SIGMA 96-0013Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10603295232025), received between Jul 24, 2017 and Mar 19, 2026 — classified as 55 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (16 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE. THE CR FEMUR WAS REMOVED AND REPLACED WITH A TC3 FEMUR AND A THICKER INSERT. THE CEMENT WAS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24637525 ↗
• InjuryJul 10, 2024Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Migration; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Migration

  SUBJECT ID: (B)(6). STUDY NO: DOTS. ASSOCIATED STUDY: ROTATING PLATFORM, ROTATING PLATFORM DATE OF EVALUATION: (B)(6) 2024. DATE OF ONSET: (B)(6) 2024. OPERATIVE SIDE: RIGHT. DIAGNOSIS: CHRONIC INFECTION. ADVERSE EVENT: INFECTION - DEEP. SPECIFY: COUNTRY: US. SERIOUS: YES. DEVICE RELATED: REMOTE POSSIBILITY PROCEDURE RELATED: REMOTE POSSIBILITY. ADDITIONAL EVENT INFORMATION: ON (B)(6) 2021, THE PATIENT WAS NOTED TO HAVE HAD A RIGHT TOTAL KNEE ARTHROPLASTY. ON (B)(6) 2022, THE PATIENT WAS NOTED TO HAVE FALLEN AND SUSTAINED A DISTAL FEMUR FRACTURE AND UNDERWENT ORIF OF THE DISTAL FEMUR FRACTURE. ON (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT HAD RIGHT KNEE PAIN, STATUS POST TOTAL KNEE REPLACEMENT AND SUBSEQUENT ORIF OF DISTAL FEMUR FRACTURE. IT WAS NOTED THAT THE PATIENT CONTINUES TO HAVE INTERMITTENT CELLULITIS SINCE THE ORIF ON (B)(6) 2022. IT WAS NOTE THAT THE PATIENT HAD INTERMITTENT CELLULITIS. THE KNEE HAD BE ASPIRATED (B)(6) 2023, WHICH SHOWED A STAPH EPIDERMIDIS INFECTION. RADIOLOGICAL REPORT NOTES THE PATIENT HAS A RIGHT TOTAL KNEE ARTHROPLASTY WITH SUBSIDENCE AND LOOSENING OF THE FEMORAL COMPONENT. THE RIGHT KNEE WAS NOTED TO HAVE CHRONIC INFECTION.

  Patient problems: Cellulitis; Pain; Unspecified Infection

  MAUDE report 19709642 ↗
• InjuryJun 4, 2024Adverse 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 PULMONARY EMBOLISMS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: ORAL MEDICATION AND CLOT REMOVALS.

  Patient problems: Inadequate Osseointegration; Pulmonary Embolism

  MAUDE report 19463161 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19447903 ↗
• 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 19144893 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISMS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: ORAL MEDICATION (ELIQUIS), CLOT REMOVALS. DEPUY PRODUCTS USED (NO REVISION COMPLETED).

  Patient problems: Pulmonary Embolism

  MAUDE report 17995287 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17107138 ↗
• InjuryMay 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION OF FEMORAL/TIBIAL COMPONENT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2017. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2023 (RIGHT KNEE). TREATMENT: REVISION; REVISED COMPONENTS UNSPECIFIED.

  Patient problems: Joint Dislocation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16919019 ↗
• InjuryApr 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR PATELLAR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2009, DATE OF REVISION: (B)(6) 2022, DATE OF EVENT: (B)(6) 2023, (LEFT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Joint Dislocation

  MAUDE report 16750784 ↗
• InjuryJan 31, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. REVISED FEMUR, TRAY AND INSERT DUE TO FEMORAL LOOSENING. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16271613 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNDISCOVERED NICKEL ALLERGY AND THIS HAD PAIN WHEN THE ORIGINAL CONSTRUCT WAS PUT IN. SURGEON TOOK IT ALL OUT AND PUT IN A COMPETITOR REVISION CONSTRUCT. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16233204 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SWELLING, HEMARTHROSIS. 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. (RIGHT KNEE). TREATMENT: ASPIRATION/DRAINAGE AND ORAL MEDICATION (CELEBREX).

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 15966110 ↗
• InjuryOct 31, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT CAME IN WITH BACK PAIN FROM WHAT HE BELIEVED TO BE FROM HIS KNEES. SURGEON REMOVED THE 3X15 AND WHILE HE WAS TAKING THE POLY OUT THE FEMUR LIFTED OFF. HE REMOVED THE FEMORAL COMPONENT, PERFORMED CLEANUP CUTS AND IMPLANTED A TC3 FEMUR, AUGMENTS, TAPERED STEM AND RPPS INSERT. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2014. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15698260 ↗
• InjurySep 28, 2022Loss of or Failure to Bond; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Migration; Loss of or Failure to Bond; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Migration

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2007; DATE OF REVISION: (B)(6) 2022; (RIGHT KNEE). TREATMENT: REVISION; FEMORAL AND TIBIAL COMPONENTS WERE REMOVED.

