SIGMA 96-0004Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10603295231967), received between Aug 10, 2017 and Jun 4, 2026 — classified as 44 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (12 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING. IT WAS STATED THAT FEMUR WAS LOOSE. LOOSENING INTERFACE WAS UNKNOWN. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25395261 ↗
• InjuryApr 30, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO TOTAL KNEE REVISION LOOSE IMPLANTS AND PAIN. ACTIVITY LEVEL - YES. DOI:(B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 25050352 ↗
• InjuryOct 24, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION OF KNEE-TEP LEFT SIDE BECAUSE PAIN. X-RAY AND CT FINDINGS UNCLEAR. DURING REVISION FRACTURE OF POSTERIOR LATERAL FEMORAL CONDYLE WAS OBVIOUS.

  Patient problems: Limb Fracture; Pain

  MAUDE report 20522153 ↗
• 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: Joint Laxity; Unspecified Infection

  MAUDE report 19144845 ↗
• InjuryMar 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO TIBIAL AND FEMORAL LOOSENING AT THE UNKNOWN INTERFACE. DOI: (B)(6) 2012 DOR: (B)(6) 2024 AFFECTED SIDE : LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18962767 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION:(B)(6) 2021. DATE OF EVENT: (B)(6) 2023 (LEFT KNEE). TREATMENT: SYNVASURE AND LAB TESTS NEGATIVE FOR INFECTION.

  Patient problems: Pain

  MAUDE report 16852497 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FAILING SUPPRESSION AND DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION #1: (B)(6) 2020. DATE OF REVISION #2: UNK. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Erythema; Inflammation; Joint Laxity; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16195202 ↗
• InjuryDec 13, 2022Adverse 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 POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022, DATE OF EVENT: (B)(6) 2022 (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

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

  MAUDE report 15966302 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFC SIGMA CURVED LEFT CEMENTED. INSERT BROOKEN ON THE BACK DUE TO WEAR. LOSENING OF TIBIA. METALOSE.

  Patient problems: Discomfort; Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 15681084 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASING PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2015, DATE OF EVENT: (B)(6) 2022, (LEFT KNEE). TREATMENT: AWAITING INTERVENTION; AWAITING RESULTS OF SYNOVASURE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15328861 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022, DATE OF EVENT: (B)(6) 2022, (LEFT KNEE). TREATMENT: ASPIRATION/DRAINAGE; BLOODY, CLOUDY FLUID WAS EXTRACTED AND SENT FOR SYNOVASURE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15293131 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR PE. 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 KNEE. TREATMENT: INJECTED MEDICATION (HEPARIN DRIP).

  Patient problems: Discomfort; Erythema; Pain; Pulmonary Embolism

  MAUDE report 15029236 ↗
• InjuryApr 25, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO ASEPTIC LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 14196075 ↗
• InjuryJan 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR IT BAND TENDINITIS. EVENT IS SERIOUS. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: AWAITING A SURGICAL IT BAND RELEASE.

  Patient problems: Inflammation; Joint Laxity; Muscle/Tendon Damage; Pain; Swelling/ Edema

  MAUDE report 13315264 ↗
• InjuryNov 4, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY REPORTED AND THE PATELLA WAS AN IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 12750689 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS HAD A REVISION OF LEFT TOTAL KNEE AS TREATMENT TO ADDRESS ASEPTIC LOOSENING OF THE TIBIAL TRAY. THE LOOSENING WAS IDENTIFIED DURING THE INTERIM PRE-OP EVALUATION. DOI (B)(6) 2018: PATIENT RECEIVED A LEFT KNEE PRIMARY SIGMA TKA TO TREAT PRIMARY END-STAGE OA WITH VARUS DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 3 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. CLINIC NOTE DATED (B)(6) 2021: PATIENT REPORTS INTERMITTENT SWELLING, PAIN, AND LOSS OF RANGE OF MOTION IN THE LEFT KNEE OVER THE LAST YEAR. PHYSICAL EXAM CONFIRMS SWELLING AND WARMTH, AS WELL AS A REDUCTION IN LEFT KNEE EXTENSION. X-RAYS INDICATE STRESS SHIELDING AROUND THE LEFT TIBIAL COMPONENT, WHICH IS PROGRESSIVE FROM LAST FILM DATED 2018. SURGEON PERFORMS AN ASPIRATION OF 70 CCS FROM THE LEFT KNEE TO RELIEVE THE PRESSURE AND SENDS THE FLUID IN FOR A SYNOVASURE TEST TO DETERMINE IF THERE IS INFECTION PRESENT. OF NOTE: THE PATIENT HAS NOT BEEN SEEN FOR QUITE SOME TIME FOR HIS KNEE DUE TO MULTIPLE SPINAL SURGERIES. ALL RADIOGRAPHIC IMAGES WERE COMPARED WITH THE LAST FILMS DONE AROUND THE TIME OF THE PRIMARY TKA IN 2018. PHONE CALL DATED (B)(6) 2021: SYNOVASURE

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12682269 ↗
• InjuryOct 21, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE SURGERY TIME WAS NOT EXTENDED. FEMORAL LOOSENING LIKELY CAUSED BY AVN AND OVERDOSING PER SURGEON COMMENTS.

