P.F.C. SIGMA 96-0908Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295234517), received between Jun 26, 2017 and Jul 6, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 31 reports, in the reporter's own words as published by the FDA.

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

  ON (B)(6) 2016: MALE PATIENT RECEIVED A RIGHT KNEE REVISION OF AN UNK TKA TO TREAT STIFFNESS, ARTHROFIBROSIS, AND PAIN. THE PATIENT RECEIVED A DEPUY TC3 INCLUDING A FEMORAL SLEEVE, FEMORAL ADAPTOR AND BOLT, HINGED FEMORAL COMPONENT, HINGED TIBIAL INSERT, MBT TIBIAL TRAY, TIBIAL SLEEVE, AND TIBIAL STEM. THE UNKNOWN PATELLA WAS RETAINED. UNK CEMENT WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2016: THE MALE PATIENT RECEIVED AN MUA, NON-DEPUY ASPIRATION, AND INTRAARTICULAR INJECTION TO TREAT PAIN, SWELLING, STIFFNESS, AND ARTHROFIBROSIS S/P TC3 IMPLANTATION. NO INFECTION WAS DETECTED AND ROM RESTORED TO NORMAL LIMITS. ON (B)(6) 2025: PATIENT PRESENTS TO URGENT CARE WITH SUDDEN ONSET RIGHT KNEE PAIN AND INSTABILITY. X-RAY IDENTIFIED HETEROTOPIC OSSIFICATION ALONG THE QUADRICEPS TENDON. ASPIRATION ATTEMPTED TO TEST FOR INFECTION BUT WAS UNSUCCESSFUL. BLOOD TESTS DETERMINED NO BACTERIAL OR FUNGAL INFECTION PRESENT. ON (B)(6) 2026: 56-YEAR-OLD MALE PATIENT RECEIVES A RIGHT KNEE REVISION TO TREAT WORSENING PAIN, ARTHROFIBROSIS, INSTABILITY, AND STIFFNESS. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED THE ARTHROFIBROSIS AND HETEROTOPIC OSSIFICATI

  Patient problems: Adhesion(s); Calcium Deposits/Calcification; Joint Laxity; Muscular Rigidity; Pain

  MAUDE report 25716338 ↗
• 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 24637586 ↗
• 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 24547013 ↗
• 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 20223155 ↗
• 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 20223154 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SALES REP IS REPORTING A FRACTURE OF THE FEMORAL TAPER COMPONENT.

  Patient problems: Joint Laxity

  MAUDE report 18484782 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR CHRONIC EFFUSION, DECREASED ROM, AND INCREASED PAIN. FEMORAL REVISION AND POLY EXCHANGE PERFORMED. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

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

  MAUDE report 17928208 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR CHRONIC EFFUSION, DECREASED ROM, AND INCREASED PAIN. FEMORAL REVISION AND POLY EXCHANGE PERFORMED. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

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

  MAUDE report 17928204 ↗
• 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 17718586 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE SWELLING/HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2016. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: ASPIRATED FOR BLOOD AND MILD CLOUDINESS; SENT FOR SYNOVASURE AND CAME BACK NEGATIVE FOR BOTH AEROBIC AND ANAEROBIC ORGANISM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 16149562 ↗
• InjuryDec 8, 2021Noise, Audible; Noise, Audible

  THIS PC WAS CREATED TO CAPTURE THE EVENT HAPPENED ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD A LEFT KNEE ARTHROSCOPIC SYNOVECTOMY TO ADDRESS LEFT KNEE ARTHROFIBROSIS AFTER TOTAL KNEE. THE INDICATIONS FOR SURGERY NOTED THAT THE PATIENT HAD A PREVIOUS TOTAL KNEE, AND THEN LATER ON REQUIRED A REVISION TO A TC-III STYLE IMPLANT BY DEPUY. THE PATIENT DEVELOPED CATCHING OF HIS KNEE, SWELLING, AND RECURRENT HEMARTHROSIS. DURING THIS CURRENT PROCEDURE THE SURGEON OBSERVED PERIPATELLAR ARTHROFIBROSIS. (PAGE 106 OF 274) NO COMPONENTS WERE REVISED. NO OTHER INFO WAS PROVIDED. DOI: (B)(6) 2011. DOE: (B)(6) 2013; LEFT KNEE.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12961654 ↗
• InjuryDec 8, 2021Noise, Audible; Noise, Audible

  THIS PC WAS CREATED TO CAPTURE THE EVENT HAPPENED ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD A LEFT KNEE ARTHROSCOPIC SYNOVECTOMY TO ADDRESS LEFT KNEE ARTHROFIBROSIS AFTER TOTAL KNEE. THE INDICATIONS FOR SURGERY NOTED THAT THE PATIENT HAD A PREVIOUS TOTAL KNEE, AND THEN LATER ON REQUIRED A REVISION TO A TC-III STYLE IMPLANT BY DEPUY. THE PATIENT DEVELOPED CATCHING OF HIS KNEE, SWELLING, AND RECURRENT HEMARTHROSIS. DURING THIS CURRENT PROCEDURE THE SURGEON OBSERVED PERIPATELLAR ARTHROFIBROSIS. (PAGE 106 OF 274) NO COMPONENTS WERE REVISED. NO OTHER INFO WAS PROVIDED. DOI:(B)(6), 2011, DOE: (B)(6), 2013, LEFT KNEE.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12961641 ↗
• 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 12863106 ↗
• 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 12863084 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED LAST (B)(6) 2021 DUE TO STAGE 1 INFECTION. SURGERY WAS DONE AT (B)(6) HOSPITAL. THE 1ST REVISION WAS DONE ON (B)(6) 2016. DOI: (B)(6) 2016. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 12542234 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED LAST (B)(6) 2021 DUE TO STAGE 1 INFECTION. SURGERY WAS DONE AT (B)(6) HOSPITAL. THE 1ST REVISION WAS DONE ON (B)(6) 2016. DOI: (B)(6) 2016. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 12542223 ↗
• 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 11398464 ↗
• 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 11398459 ↗
• InjuryOct 29, 2020Loss of Osseointegration; Loss of Osseointegration

