SIGMA 96-0005Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10603295231974), received between Jul 12, 2017 and Jan 14, 2026 — classified as 51 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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. 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED DUE TO INFECTION. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24071889 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION FOR PAIN & INSTABILITY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23393574 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ARTICLE ENTITLED ¿3D POLYETHYLENE WEAR ANALYSIS AFTER PRIMARY CRUCIATE-RETAINING TKA FAILURE USING OPTICAL SCANNING AND CAD MODELS REFERENCES¿ WRITTEN BY MATEJ VALIC, VESNA LEVA¿IC, INGRID MILO¿EV, MATEJA BLAS, EVA PODOV¿OVNIK, JAKA KOREN, AND RIHARD TREB¿E WAS REVIEWED. OUR PURPOSE WAS TO IDENTIFY (A) WHETHER VOLUMETRIC WEAR (ADJUSTED FOR TIME IN-SITU) SIGNIFICANTLY DIFFER AMONG GROUPS OF COMMON CAUSES OF TKA FAILURE, (B) WHETHER THERE IS A CHARACTERISTIC WEAR DISTRIBUTION PATTERN FOR A COMMON CAUSE OF TKA FAILURE, AND (C) WHETHER NOMINAL INSERT SIZE (SMALL VS LARGE) AND COMPONENTS SIZE RATIO (FEMUR-TO-INSERT) INFLUENCE ON VOLUMETRIC WEAR RATES. THE STUDY INCLUDED PATIENTS THAT HAD BEEN IMPLANTED WITH A SIGMA TKA (CEMENTED TIBIAL TRAY AND POROUS COATED FEMORAL COMPONENT). WITHIN THE PATIENT THAT MET THE CRITERIA, THERE WERE NOTED TO BE 86 REVISION CASES DUE TO FAILURE (NO MENTION OF WHY). 59/86 TIBIAL INSERTS WERE RETRIEVED. 2 OF THE 59 INSERTS EXHIBITED INEXPLICABLE ABNORMAL TYPE OF DAMAGE AND WERE EXCLUDED FROM THE FINAL ANALYSIS. FINAL COHORT INCLUDED 57 INSERTS. THERE WAS NO MENTION OF CEMENT MFG OR PATELLA IMPLANTS. RESULTS: 86 REVISIONS. ONLY 5 PATIENTS HAD A SINGLE DETECTED

  Patient problems: Unspecified Infection

  MAUDE report 19144861 ↗
• InjuryApr 16, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED, THAT PATIENT WAS REVISED, DUE TO LOOSE OF FEMUR AND PATELLA. IT WAS UNKNOWN, WHETHER THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2002, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19117444 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER SURGERY ON (B)(6) 2020, PATIENT COMPLAINS OF STIFF JOINT ((B)(6) 2021). NO IMPROVEMENT IN JOINT STIFFNESS AFTER MOBILIZATION UNDER ANESTHESIA ((B)(6) 2021). PATIENT COMPLAINS OF SWELLING AFTER A FALL ((B)(6)2022). (B)(6) 2022 INFECTION IS DETECTED. EXPLANATION OF KNEE PROSTHESIS ON (B)(6) 2022 AND IMPLANTATION OF CEMENT SPACER. REVISION OPERATION ON (B)(6) 2022.

  Patient problems: Fall; Muscular Rigidity; Swelling/ Edema; Unspecified Infection

  MAUDE report 18411967 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: DOI: (B)(6) 2014: PATIENT RECEIVED BILATERAL SIGMA TKAS TO TREAT OSTEOARTHRITIS. BILATERAL PATELLAS WERE RESURFACED AND UNKNOWN CEMENT WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOE: (B)(6) 2023: PATIENT PRESENTS TO CLINIC WITH EFFUSION, PAIN, GRINDING SENSATIONS, WALKING DIFFICULTY, AND CREPITUS OF THE LEFT KNEE. PHYSICAL EXAM IDENTIFIES 1 MM LAXITY AND CONFIRMS WALKING DIFFICULTY, EFFUSION, AND SYNOVITIS. X-RAYS IDENTIFY A STABLE KNEE WITH A VERY THIN LUCENCY UNDER THE ANTERIOR FLANGE. THE PATIENT IS REFERRED FOR EXPLORATORY SURGERY TO IDENTIFY THE SOURCE OF THE SYNOVITIS AND CREPITUS. THERE WERE NO INDICATIONS THAT THE PROCEDURE HAS BEEN COMPLETED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Swelling/ Edema; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 17351143 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RECURRENT HEMARTHROSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2014. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; REVISED COMPONENTS NOT SPECIFIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17154399 ↗
• InjuryMar 8, 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

