SIGMA 96-0014Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295232032), received between Aug 15, 2017 and Dec 12, 2025 — classified as 37 injuries, 2 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, K943462); 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT THE SEPTIC WASHOUT WITH SPACER PLACEMENT.

  Patient problems: Sepsis

  MAUDE report 23790783 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAINFUL KNEE AND UNDERWENT REVISION SURGERY FOR FULL REVISION. PRIMARY COMPONENTS REMOVED AND REPLACED WITH SIGMA REVISION TC3 FEMUR WITH SLEEVE AND STEM AND MBT REVISION RP TIBIAL WITH SLEEVE AND STEM. THERE WAS NO SURGICAL DELAY. DOI: UNK DATE 2012. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17730365 ↗
• InjuryJan 3, 2023Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2006. DATE OF REVISION: (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Joint Laxity; Osteolysis; Synovitis

  MAUDE report 16088890 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS AND HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2015. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: ASPIRATION OF 10ML OF BLOODY FLUID, SENT FOR SYNOVASURE.

  Patient problems: Fall; Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 16014647 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CONTINUED PAIN AND LIMITED ROM. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022.(RIGHT KNEE). TREATMENT: ASPIRATION/DRAINAGE (ASPIRATE SENT FOR SYNVASURE AND CULTURE) AND ORAL MEDICATION.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 15852001 ↗
• InjurySep 30, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  I HAVE RECEIVED A PHONE CALL FROM A HOSPITAL TODAY ASKING IF WE HAVE HAD ANY PRODUCT RECALLS FOR SIGMA. THEY INFORMED ME THAT IN A CASE IN JUNE OR JULY A PATIENT HAD A RIGHT CR FEMUR IMPLANTED INTO A LEFT LEG. THEY WOULD LIKE TO RULE OUT THE POSSIBILITY OF A PACKAGING ISSUE. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? YES NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519133 ↗
• InjuryJun 20, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED BY THE PATIENT THAT HE IS CURRENTLY IN THE WEBSITE FOR A DEPUY KNEE RECALL AND HE IS HOPING IF SOMEONE HE CAN SPEAK WITH.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Erythema; Fatigue; Hemorrhage/Blood Loss/Bleeding; Inflammation; Loss of Range of Motion; Nerve Damage; Pain; Swelling/ Edema

  MAUDE report 14743934 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2017; DATE OF REVISION: (B)(6) 2022; (RIGHT KNEE). TREATMENT: REVISION OF FEMUR, TIBIAL TRAY, INSERT, AND PATELLA.

  Patient problems: Unspecified Infection

  MAUDE report 13653342 ↗
• InjuryNov 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REVISION - REMOVED FEMUR, INSERT AND TIBIA. ARTHROFIBROSIS. NO DELAY. NO BROKEN INSTRUMENTS. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT (B)(6), WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: ARTHROFIBROSIS, DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF YES, DATE OF REVISION SURGERY. (B)(6) 2027, REASON FOR REVISION SURGERY. ARTHROFIBROSIS, PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4) DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4) DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4) DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4) DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/

  Patient problems: Adhesion(s)

  MAUDE report 12850008 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS (INCLUDING THE CROSSED OUT TIBIAL INSERT) WERE REVISED. THE REASON FOR REVISION WAS FOR FIXED FLEXION DEFORMITY. THE DATE OF ORIGINAL SURGERY WAS (B)(6) 2010. THERE WAS NO SIGN OF WEAR, THE IMPLANTS ARE NOT AVAILABLE FOR RETURN. THE SURGEON DOES NOT REQUIRE ANY FOLLOW UP.

