SIGMA 96-0092Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295232599), received between Nov 9, 2017 and Mar 5, 2026 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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. 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.

• InjuryMar 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT HAD PATELLAR CLUNK IN TC3 CONSTRUCT. PATELLA TISSUE WAS REVISED. POLY WAS SWAPPED FROM 17.5 TO 20. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24524412 ↗
• InjuryNov 1, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE BOLT BENT ON THE TC3 FEMORAL COMPONENT THAT WAS IMPLANTED BACK IN 2011. SURGEON CHANGED THE FEMUR TO A DISTAL FEMORAL REPLACEMENT. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THERE WAS LOOSENING OF THE FEMUR AT THE BONE TO IMPLANT INTERFACE AND BOLT/ADAPTOR. DOI: (B)(6) 2011, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15708662 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FRACTURED HER DISTAL FEMUR REQUIRING A DISTANT FEMORAL REPLACEMENT. UNKNOWN HOW THE FRACTURE OCCURRED. TOTAL REVISION OF COMPONENTS, PATELLA WAS NOT REVISED. NO PATIENT HARM AND NO EXTENDED TIME REPORTED. THERE WAS A REPORTED LOOSENING OF THE UNKNOWN COMPONENT AT THE UNKNOWN INTERFACE. ADDITIONAL INFORMATION RECEIVED IN WHICH SALES REP SPECIFIES THERE WAS NO LOOSENING OF THE COMPONENTS. JOINT LOOSENING WAS SECONDARY TO THE FRACTURE OF THE BONE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 15334753 ↗
• InjuryOct 22, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO MEDIAL INSTABILITY AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2013. DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12683143 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EXTENSOR MECHANISM DEFECT AND PREVIOUS INFECTION. SHE WAS LEFT WITH SOME LAXITY AND NEEDED A THICKER POLY AFTER THE SYNOVECTOMY AND REPAIR. NO LOOSENING OF COMPONENTS REPORTED. DOI: (B)(6) 2017, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11916359 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE DOCTOR DECIDE TO REMOVE ALL COMPONENTS DO TO THIS INFECTION. IT WAS ALSO REPORTED THAT A FEMORAL IMPACTOR TIP BROKE OFF DURING THIS SURGERY. A COMPETITOR CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 11780392 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT KNEE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2014; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11517115 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: NOT INDICATED/UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11142675 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, SYNOVITIS, TIBIAL INSERT WEAR, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN MANUFACTURER PRODUCTS WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED DURING THE REVISION. IT IS NOTED, AT THE END OF THE PROCEDURE, THE SURGEON REPORTED AN INTRAOPERATIVE DISTAL FEMORAL FRACTURE EXTENDING ABOUT 10 CM PROXIMALLY. THE FRACTURE WAS TREATED WITH 4 CERCLAGE WIRES AND NOTED TO BE STABLE. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, SWELLING, AND INFECTION. THE TIBIAL INSERT WAS EXCHANGED AND THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2020, 5-WEEK POST-OPERATIVE VISIT INDICATED SIGNIFICANT EFFUSION OF THE LEFT KNEE WITH MILD ERYTHEMA BUT NO OVERAL WARMTH. AFTER REVISION, THE PATIENT RECEIVED IV ANTIBIOTICS VIA A PICC LINE. THE PATIENT'S CRP WERE STILL ELEVATED COMPARED TO NORMAL, BUT WERE CONTINUING TO TREND DOWN. THIS PC CAPTURES THE EFFUSION AND IV ANTIBIOTICS ON (B)(6) 2020.

  Patient problems: Edema; Erythema; No Code Available

  MAUDE report 9748851 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, SYNOVITIS, TIBIAL INSERT WEAR, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN MANUFACTURER PRODUCTS WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED DURING THE REVISION. IT IS NOTED, AT THE END OF THE PROCEDURE, THE SURGEON REPORTED AN INTRAOPERATIVE DISTAL FEMORAL FRACTURE EXTENDING ABOUT 10 CM PROXIMALLY. THE FRACTURE WAS TREATED WITH 4 CERCLAGE WIRES AND NOTED TO BE STABLE. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, SWELLING, AND INFECTION. THE TIBIAL INSERT WAS EXCHANGED AND THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2020, 5-WEEK POST-OPERATIVE VISIT INDICATED SIGNIFICANT EFFUSION OF THE LEFT KNEE WITH MILD ERYTHEMA BUT NO OVRAL WARMTH. AFTER REVISION, THE PATIENT RECEIVED IV ANTIBIOTICS VIA A PICC LINE. THE PATIENT'S CRP WERE STILL ELEVATED COMPARED TO NORMAL, BUT WERE CONTINUING TO TREND DOWN. THIS PC CAPTURES THE INTRAOPERATIVE FEMUR FRACTURE ON (B)(6) 2014.