  REVISION OF A PFC TKR DONE IN 2006. MALE, LEFT SIDE. ON THE JOINT REGISTRY FORM, THE REASON FOR REVISION WAS DUE TO DEEP INFECTION, TIBIAL LOOSENING, FEMUR LOOSENING. WHEN EXPOSURE WAS DONE THE SURGEON NOTED SIGNIFICANT POLY WEAR AS SEEN IN THE PICS. ALL COMPONENTS WERE REMOVED AND ATTUNE REVISION WAS IMPLANTED. DOI: (B)(6) 2006. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16502360 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST OP MI. EVENT IS 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 AND LEFT KNEE). TREATMENT: ORAL MEDICATION (PLAVIX).

  Patient problems: Myocardial Infarction

  MAUDE report 16193821 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16142393 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SIGMA RP TOTAL KNEE IMPLANT IN 2018. THE PATIENT HAD ONE WASHOUT BETWEEN NOW AND THEN. THE PATIENT WAS CONFIRMED FOR INFECTION AND THE TOTAL KNEE WAS REMOVED AND THE INFECTION IS BEING TREATED WITH ANTIBIOTIC SPACER AND RE-IMPLANT WILL OCCUR WHEN THE INFECTION CLEARS. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16022880 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED KNEE, DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018; DATE OF REVISION: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022; (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, PATELLA, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16015588 ↗
• InjuryDec 15, 2022Fracture; Fracture

  SURGEON IS REPORTING A FRACTURE OF A KNEE-TEP´S FEMORAL CONDYLE. DOI: UNKNOWN. DOR: (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15985998 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED SWELLING/ LARGE EFFUSION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2014; DATE OF EVENT: (B)(6) 2022; (LEFT KNEE). TREATMENT: ASPIRATION/DRAINAGE (SENT FOR SYNOVASURE).

  Patient problems: Swelling/ Edema

  MAUDE report 15121631 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANTERIOR PAIN POST FALL, HEMARTHROSIS EVENT IS NOT SERIOUS AND IS CONSIDERED MILD THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2004 DATE OF EVENT (ONSET): (B)(6) 2022 (LEFT KNEE) TREATMENT: ASPIRATED PREPATELLAR BURSA WITHOUT ANY PURULENT FLUID. PATIENT IS ALSO ON XARELTO SO A BLEED IS LIKELY.

  Patient problems: Cellulitis; Fall; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 14399712 ↗
• InjuryMar 23, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS ASEPTIC LOOSENING. DATE OF IMPLANTATION: (B)(6) 2015. DATE OF REVISION: (B)(6) 2022. LEFT KNEE. TREATMENT: REVISION OF FEMUR, TIBIAL TRAY, TIBIAL INSERT, AND PATELLA.

  Patient problems: Ambulation or Postural Difficulties; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 13868801 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR COMPLETE WOUND BREAKDOWN WITH EXTENSOR MECHANISM EXPOSED, FOUL SMELLING. UNSURE IF THIS COMMUNICATES WITH THE JOINT OR NOT AT THIS POINT. WOUND DEHISCENCE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. LEFT KNEE. TREATMENT: PICC LINE FOR IV ANTIBIOTICS, REFERRED TO PLASTICS FOR GASTROC FLAP COVERAGE.

  Patient problems: Fluid Discharge; Impaired Healing; Necrosis; Wound Dehiscence

  MAUDE report 13824632 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR QUAD TENDON TEAR VS DISRUPTION OF MEDIAL ARTHROTOMY : PAIN, SEVERE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF EVENT (ONSET): (B)(6) 2022; (LEFT KNEE). TREATMENT: CERCLAGE REPAIR OF PATELLAR TENDON AND DISRUPTED CAPSULAR ARTHROTOMY.

