SIGMA 96-0086Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295232537), received between Oct 15, 2018 and Jun 20, 2025 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (2 reports).

24 other recalls cover devices cleared under the same FDA submission (K241000, K950010, K952830); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISTAL FEMUR FRACTURE FROM A FALL. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 22301468 ↗
• InjuryJun 4, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE FEMUR COMPONENT WERE LOOSE DUE TO PRE-PATELLAR BURSA. THE FEMUR AND POLY WERE REPLACED.

  Patient problems: Inflammation

  MAUDE report 19461008 ↗
• 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 16683978 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT THE TKA SURGERY WITH PFC S IMPLANTS. AFTER THE SURGERY, ON (B)(6) 2021, THE INFECTION OCCURRED. REMOVAL OF THE IMPLANTS WAS PERFORMED ON (B)(6) 2021. THE SURGERY WAS COMPLETED SUCCESSFULLY NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12909707 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE PRIMARY SURGERY. THIS PC REPORTS ABOUT THE REMOVAL SURGERY DUE TO INFECTION. AFTER THE REVISION TKA SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL SURGERY ON (B)(6) 2021 BECAUSE INFECTION OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12882765 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INFECTION WAS CONFIRMED. AS THIS WAS A REVISION PROCEDURE, THERE WAS NO SURGICAL DELAY. THE PRODUCT SPECIALIST THINKS IT WAS A COMPETITORS CEMENT THAT WAS USED. ALL KNEE COMPONENTS WERE REMOVED, AND A TEMPORARY CEMENT SPACER WAS INSERTED.

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

  MAUDE report 12089651 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION OF THE LEFT KNEE. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11399998 ↗
• InjuryJan 13, 2021Use of Device Problem; Use of Device Problem

  REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO PAIN, LIMITED RANGE OF MOTION AND LOOSENING AND MISPOSITION OF THE FEMORAL COMPONENT. UPON ENTERING THE JOINT, THICKENED SYNOVIUM WAS ENCOUNTERED AND A SYNOVECTOMY WAS PERFORMED. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AT THE BONE TO CEMENT INTERFACE. IT WAS ALSO INDICATED THAT THE FEMORAL COMPONENT HAD BEEN PREVIOUSLY PLACED IN A STATE OF FLEXION MISPOSITION, THIS WAS ALSO CORRECT WITH IMPLANTATION OF A NEW FEMORAL COMPONENT IN PROPER POSITION. FEMORAL COMPONENT AND INSERT WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED ALONG WITH COMPETITOR CEMENT. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016 (PATELLA). DOI: (B)(6) 2018 (INSERT, TIBIAL AND FEMORAL COMPONENTS). DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain; Synovitis

  MAUDE report 11166036 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RADIOLOGY REPORT (B)(6) 2017 (POST REVISION SURGERY) REVEALS THE HARDWARE APPEARS TO BE INTACT. THERE IS A REMOTE AVULSION FRACTURE OF THE MEDIAL ASPECT OF THE MEDIAL FEMORAL CONDYLE. THERE IS NO INDICATION OF TREATMENT RELATED TO THIS AVULSION FRACTURE. IT IS UNKNOWN WHEN THIS FRACTURE OCCURRED, DURING THE REMOVAL OF PREVIOUS IMPLANTS OR IMPLANTATION OF REVISION IMPLANTS. THEREFORE, THIS WILL NOT BE CAPTURED AS A SEPARATE EVENT. OFFICE NOTES (B)(6) 2017 ¿ (B)(6) 2020 INDICATE THE PATIENT CONTINUES TO EXPERIENCE PAIN, STIFFNESS, WEAKNESS, INSTABILITY, SWELLING AND LEG LENGTH DISCREPANCY. THE PATIENT ALSO STATES SHE HAS SKIN DISCOLORATION ON THE MEDIAL ASPECT OF HER LOWER LEG. IT IS INDICATED THE SURGEON HAS DISCUSSED THE POTENTIAL NEED FOR FUTURE REVISION, HOWEVER, THERE IS NO INDICATION AN ADDITIONAL REVISION SURGERY HAS TAKEN PLACE. IT IS INDICATED, HOWEVER, THAT THE PATIENT HAS RECEIVED PAIN BLOCK INJECTIONS DUE TO HER KNEE PAIN. A SHOE HEEL LIFT WAS PROVIDED TO HELP ADDRESS THE LEG LENGTH DISCREPANCY. WHOLE BODY BONE SCAN WAS PERFORMED ON (B)(6) 2019 REVEALS LOW-LEVEL ACTIVITY DIFFUSELY AROUND THE LEFT KNEE PROSTHETIC. NO SIGN OF OSTEOMYELITIS OR FRACTURE. DOI: (B)(6) 2016 (PAT

  Patient problems: Fatigue; Joint Laxity; Muscular Rigidity; Pain; Physical Asymmetry; Skin Discoloration; Swelling/ Edema

  MAUDE report 10927385 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING IMPLANTS WERE REMOVED TODAY AT (B)(6) BY MR (B)(6) DURING KNEE REVISION SURGERY. FIXED FLEXION DEFORMITY OF 30DEG WAS THE REASON FOR REVISION. THIS WAS THE SECOND REVISION. THE FEMUR AND TIBIAL INSERT WERE IMPLANTED APPROX 2 YEARS AGO, THE TIBIA APPROX 4 YEARS AGO.