  Patient problems: Insufficient Information; Necrosis

  MAUDE report 12672477 ↗
• InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISE DUE TO PAIN. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12604804 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISTAL INCISIONAL WOUND, SUPERFICIAL VS DEEP. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017. DATE OF REVISION: (B)(6) 2021 (ADDRESSED IN (B)(4)). DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: DEBRIDMENT OF DEVASCULARIZED TISSUE AND SMALL SUTURE REMOVED. CLEANSED WITH PEROXIDE, THE PT IS ALREADY ON ANTIBIOTICS.

  Patient problems: Wound Dehiscence

  MAUDE report 12586511 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS BAD RANGE OF MOTION. PATIENT HAD NEVER BEEN SATISFIED WITH KNEE SINCE THE ORIGINAL OPERATION. NO SURGICAL DELAY. DOI: (B)(6) 2011, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 12466656 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT HAD A BILATERAL CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS BILATERAL OSTEOARTHRITIS. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA WERE USED DURING THE PROCEDURE. ON (B)(6) 2017, THE PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS ACUTE HEMATOGENOUS SEPSIS. THE RIGHT KNEE WAS ALSO ASPIRATED. PRIOR TO SURGERY, THE PATIENT WAS NOTED TO HAVE PAIN. THE PATIENT WAS NOTED TO HAVE HAD A PRIOR ASPIRATION AND WAS POSITIVE FOR INFECTION. ON (B)(6) 2021, THE PATIENT HAD A REVISION OF ALL COMPONENTS, LEFT TOTAL KNEE ARTHROPLASTY, TO ADDRESS CHRONIC INFECTION. THE TIBIAL INSERT WAS REVISED. PRIOR TO SURGERY THE PATIENT WAS NOTED TO HAVE PAIN, SWELLING, DISCOMFORT, EFFUSION, AND RECURRENT INFECTION. THE PATIENT IS HAVING A STAGE 1 REVISION FOR INFECTION NOW. ALL COMPONENTS WERE NOTED TO BE WELL FIXED PRIOR TO REMOVAL. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015. DATE OF REVISION #1: (B)(6) 2017 (INSERT). DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE).

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

  MAUDE report 11871409 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2021: CLINICAL POST-OP VISIT, BILATERAL KNEE REPLACEMENTS: SEEN BY PHYSICIAN'S ASSISTANT IN OFFICE. PATIENT PRESENTED WITH FEELING OF "GIVING OUT" AND "TAPPING" IN KNEES. IN PHYSICAL EXAMINATION, THE RIGHT KNEE DEMONSTRATED 2MM OF VARUS AND VALGUS LAXITY, WHICH SUGGESTED GLOBAL INSTABILITY. THE RIGHT KNEE WAS CAPTURED IN (B)(4). THE LEFT KNEE WAS DETERMINED TO HAVE QUADRICEPS WEAKNESS, REQUIRING PHYSICAL THERAPY ONLY. PLAN WAS FOR PHYSICAL THERAPY ON BOTH KNEES, AND TO HAVE PATIENT RETURN TO BE SEEN BY ATTENDING PHYSICIAN, AND DISCUSS POSSIBLE RIGHT KNEE REVISION TO INCREASE THICKNESS OF THE TIBIAL INSERT. DOI: (B)(6) 2020 DATE OF EVENT (ONSET): (B)(6) 2021 LEFT KNEE.

  Patient problems: Fatigue; Joint Laxity

  MAUDE report 11753526 ↗
• InjuryFeb 26, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11388879 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS FEMORAL OSTEOLYSIS. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: FEMUR AND TIBIAL INSERT REVISED. ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2019, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS PAIN, DISCOMFORT, EDEMA, INSTABILITY, WALKING DIFFICULTY, AND OSTEOLYSIS. PRE-OPERATIVELY THE SURGEON SUSPECTED FEMORAL COMPONENT WAS LOOSE, HOWEVER, THE REVISION OPERATIVE NOTE CONFIRMED THE FEMORAL COMPONENT WAS WELL-FIXED. THE SURGEON NOTED MINIMAL BONE LOSS TO THE FEMUR. THE TIBIAL INSERT AND FEMORAL COMPONENT WERE REVISED. THE TIBIAL TRAY AND PATELLAR COMPONENT WERE RETAINED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 11371973 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD NO FLEXIBILITY, SO THE DOCTOR REMOVED THE FEMUR AND PUT A NEW ONE ON. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. NO LOOSENING AND SURGICAL DELAY NOTED. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 11201025 ↗

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-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-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-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-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-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.