANE OSTEOTOMY OF THE DISTAL FEMUR TO REMOVE THE WELL-FIXED FEMORAL COMPONENTS. THERE WAS NOTED TO BE REMOVAL OF CERCLAGE WIRES ON THE FEMUR THAT WERE PLACED PRIOR FOR AN UNKNOWN REASON ON AN UNKNOWN DATE. IT IS UNKNOWN IF THE WIRES WERE PREVIOUSLY PLACED DUE TO A COMPLICATION OR TO PREVENT ANY ISSUES.

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

  MAUDE report 12863045 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS INFECTION, PAIN, SWELLING, SYNOVITIS, REMOVAL OF FIBROUS TISSUE, AND TIBIAL COMPONENT LOOSENING. THE SURGEON HAD TO PERFORM A CORONAL PLANE OSTEOTOMY OF THE DISTAL FEMUR TO REMOVE THE WELL-FIXED FEMORAL COMPONENTS. THERE WAS NOTED TO BE REMOVAL OF CERCLAGE WIRES ON THE FEMUR THAT WERE PLACED PRIOR FOR AN UNKNOWN REASON ON AN UNKNOWN DATE. IT IS UNKNOWN IF THE WIRES WERE PREVIOUSLY PLACED DUE TO A COMPLICATION OR TO PREVENT ANY ISSUES.

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

  MAUDE report 12862970 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PERIPROSTHETIC KNEE INFECTION. NO DELAY IN SURGERY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11398496 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PERIPROSTHETIC KNEE INFECTION. NO DELAY IN SURGERY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11398491 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS EXPLANTED AND A KASM ANTIBIOTIC SPACER WAS IMPLANTED. THERE IS NO FURTHER PATIENT INFORMATION AVAILABLE. HERE ARE THE FINAL 4 EXPLANTED IMPLANTS: 96-0901, LOT #D39FB4, 96-0901, LOT #H19755, 96-0908, LOT #HH7455, 96-0908, LOT # H08683. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9637344 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS EXPLANTED AND A KASM ANTIBIOTIC SPACER WAS IMPLANTED. THERE IS NO FURTHER PATIENT INFORMATION AVAILABLE. HERE ARE THE FINAL 4 EXPLANTED IMPLANTS: 96-0901, LOT #D39FB4, 96-0901, LOT #H19755, 96-0908, LOT #HH7455, 96-0908, LOT # H08683. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9637337 ↗
• 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 9202779 ↗
• InjuryJan 30, 2019Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INCREASED PAIN AND SWELLING.

  Patient problems: No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 8289384 ↗
• InjuryOct 11, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 7955824 ↗
• InjuryJun 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATED THAT THE PATIENT HAD PRIMARY TKA ON BOTH SIDES 2 YEARS AGO BUT HAS EXPERIENCED CHRONIC EFFUSIONS ON BOTH KNEES SINCE PRIMARY SURGERY. PATIENT RTKA WAS REVISED ON (B)(6) 2017. HE DID PERFECTLY WELL FOR 8 DAYS ON THE 9TH DAY HE EXPERIENCED ACUTE SWELLING AND APPARENT INFECTION. SURGEON ELECTED TO I&D WITH POLY EXCHANGE ON (B)(6) 2017. HE ELECTED TO REMOVE ALL IMPLANTS ON (B)(6) 2017 AND IMPLANT ANTIBIOTIC BEADS, SPACER AND LOOSELY CEMENTED PRIMARY CR ATTUNE FEMUR, LOOSELY CEMENTED PSRP INSERT WITH TOP POST REMOVED. SURGEON IS AWARE THIS IS OFF LABEL BUT FELT IT WAS THE BEST INTEREST OF THE PATIENT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 6666537 ↗