SIGMA 96-0083Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295232506), received between Jan 10, 2018 and Apr 24, 2026 — classified as 49 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 reports).

8 other recalls cover devices cleared under the same FDA submission (K241000, 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT SEPTIC A LOOSENING. IT WAS STATED THAT FEMUR/TIBIA WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS UNKNOWN. DOI: ON (B)(6) 2017, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24981301 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS A FRACTURE IN THE LEFT KNEE. A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2025. IT WAS NOTED THE BONE BEHIND THE FEMORAL COMPONENT WAS IN A VERY BAD CONDITION, THERE WAS NO BONY SUPPORT FOR THE METAL COMPONENT.

  Patient problems: Bone Notching; Limb Fracture

  MAUDE report 23717502 ↗
• InjuryNov 14, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT TC3 BOLT CAME LOOSE FROM ADAPTER AND FEMUR WAS MOVING IN THE JOINT. SLEEVE REMAINED AND PATIENT WAS REVISED TO A NOILES FEMUR/POLY HINGE KNEE WAS IMPLANTED. THERE WAS LOOSENING OF FEMUR, BOLT, ADAPTER AT NON-CEMENTED INTERFACE. CEMENT MANUFACTURE WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23555776 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL TOTAL KNEE. DOI: (B)(6) 2015. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22027344 ↗
• InjuryApr 21, 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 TO HINGE DUE TO LAXITY IN THE TISSUES. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21873170 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNDISCOVERED NICKEL ALLERGY. THEY HAD PAIN THROUGHOUT THEIR LEG, SO THE SURGEON REPLACED EVERYTHING WITH COMPETITOR IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18184857 ↗
• InjuryOct 25, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. REVISED FEMUR AND TIBIAL COMPONENTS. DOI: (B)(6), 2018. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18002543 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS EXPLANTED TC3 CONSTRUCT DUE TO NICKEL ALLERGY. DOI: (B)(6) 2020, DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17490528 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2010. DATE OF REVISION: (B)(6) 2013. DATE OF EVENT: (B)(6) 2011. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 17412547 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OF A KNEE WAS (B)(6) 2018, AND A SUBSEQUENT POLY EXCHANGE WAS PERFORMED ON (B)(6) 2021. PATIENT PRESENTS WITH PAIN AND INSTABILITY. TAKEN TO TRAY TO ADDRESS CAUSE AS XRAYS DO NOT SHOW CLEAR ISSUES. INSERT, FEMORAL COMPONENT, FEM ADAPTER AND BOLT WERE REMOVED BUT SLEEVE AND STEM WERE LEFT AS THEY WERE WELL FIXED. AN LPS ADAPTER AND DISTAL FEMORAL COMPONENT WERE PLACED ALONG WITH HINGED INSERT UNEVENTFULLY. NO PATIENT HARM OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17208025 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2017. DATE OF REVISION: (B)(6) 2023. (LEFT KNEE). TREATMENT: FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Joint Laxity; Pain; Wound Dehiscence

  MAUDE report 17058191 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INSTABILITY. DOI: (B)(6) 2017; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17044291 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED KNEE PAIN AND DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017, DATE OF EVENT: UNK 2019, (LEFT KNEE). TREATMENT: EXPLANT OF ALL COMPONENTS, EIGHT WEEKS OF ANTIBIOTICS (RE-IMPLANTATION OF COMPONENTS PLANNED AFTER ANTIBIOTIC TREATMENT)

