SIGMA 96-0084Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295232513), received between Feb 6, 2018 and Apr 9, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI-UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24825786 ↗
• 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 24637561 ↗
• 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 24546983 ↗
• InjuryFeb 10, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF TC3 FEMUR AT BONE TO IMPLANT INTERFACE. SURGICAL DELAY IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21346805 ↗
• 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 18484722 ↗
• 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 17718597 ↗
• 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 16149548 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO TIBIA COLLAPSED ON THE MEDIAL SIDE AND CAUSED PATIENT DISCOMFORT AND INSTABILITY. THE DOCTOR REMOVED ALL COMPONENTS AND REPLACED WITH A NEW REVISION KNEE TO CORRECT PATIENTS INSTABILITY. DOI : (B)(6) 2008 DOR : (B)(6) 2022 LEFT SIDE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 13335045 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. NEW FEMUR WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12407731 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS TO CAPTURE PATIENTS¿ PRIOR REVISIONS REPORTED IN (B)(4). THIS WAS THE TENTH REVISION FOR THIS PATIENT; PATIENT UNDERWENT A LEFT PRIMARY TOTAL KNEE REPLACEMENT (TKR) ON (B)(6) 2009. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020 DUE TO TIBIAL PAIN.

  Patient problems: Pain

  MAUDE report 12168032 ↗
• 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 11887065 ↗
• InjuryApr 26, 2021Noise, Audible; Noise, Audible

  OFFICE NOTES (B)(6) 201 - (B)(6) 2019 INDICATE THE PATIENT IS EXPERIENCING SWELLING, POPPING, INSTABILITY AND PAIN OF THE LEFT KNEE. HE IS ALSO EXPERIENCING SWELLING, PAIN, NUMBNESS AND INSTABILITY IN THE RIGHT KNEE AND FEELINGS OF CRUNCHING AND CRACKING. CURRENT TREATMENT INCLUDES ORAL PAIN MEDICATION, PHYSICAL THERAPY, KNEE BRACES AND NERVE BLOCKS. NO EVIDENCE OF ADDITIONAL REVISION OF PRODUCTS. DOI: (B)(6) 2018 (TRAY - CAPTURED IN (B)(4)), DOI: (B)(6) 2019 (FEMUR, PATELLA AND INSERT - CAPTURED IN (B)(4)), DOR: NONE REPORTED, LEFT KNEE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11723851 ↗
• 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 11455589 ↗
• 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 11223471 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE AND QUADRICEPS REPAIR TO ADDRESS EXTENSOR MECHANISM RUPTURE AND INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2004, DATE OF REVISION #1: (B)(6) 2020 (POLY WEAR), DATE OF REVISION #2: (B)(6) 2020, (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Contracture; Joint Laxity; Synovitis

  MAUDE report 11176121 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND ALL IMPLANTS WERE REMOVED. THE PATIENT HAS MULTIPLE HEALTH ISSUES INCLUDING CANCER. THE PATIENT BEGAN TO HAVE AN ISSUE WITH THE KNEE APPROXIMATELY 3 MONTHS AGO AND BY THE TIME HE CAME IN, HE WAS GROSSLY INFECTED WITH A DRAINING SINUS. A STATIC SPACER WAS PLACED AFTER THOROUGH I&D. DOI: (B)(6) 2013, DOR: (B)(6) 2020, LEFT KNEE.

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

  MAUDE report 11117672 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASEPTIC REVISION OF LEFT KNEE. KNEE HAD BEEN REVISED MANY YEARS AGO AND THE FEMORAL COMPONENT WAS UNSUPPORTED BY BONE SO IN TIME THE STRESS WAS ALL ON THE BOLT AND IT FAILED. THE FEMORAL COMPONENT WAS REMOVED, THE ADAPTOR WAS REMOVED FROM THE WELL INGROWN SLEEVE AND AN SROM HINGE FEMUR WAS INSERTED INTO THE FEMORAL SLEEVE, A 12MM HINGE INSERT WAS PLACED AND THE WOUND WAS CLOSED. I WAS NOT PROVIDED WITH ORIGINAL DATE OF SURGERY SO I READ THE LOT NUMBERS AS MUCH AS POSSIBLE FROM THE REMOVED IMPLANTS.

  Patient problems: No Code Available

  MAUDE report 10800853 ↗
• 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 (B)(6) 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 10758092 ↗
• 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 10207454 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD REVISION FOR HAVING LOOSE COLLATERAL LIGAMENTS. DOI: UNKNOWN; DOR: (B)(6) 2020; LT KNEE.

  Patient problems: No Code Available

  MAUDE report 9688719 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND A DEFICIENT MLL. PATIENT HAD A TC3 MBT KNEE WITH SIZE 5 LEFT TC3 FEMUR, 5 DEFREE ADAPTOR, T2/ 2 BOLT, 10 X 75 STEM, AND MBT TC3 5 X 17.5 INSERT REMOVED AND REPLACED WITH LEFT MEDIUM NOLES HINGE, 40 FULL POROUS SLEEVE, 18 X 75 STEM AND 14X MEDIUM LPS POLY. TIBIA WAS NOT REVISED. DOI: (B)(6) 2014. DOR: (B)(6) 2019, LEFT SIDE.

  Patient problems: Joint Disorder; No Code Available; Pain

  MAUDE report 9167787 ↗
• 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 9135670 ↗
• InjurySep 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND TIBIAL TRAY AND FEMORAL COMPONENT LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED IN THE PREVIOUS OPERATION. DOI: (B)(6) 2005 (STEM); DOI: (B)(6) 2007 (FEMORAL); DOR: (B)(6) 2009.

  Patient problems: Not Applicable; Pain

  MAUDE report 7895230 ↗
• InjuryAug 14, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(4) DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION RELATED TO LOOSENING OF FEMORAL COMPONENT. DOI: (B)(6) 2009. DOR: (B)(6) 2018. (LEFT, KNEE).

  Patient problems: Joint Disorder; No Known Impact Or Consequence To Patient; Not Applicable; Pain

  MAUDE report 7780430 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RE REVISION OF KNEE ARTHROPLASTY. PATIENT CONSEQUENCE?: UNKNOWN. PATIENT CONSEQUENCE DESCRIPTION: PAIN AND DIFFICULT TO WALK. ACTION TAKEN FOR PROCEDURE: CULTURES TAKEN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Pain

  MAUDE report 7741897 ↗

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-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-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-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-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-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-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-1369-04 · Dec 22, 2003 · Terminated
  P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703