  REVISION ON (B)(6) 2020 OF PREVIOUSLY REVISED KNEE TO TREAT BONE LOSS SECONDARY TO ASEPTIC FEMORAL IMPLANT LOOSENING. AN ATTUNE REVISION WAS USED TO REVISE A TC3. ORIGINAL REVISION SURGERY (TC3) WAS CONDUCTED ON 13 NOVEMBER 2009. REASON FOR RE-REVISION WAS FEMORAL LOOSENING (FEMUR + STEM CONSTRUCT). THE ORIGINAL MBT REVISION WAS STILL WELL FIXED SO DIDN'T REQUIRE REMOVAL/REPLACEMENT. TC3 FEMUR + STEM WAS REMOVED. INSERT WAS REMOVED. ATTUNE REVISION FEMUR, SLEEVE AND STEM IMPLANTED. ATTUNE REVISION CRS INSERT IMPLANTED INTO ORIGINAL MBT TRAY (NOT INDICATED).

  Patient problems: Inadequate Osseointegration; Injury; No Code Available

  MAUDE report 10758054 ↗
• InjuryOct 9, 2020Off-Label Use; Off-Label Use

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR BOLT AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A 2 STAGE BILATERAL KNEE REPLACEMENT REVISION SURGERY APPROXIMATELY 5 YEARS AGO AT THE HSS IN NEW YORK. PATIENT WAS ALLERGIC TO BONE CEMENT SO THE REVISION WAS DONE WITH SIGMA FEMORAL SLEEVES AND TC3 FEMURS WITH A MBT REVISION TIBIA WITH SLEEVES ON BOTH THE RIGHT AND LEFT WITHOUT USING CEMENT. FEMUR ON RIGHT SIDE WAS UNSUPPORTED BY BONE AND HAD DEVELOPED METAL DEBRIS FROM THE ZERO BOLT AND SLEEVE ADAPTER. SURGEON REMOVED FEMUR AND REPLACED WITH A DISTAL FEMUR ON THE RIGHT SIDE. SLEEVES ON BOTH SIDES WERE WELL FIXED ON THE RIGHT SIDE. DOI: (B)(6) 2015. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10656289 ↗
• InjuryOct 9, 2020Off-Label Use; Off-Label Use

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR BOLT AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A 2 STAGE BILATERAL KNEE REPLACEMENT REVISION SURGERY APPROXIMATELY 5 YEARS AGO AT THE HSS IN NEW YORK. PATIENT WAS ALLERGIC TO BONE CEMENT SO THE REVISION WAS DONE WITH SIGMA FEMORAL SLEEVES AND TC3 FEMURS WITH A MBT REVISION TIBIA WITH SLEEVES ON BOTH THE RIGHT AND LEFT WITHOUT USING CEMENT. FEMUR ON RIGHT SIDE WAS UNSUPPORTED BY BONE AND HAD DEVELOPED METAL DEBRIS FROM THE ZERO BOLT AND SLEEVE ADAPTER. SURGEON REMOVED FEMUR AND REPLACED WITH A DISTAL FEMUR ON THE RIGHT SIDE. SLEEVES ON BOTH SIDES WERE WELL FIXED ON THE RIGHT SIDE. DOI: (B)(6) 2015, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10656264 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TKR WHERE A STRYKER KNEE WAS UTILIZED. THIS KNEE WAS LATER REVISED TO A STRYKER REVISION. ON THE (B)(6) 2015 THE STRYKER REVISION KNEE WAS REVISED TO A PFC TC3. PATIENT HAS PRESENTED WITH A PAINFUL AND STIFF KNEE, WITH A LIMITED RANGE OF MOTION. BONE SCANS SHOW AN UPTAKE AROUND THE FEMORAL COMPONENT INDICATING A POSSIBLE LOOSE FEMORAL COMPONENT. A DECISION WAS MADE TO REVISE THE FEMORAL COMPONENT AND BEARING ON (B)(6) 2020. ON OPENING THE KNEE, THE FEMORAL COMPONENT WAS NOT OVERTLY LOOSE AND DID REQUIRE A LITTLE WORK TO REMOVE. IT WAS, HOWEVER CONSIDERED TO BE LOOSE. A DECISION WAS MADE TO CONVERT THE TC3 FEMUR TO AN S ROM HINGED KNEE (ALLOWING MORE MOBILITY) WHILE LEAVING THE REVISION TIBIAL TRAY IN SITU.

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

  MAUDE report 10581865 ↗
• 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 9637341 ↗
• 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 9637321 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUN 2019 WERE REVIEWED ON 11 JUL 2019 FOR MDR REPORTABILITY. REVISION NOTES (B)(6) 2017 INDICATE THE PATIENT WAS REVISED DUE TO INCREASED PAIN, SWELLING AND INFECTION. THIS WAS A STAGE 1 REMOVAL. STAGE 2 RE-IMPLANTATION OCCURRED ON (B)(6) 2017. BOTH SURGERIES WERE COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. = STICKER SHEETS ARE LOCATED ON PAGES 8, 9, 12, 15, 18 AND 21 OF THE ATTACHED DOCUMENT. PAGE 21 BEING THE FINAL RE-IMPLANTATION IMPLANTS.

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

  MAUDE report 8289361 ↗