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16918916 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TC3 REVISION KNEE? INFECTED - UNSTABLE. SIGNASURE CAME BACK NEGATIVE FOR INFECTION. PREVIOUS IV DRUG ABUSER, HIGH FUNCTIONING KNEE. PLAN A- ATTUNE REVISION, PLAN B - ATTUNE HINGE, PLAN C - TC3 FEMUR REVISION IF TIBIA WELL FIXED. IN SITU - TC3FEMUR SIZE 4 PLUS DISTAL AND POSTERIOR AUGMENTS, STEM AND ADAPTOR. MBT TIBIA REVISION SIZE 3, WEDGE, STEM. SIZE 4 20MM INSERT TC3 RP. PATELLA 41MM 3 PEG.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 15968482 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED PATIENT WAS UNSTABLE. THE SURGEON REMOVED THE FEMORAL COMPONENTS/POLY AND REPLACED FEMORAL COMPONENTS/POLY. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: ON (B)(6) 2018. DOR: ON (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15910091 ↗
• InjuryNov 9, 2022Loss 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 IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. CEMENT MANUFACTURER WAS UNKNOWN. PATIENT TOLD SURGEON HE HAD BEEN DOING GREAT, LOVED HIS KNEE, AND GOING TO THE GYM EVERYDAY SINCE HIS LT REVISION TKA SURGERY THAT WAS PERFORMED BACK IN 2014. HE TOLD THE SURGEON THAT THE PAST COUPLE OF MONTHS HE STARTED TO HAVE PAIN IN HIS LT KNEE. THE SURGEON TOLD SALES REP THAT THE PATIENT ONLY WANTED TO DO A POLY REVISION AND THE SURGEON WAS CERTAIN THAT NO COMPONENTS WERE LOOSE. THE SURGEON ASKED THAT STAB RP AND TC3 RP INSERTS BE AVAILABLE FOR THIS SURGERY. AFTER OPENING UP THE KNEE THE SURGEON SAID THE FEMUR WAS GROSSLY LOOSE AND WAS COMPLETELY CAUGHT OFF GUARD BY THIS. AFTER REMOVING THE FEMUR THE SURGEON NOTICE THAT THE FEMORAL ADAPTER BOLT HAD BROKEN OFF THE FEMUR. 1/2 WAS IN THE FEMORAL COMPONENT AND THE OTHER 1/2 OF THE BOLT WAS STILL IN THE SLEEVE. THE SURGEON TRIED AND COULDN'T REMOVE THE BROKEN BOLT AND ADAPTER SLEEVE FROM THE FEMORAL METAPHYSEAL SLEEVE. WE HAD SROM FEMORAL COMPONENTS AVAILABLE ALONG WITH A FULL ATTUNE REVISION SET. HOWEVER, THE SURGEON TOLD ME THAT HE DIDN'T WANT TO CAUSE A LOT OF BONE DAMAGE TO

  Patient problems: Pain

  MAUDE report 15759907 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY AND KNEE GIVING OUT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017. DATE OF REVISION: UNKNOWN. DATE OF EVENT: (B)(6) 2022. LEFT KNEE. TREATMENT: REVISION COMPLETED. ALL COMPONENTS WERE REVISED.

  Patient problems: Joint Laxity

  MAUDE report 15011801 ↗
• InjuryApr 12, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14084458 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ONLY GETTING 90 DEGREES OF FLEXION SO WENT IN AND DOWNSIZED FEMUR TO INCREASE FLEXION. NO SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 13770161 ↗
• InjuryDec 29, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CREPITATION AND DISCOMFORT: PATELLA CLUNK SYNDROME EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016. DATE OF REVISION: (B)(6) 2017. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: NONE.

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

  MAUDE report 13111206 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN. SURGEON NOTED LOOSENING OF THE PFC SIGMA FEMORAL ADAPTER AND PFC SIGMA BOLT. THE BOLT BROKE AND DISASSOCIATED FROM THE ADAPTER. THE FEMUR WAS EASILY REMOVED AND THE ADAPTER WAS TURNED LOOSE. THE REMAINING BOLT WAS REMOVED FROM THE EXISTING FEMORAL SLEEVE VIA A THREADED EXTRACTOR IN THE REVISION KNEE REMOVAL SYSTEM. ALL COMPONENTS WERE REMOVED. THE SURGEON THEN SUCCESSFULLY COMPLETED CONVERTING TO A HINGE FEMUR. PATIENT HAD EXISTING TC3 REVISION CONSTRUCT IN LEFT KNEE. DOI: (B)(6) 2017, DOR: (B)(6) 2021 ,LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12437027 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BONE FRACTURE OF MEDIAL AND LATERAL FEMORAL CONDLYLES: ABNORMAL RADIOGRAPHIC EVALUATION - LIKELY FEMORAL COMPONENT LOOSENING (UNCONFIRMED), WITH FRACTURE OF THE MEDIAL AND LATERAL CONDYLES, AND INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF REVISION: (B)(6) 2017 (ALL COMPONENTS) .OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: REVISION OF THE FEMORAL AND INSERT COMPONENTS OCCURRED ON (B)(6) 2021.

  Patient problems: Fall; Joint Laxity; Limb Fracture; Pain; Swelling/ Edema

  MAUDE report 12415375 ↗
• InjuryAug 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TC3 FEMUR AND PRESSFIT STEM WERE REVISED DUE TO LOOSENING. THE FEMORAL COMPONENTS LOOSENED AND TIBIA WAS LEFT IN THE PATIENT. AFFECTED SIDE WAS THE LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 12324240 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TKA. REMOVED IMPLANTS THAT WERE IMPLANTED (B)(6) 2020. PERFORMED WASHOUT, I&D AND IMPLANTED A ANTIBIOTIC CEMENT SPACER. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 12295592 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  EXPLANTATION OF INFECTED KNEE IMPLANT. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 11984448 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, 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-0399-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527.
• 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-0398-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0523.
• 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-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-1369-04 · Dec 22, 2003 · Terminated
  P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703