  Patient problems: Loss of Range of Motion; Muscle/Tendon Damage; Pain; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 13440016 ↗
• InjuryOct 21, 2021Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn

  PATIENT HAD LOOSENING ON BOTH THE TIBIAL AND FEMORAL COMPONENTS. PATIENT HAD A PRIMARY SIGMA FB CR CONSTRUCT IN. BOTH HAD TOO MUCH WEAR (BEEN IN PATIENT ~20 YRS) AND CEMENT TO MAKE OUT EXACT PRODUCT # AND LOT # BUT THOUGHT TO BE A SZ 5 FEMUR AND 4 OR 5 TIBIA WITH A 10 MM INSERT. PATELLA WAS LEFT IN AND NOT REVISED. DOI: UNKNOWN. DOR: UNKNOWN. UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 12672444 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT A PRIMARY BILATERAL KNEE ARTHROPLASTY. DEPUY PRODUCTS WERE USED FOR EACH KNEE. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT PRESENTED FOR A LEFT KNEE EVALUATION DUE TO HEMARTHROSIS, EFFUSION, SWELLING, DISCOMFORT, AND DECREASED RANGE OF MOTION. A LEFT KNEE ARTHROCENTESIS WAS PERFORMED AND 60 ML OF BLOODY SYNOVIAL FLUID WAS REMOVED. IV ANTIBIOTICS WERE ALSO ADMINISTERED. THERE WERE NO INDICATED COMPLICATIONS.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 12525723 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE NOT LOOSENED. THEY WERE WELL FIXED TO THE BONE. THEY WERE REMOVED DUE TO INFECTION. DOI: (B)(6) 2013, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 12219661 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND EXPERIENCED INSTABILITY IN THE KNEE. THE DOCTOR REPLACED THE FEMUR, TIBIA AND INSERT WITH NEW COMPONENTS TO STABILIZE THE KNEE. DOI: (B)(6) 2013, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 12215380 ↗
• InjuryJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS REVISED FOR COMPLAINTS OF PAIN WITH SUSPECTED INFECTION, NOT BEING CONFIRMED INTRAOPERATIVELY.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 12180182 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LACK OF FLEXION AND EXCESSIVE SCAR TISSUE. NO SURGICAL DELAY. DOI: (B)(6) 2003; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 11879362 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PAIN AND LOOSENING OF AN UNKNOWN COMPONENT HAS OCCURRED AGAIN. DEPUY CEMENT PRODUCTS WERE USED. THE DOCTORS ARE TRYING TO FIND OUT WHETHER THERE IS A POSSIBLE ALLERGY TO ONE OF THE COMPONENTS OF THE BONE CEMENT USED. THE DERMATOLOGIST/ALLERGIST NEEDED THE QUALITATIVE COMPOSITION COMPONENTS OR AT LEAST SAMPLES OF THE BONE CEMENT POWDER OR BONE CEMENT LIQUID FOR AN ALLERGY TEST. ON (B)(6) 2019, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY WITH IMPLANTATION OF DEPUY UNICONDYLAR SLED PROTHESIS TO TREAT OSTEOARTHRITIS. DEPUY CEMENT WAS UTILIZED DURING THE PROCEDURE. THE PATELLA WAS NOT RESURFACED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS PAIN, ADHESION, CYSTS, CREPITUS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. ALL COMPONENTS WERE REMOVED, AND THE PATELLA WAS RESURFACED. . ON (B)(6) 2021, A LEFT KNEE X-RAY REVEALED OSTEOLYSIS BENEATH THE TIBIAL PLATEAU. ON (B)(6) 2021, A LEFT KNEE CT REVEALED POSSIBLE TIBIAL TRAY LOOSENING. ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT KNEE ASPIRATION TO RULE OUT INFECTION DUE TO INCREASING PAIN. THE PHYSICIAN ASPIRATED 1

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

  MAUDE report 11618932 ↗

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-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-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-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.