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

  MAUDE report 9748783 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON CONVERTED TC3 TO LPS DISTAL FEMUR DUE TO MCL DEFICIENCY AFTER A FALL. FEMUR AND FEMORAL ADAPTER AND BOLT WERE PUT IN 2015; INSERT WAS PLACED IN 2018. DOI: 2015 (FEMUR AND FEMORAL ADAPTER AND BOLT) AND 2018 (INSERT); DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9548509 ↗
• InjuryAug 23, 2019Noise, Audible; Noise, Audible

  CLINICAL ADVERSE EVENT RECEIVED FOR SCAR TISSUE LIMITING FLEXION: ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT THERE IS A REMOTE POSSIBILITY IT IS RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017; DATE OF EVENT: (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Adhesion(s); Joint Disorder; Loss of Range of Motion; No Code Available; Pain; Scar Tissue; Synovitis

  MAUDE report 8925485 ↗
• InjuryAug 20, 2019Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK COMPLAINING OF ¿PATELLAR CLUNK¿. THE SURGEON OPTED TO EXCHANGE THE POLY WHILE REMOVING DEBRIS. DOI: (B)(6) 2017. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8911769 ↗
• MalfunctionMay 8, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT WHILE ASSEMBLING THE REVISION COMPONENT (PARTS LISTED BELOW) THE LATERAL POSTERIOR AUGMENT COMBO FAILED TO SCREW/LOCK INTO THE FEMORAL TC3 COMPONENT. AFTER MULTIPLE ATTEMPTS BY 2 EXPERIENCED PEOPLE, A SECOND AUGMENT WAS OPENED; THIS AUGMENT ALSO FAILED TO LOCK INTO THE FEMORAL COMPONENT. WITH BOTH PIECES, WHEN THEY ATTEMPTED TO TORQUE THE SCREW WITH THE TORQUE WRENCH, THE AUGMENTS LIFTED AWAY FROM THE FEMUR. DISTAL AUGMENTS WERE PLACED PRIOR TO THE ATTEMPTED PLACEMENT OF THE POSTERIOR AUGMENTS AS IS CUSTOMARY. THE CONCLUSION WAS THAT THE THREADS IN THE FEMORAL COMPONENT WERE NOT RIGHT. ONE OF THE POSTERIOR AUGMENTS WAS SUBSEQUENTLY CEMENTED ONTO THE FEMUR AND THE ENTIRE COMPONENT WAS CEMENTED INTO THE PATIENT. ALL OTHER AUGMENTS 3 ADDITIONAL WERE ASSEMBLED IN THE NORMAL FASHION. THE STEM ALSO WENT ON WITH NO ISSUES. THERE WAS A SURGICAL DELAY OF 15 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 8592701 ↗
• InjuryOct 31, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN, SYNOVITIS AND LOOSENING OF THE FEMUR AND TIBIA AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available; Pain

  MAUDE report 8023646 ↗
• InjuryFeb 16, 2018Noise, Audible; Noise, Audible

  CLINICAL ADVERSE EVENT RECEIVED FOR PATELLAR CLUNK. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. ARTHROSCOPY PERFORMED, EVENT IS CONSIDERED RESOLVED. DOI: (B)(6) 2017. DOE: (B)(6) 2018; (RIGHT KNEE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7276356 ↗
• InjuryNov 14, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS UNSTABLE IMPLANTS AND FEMORAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE, CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 7029531 ↗
• InjuryNov 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS NICKEL ALLERGY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7016609 ↗

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-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-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-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-0389-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 8.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0440.
• 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-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-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-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-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-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-0385-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0 mm, 2.5, sterile; Product Code/REF 96-0430.
• 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.
• Z-0386-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 10.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0431.
• 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.

…and 9 more.