SIGMA 96-0012Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295232018), received between Aug 13, 2018 and Sep 16, 2024 — classified as 12 injuries, 1 malfunction.

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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS: IS THIS EVENT RELATED TO THE STUDY DEVICE? NOT RELATED. IS THIS EVENT RELATED TO THE STUDY PROCEDURE? REMOTE POSSIBILITY. DATE OF EVENT: (B)(6) 2024. ADDITIONAL EVENT INFORMATION: CLINIC NOTE ADDED: (B)(6) 2024. ON (B)(6) 2024, MEDICAL RECORDS NOTE, THE PATIENT IS FOUR YEARS POST RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT WAS NOTED, TO HAVE ARTHROFIBROSIS KNEE WITH PAIN AND STIFFNESS. THE PATIENT HAD A SCAR TISSUE SURGERY WITH OPEN RESECTION, POLY SWAP IN THE PAST. THE PATIENT THEN FELL AND HAD REGRESSION AND RETURN OF ARTHROFIBROSIS. THE PATIENT HAS INCREASED PAIN, DIFFICULT TIME WITH MOBILITY. AN ASPIRATION OF KNEE WAS PERFORMED. AND NEGATIVE FOR ANY TIME OF BACTERIAL INFECTION. THE SURGEON SUGGESTED, TOTAL KNEE ARTHROPLASTY REVISION FOR ARTHROFIBROSIS.

  Patient problems: Adhesion(s); Fall; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 20223278 ↗
• InjuryOct 12, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS WERE RECEIVED AND REVIEWED BY THE CLINICIAN: ON (B)(6) 2023, THE PATIENT UNDERWENT A RIGHT KNEE REVISION SECONDARY TO PAIN, SWELLING, AND INSTABILITY AFTER A FALL. XRAYS INDICATE LOOSENING WITH VALGUS COLLAPSE OF THE FEMORAL COMPONENT. INTRA-OPERATIVELY, THE FEMORAL SUBSIDENCE AND LOOSENING WERE CONFIRMED, THOUGH A LOOSENING INTERFACE WAS NOT PROVIDED. MILD WEAR WAS NOTED ON THE PATELLAR COMPONENT, THOUGH IT WAS NOT REVISED.

  Patient problems: Discomfort; Fall; Insufficient Information; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17919835 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN. EVENT IS CONSIDERED MILD. UNKNOWN IF EVENT IS CONSIDERED SERIOUS. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2012. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: CT SCAN FOR EVALUATION OF INTERFACES.

  Patient problems: Pain

  MAUDE report 17885098 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXERCISING AND TORE HER PCL WHICH MADE HER CURRENT IMPLANT UNSTABLE. THE FEMORAL COMPONENT WAS REMOVED AND A POSTERIOR STABILIZED FEMUR WAS IMPLANTED ALONG WITH A POSTERIOR STABILIZED POLY. THE KNEE WAS STABLE FROM FLEXION TO FULL EXTENSION. THE TIBIAL TRAY WAS STABLE AND THE PATELLA WERE STABLE SO THEY WERE LEFT INTACT. DOI- (B)(6) 2012. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16378484 ↗
• InjuryAug 18, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN RESULTING FROM FEMORAL COMPONENT SUBSIDENCE AND ASEPTIC LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2014; DATE OF EVENT: (B)(6) 2022; DATE OF REVISION: (B)(6) 2022; (RIGHT KNEE). TREATMENT: REVISION; REMOVAL OF THE FEMORAL COMPONENT AND INSERT.

  Patient problems: Fall; Osteolysis; Pain; Synovitis

  MAUDE report 15249164 ↗
• InjuryJul 8, 2022Noise, Audible; Migration; Noise, Audible; Migration

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN RESULTING FROM FEMORAL COMPONENT LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2014; DATE OF EVENT: (B)(6) 2022; DATE OF REVISION: UNK; RIGHT KNEE. TREATMENT: REVISION OF THE FEMORAL COMPONENT AND INSERT.

  Patient problems: Ambulation or Postural Difficulties; Fall; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 14955211 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT HAD AN EXCISION OF NODULAR FAT JUST ABOVE THE PREPATELLAR BURSA WITH REMOVAL OF MULTIPLE ETHIBOND SUTURES, RIGHT KNEE. THE BURSA HAD BECOME PAINFUL. THE SURGEON REPORTED FINDING NODULAR FATTY TISSUE JUST ABOVE THE PREPATELLAR BURSA, WHICH WAS CREATING SOMEWHAT OF A BAND ACROSS THE BURSA. THAT WAS THE MAIN ISSUE. THE SURGEON ALSO REMOVED MULTIPLE ETHIBOND SUTURES. DOI: (B)(6) 2016. DOE: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Inflammation; Pain

  MAUDE report 12211423 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS EXTENSIVE SCARRING OF THE EXTENSOR MECHANISM TO THE DISTAL FEMUR : ADHESIONS. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF REVISION: (B)(6) 2020; (RIGHT KNEE). TREATMENT: TIBIAL INSERT WAS REVISED.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11176109 ↗
• InjuryJan 5, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS ASEPTIC LOOSENING OF FEMUR AND PATELLA COMPONENTS DATE OF IMPLANTATION: (B)(6) 2016; DATE OF REVISION: (B)(6) 2020; (RIGHT KNEE). TREATMENT: FEMUR, TIBIAL INSERT, AND PATELLA COMPONENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Muscular Rigidity; Osteolysis; Pain; Synovitis

  MAUDE report 11120289 ↗
• MalfunctionMar 26, 2019Use of Device Problem; Use of Device Problem

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS / ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DOI: (B)(6) 2012; DOE: (B)(6) 2019; (RIGHT KNEE). NO TREATMENT AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Fibrosis; Joint Disorder; Loss of Range of Motion; Pain

  MAUDE report 8451417 ↗
• InjuryFeb 28, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL RADIOGRAPHIC EVALUATION - RESORPTION AND EARLY LOOSENING OF THE FEMORAL COMPONENT, PERSISTENT PAIN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DOI: (B)(6) 2016; DOE: (B)(6) 2019, (RIGHT KNEE). NO TREATMENT AT THIS TIME.

  Patient problems: No Code Available; Pain

  MAUDE report 8377936 ↗
• InjuryJan 28, 2019Adverse 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 FULL KNEE REVISION.

  Patient problems: No Code Available; Pain

  MAUDE report 8281647 ↗
• InjuryAug 13, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING AT CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2011; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7776473 ↗

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-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.
• 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-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-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.