  Patient problems: Joint Contracture; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 12054473 ↗
• InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DVT AND HEMARTHROSIS THAT RESULTED FROM BLOOD THINNING MEDICATION TO TREAT DVT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2020, DATE OF EVENT: (B)(6) 2021, (RIGHT KNEE).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 11223601 ↗
• InjuryDec 8, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS RECURRENT FEMORAL COMPONENT-RELATED HEMARTHROSIS DATE OF IMPLANTATION: (B)(6) 2007. DATE OF REVISION #1: (B)(6) 2018 (INSERT). DATE OF REVISION #2: (B)(6) 2020. (RIGHT KNEE). TREATMENT: REVISION OF FEMUR AND TIBIAL INSERT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10971397 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. THE CR PRESSFIT FEMUR AND POLY WERE REPLACED WITH A TC3 FEMUR AND FB TC3 POLY. THE ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10861286 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A 2ND STAGE REPLACEMENT WAS PERFORMED WHEN INFECTION WAS GONE. ORIGINAL IMPLANT DATE IS UNKNOWN. NO SURGICAL DELAY IS NOTED. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10485053 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE SURGEON REMOVED THE SIGMA CR FEMUR AND REPLACED IT WITH A SIGMA TC3 FEMUR. HE THEN IMPLANTED A SIGMA STAB+ INSERT ALONG WITH A NEW SIGMA OVAL DOME PATELLA. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10309308 ↗
• InjuryJul 16, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE ARTHROPLASTY, BOTH THE FEMORAL AND TIBIAL COMPONENTS TO ADDRESS ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND RECURRENT HEMARTHROSIS. DEPUY COMPONENTS INCLUDING DEPUY CEMENT WERE USED DURING THIS PROCEDURE. FEMORAL COMPONENT WAS NOTED TO BE LOOSE, BUT NO INTERFACE OF LOOSENING PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 10286119 ↗
• InjuryApr 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 IMPLANTS WERE EXPLANTED AND ABX SPACER IMPLANTED FOR (B)(6), THIS WAS ALL THE INFORMATION THEY HAVE ON THIS CASE. NTED AND ABX SPACER IMPLANTED FOR (B)(6), THIS WAS ALL THE INFORMATION THEY HAVE ON THIS CASE. DOI: (B)(6) 2017. DOI: (B)(6) 2018 (TIBIAL INSERT). DOR: (B)(6) 2020; RIGHT KNEE.

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

  MAUDE report 9957350 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA ON (B)(6) 2020.

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain

  MAUDE report 9945306 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT KNEE TO ADDRESS FLEXION INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2014; DATE OF REVISION: (B)(6) 2015; (RIGHT KNEE). TREATMENT: FEMUR AND TIBIAL INSERT REVISED

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

  MAUDE report 9813362 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN OVER TIBIA. DOI: (B)(6) 2015. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9693564 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR PULMONARY EMBOLISM. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2020; DATE OF EVENT: (B)(6) 2020; (RIGHT KNEE).

  Patient problems: Hypoxia; Respiratory Failure

  MAUDE report 9672955 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING IMPLANTS WERE REMOVED TODAY (B)(6) 2019 DURING KNEE REVISION SURGERY. THE SURGEON SAID THAT A FIXED FLEXION DEFORMITY WAS THE REASON FOR REVISION.

  Patient problems: Joint Disorder; Limited Mobility Of The Implanted Joint

  MAUDE report 9369649 ↗
• InjuryJul 29, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SIGMA FIXED BEARING KNEE WAS EXPLANTED AND A KASM CEMENT SPACER WAS PLACED. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8836491 ↗
• InjuryJul 3, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ASEPTIC LOOSENING.

  Patient problems: No Code Available

  MAUDE report 8757680 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TEAR IN THE RETINACULUM. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Injury; No Code Available

  MAUDE report 8535445 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K943462. One submission often covers many models, so check the product and lot details in each record.

• Z-1077-2014 · Dec 9, 2013 · Terminated
  PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
• Z-1686-2009 · May 7, 2009 · Terminated
  DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. The devic
• Z-0405-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650.
• Z-0402-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 2.5, 8 mm, 67mm M/L, 45 mm A/P, UHMWPE, 2.5, sterile; Product Code/REF 96-0630.
• Z-0407-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 5, 15mm, 83mm M/L, 55mm A/P, UHMWPE, sterile; Product Code/REF 96-0663.
• Z-0404-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 10mm, 71mm M/L, 47mm A/P, UHMWPE, sterile; Product Code/REF 96-0641.
• Z-0406-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651.
• Z-0403-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 8 mm, 71mm M/L, 47 mm A/P, UHMWPE, sterile; Product Code/ REF 96-0640.