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

  MAUDE report 10484575 ↗
• InjuryMar 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9832618 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BROKE HER DISTAL FEMUR DUE TO FALL. A DISTAL FEMUR WITH SLEEVE AND STEM WAS USED TO GAIN STABILITY. ORIGINAL IMPLANT DATE WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9701638 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FALL AND TORE HER EXTENSOR MECHANISM. AFTER FALLING, THE SURGEON REPAIRED THE EXTENSOR AND WENT DOWN A POLY SIZE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9370843 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SOME ISOLATED FEMORAL PAIN. DOI: 1-2 YEARS AGO; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8605445 ↗
• MalfunctionApr 26, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  SURGEON WAS PERFORMING A COMPLEX PRIMARY TOTAL KNEE REPLACEMENT, AND WAS USING THE TC3 KNEE SYSTEM. AFTER THE CORRECT IMPLANT SIZES WERE REQUESTED, THEY WERE OPENED AND THE SURGEON PREPARED THEM FOR IMPLANTATION. ON REMOVING THE FEMORAL IMPLANT FROM THE PACKAGING IT WAS NOTED THERE WAS TWO WHITE MARKS ON THE DISTAL PART. THE SURGEON ATTEMPTED TO REMOVE THEM, AND WAS CONCERNED HE MAY SCRATCH THE SURFACE OF THE IMPLANT, THEREBY RISKING THE EFFICACY OF THE PROCEDURE. IT WAS DECIDED TO USE A NEW IMPLANT TO COMPLETE THE PROCEDURE, AND I REPORTED THE INCIDENT WHILST IN THEATRE.

  Patient problems: Not Applicable

  MAUDE report 8555632 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMMUNICATION RECEIVED. AS VERBALIZED,"I HAVE A DEPUY TC KNEE REVISION SYSTEM- PFC SIGMA KNEE REPLACEMENT. I HAVE LIMITED RANGE OF MOTION, THE PAIN GOES DOWN TO THE FEMUR PART OF THE LEG DOWN TO MY ANKLE. I'M HAVING PROBLEMS OF THIS APART FROM BEING NOT STABLE." UPDATE 23-MAY-2018: PATIENT CONFIRMED THE ABOVE SYMPTOMS OF PAIN, SWELLING, AND DECREASED ROM. MEDICAL RECORDS REPORT PAIN, AND INDICATE THAT PATIENT HAS HAD A KNEE REVISION ON AN UNKNOWN DATE. DOI: (B)(6) 2013. DOR: UNKNOWN (LEFT KNEE).

  Patient problems: Fatigue; Loss of Range of Motion; Nerve Damage; No Code Available; Pain; Physical Asymmetry; Swelling; Swelling/ Edema; Weakness

  MAUDE report 8239326 ↗
• InjuryNov 1, 2018Biocompatibility; Biocompatibility

  CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA CLUNK SYNDROME.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 8027553 ↗
• InjuryNov 1, 2018Biocompatibility; Biocompatibility

  CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA CLUNK SYNDROME.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 8027521 ↗
• InjuryOct 29, 2018Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED BECAUSE THE FEMUR WAS LOOSE AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: Failure of Implant

  MAUDE report 8016791 ↗
• InjuryOct 15, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LOOSENING OF FEMORAL COMPONENTS POST REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 7967108 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K950010, K952830. One submission often covers many models, so check the product and lot details in each record.

• Z-2949-2018 · Jul 18, 2018 · Terminated
  P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
• Z-0420-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, 4, UHMWPE, sterile; Product Code/REF 96-2652.
• Z-0387-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 12.5 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0432.
• Z-0388-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 15.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0433.
• Z-0418-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 71mm M/L, 47mm A/P, 15.0mm, 3, UHMWPE, sterile; REF Product Code/96-2643.
• Z-0401-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551.
• Z-0391-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-0442.
• Z-0396-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521.
• Z-0390-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 10.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0441.
• Z-0400-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544.
• Z-0397-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522.
• Z-0422-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 17.5 mm, 2, UHMWPE, sterile; Product Code/REF 96-2713.
• Z-0395-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 89 mm M/L, 59 mm A/P, 10.0 mm, 6, UHMWPE, sterile; Product Code/REF 96-0471.
• Z-0419-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 8.0mm, 4, UHMWPE, sterile; Product Code/REF 96-2650.
• Z-0392-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 10.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0451.

…and 9 more.