  Patient problems: Foreign Body Reaction; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15500601 ↗
• InjuryApr 12, 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 SWELLING : HEMARTHROSIS, EVENT IS NOT SERIOUS AND IS CONSIDERED MILD, EVENT IS REMOTE POSSIBILITY RELATED TO DEVICE AND IS REMOTE POSSIBILITY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2022; DATE OF EVENT (ONSET): (B)(6) 2022; (RIGHT KNEE). TREATMENT: KNEE ASPIRATION/DRAINAGE; ORAL MEDICATION - CELEBREX.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 14082707 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS PATIENT COMPLAINTS OF STIFFNESS AND PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 13479554 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE AVULSION BONE FRACTURE OF MEDIAL FEMORAL CONDYLE EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: SURGICAL OPEN REDUCTION INTERNAL FIXATION. ON (B)(6) 2021, THE PATIENT HAD A LEFT HYBRID TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS, END-STAGE, LEFT KNEE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WERE USED DURING THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A CLOSED MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS, STATUS POST LEFT TOTAL KNEE ARTHROPLASTY.

  Patient problems: Limb Fracture

  MAUDE report 12439389 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PULMONARY EMBOLISM. EVENT IS SERIOUS AND IS CONSIDERED MILD. 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) 2021. (RIGHT KNEE). TREATMENT: ORAL MEDICATION: (B)(6).

  Patient problems: Pulmonary Embolism

  MAUDE report 12365739 ↗
• InjuryAug 10, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE EXTENSOR INSTABILITY : LIGAMENT RUPTURE - SUBLUXATION OF THE PATELLA WITH DISRUPTED MEDIAL RETINACULUM (SLIGHT) EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2010, DATE OF EVENT (ONSET): (B)(6) 2010, (RIGHT KNEE). REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, INSTABILITY, AND FEELINGS OF POPPING AND CLICKING. UPON ENTERING THE JOINT, CLEAR FLUID, SIGNIFICANT SYNOVITIS AND PIECES OF POLYETHYLENE WERE ENCOUNTERED. THE TIBIAL POLY WAS DETERMINED TO BE FRACTURED AND WORN WITH SIGNS OF RECURRENT SUBLUXATION / SPIN-OUT. THE FEMORAL COMPONENT WAS NOTED TO HAVE MICROMOTION AND SIGNS OF EARLY LOOSENING AND THUS WAS REVISED. THE TIBIAL COMPONENT WAS ALSO REVISED WITHOUT INDICATION OF DEFICIENCY. THE PATELLA WAS LEFT INSITU. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. TREATMENT: NONE.

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

  MAUDE report 12301889 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT BILATERAL OPEN REDUCTION INTERNAL FIXATION TO ADDRESS BILATERAL PATELLA TENDON RUPTURE. THE SURGEON NOTED THE PATIENT WAS GETTING OUT OF A CHAIR AND FELT A POP IN EACH KNEE. THE PATIENT WAS UNABLE TO STAND AFTER EVENT. ON THE RIGHT SIDE, THE SURGEON NOTED A PATELLAR TENDON RUPTURE AVULSION FROM INFERIOR ASPECT OF PATELLA AND ON THE LEFT SIDE, PATELLAR TENDON RUPTURE AVULSION FORM INFERIOR ASPECT OF PATELLA AND MIDSUBSTANCE FRAYING AND MACERATION. BILATERALLY THE FOLLOWING ISSUES WERE IDENTIFIED: BRUISING/ECCHYMOSIS, EFFUSION, HEMATOMA, AND HEMARTHROSIS. THE BILATERAL RUPTURES WERE REPAIRED WITH SUTURES. NO PRODUCTS WERE REVISED OR REMOVED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

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

  MAUDE report 12169107 ↗
• InjuryJun 4, 2021Loss of or Failure to Bond; Noise, Audible; Loss of or Failure to Bond; Noise, Audible

  (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR FLEXION INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2010. DATE OF EVENT: (B)(6) 2021. (RIGHT KNEE) MEDICAL RECORD REVIEW REVEALS OFFICE NOTES (B)(6) 2021 INDICATE THE PATIENT IS EXPERIENCING PAIN, INSTABILITY, AND FEELINGS OF HER KNEE ¿CLUNKING¿. PHYSICAL EXAM REVEALS LAXITY AND FLEXION INSTABILITY. THE SURGEON INDICATES THAT THE ¿CLUNK¿ BEING FELT IS THE TIBIA SUBLUXING SLIGHTLY ON THE FEMORAL COMPONENT, NOT RELATED TO PATELLA CLUNK. THE DATABASE INDICATED THAT THE KNEE HAS NOW BEEN REVISED, ON (B)(6) 2021, TO ADDRESS INSTABILITY AND ASEPTIC LOOSENING OF THE FEMUR AT AN UNSPECIFIED INTERFACE. THE FEMUR AND TIBIAL INSERT COMPONENTS WERE REVISED--THE TIBIAL TRAY AND PATELLA WERE RETAINED.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 11939809 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUESTIONS: 1. THE HOSPITAL INDICATED IN THE DER IS UNCLEAR. PLEASE PROVIDE THE HOSPITAL/ACCOUNT WHERE THE REVISION SURGERY WAS PERFORMED. 2. IS A RESPONSE LETTER REQUESTED? IF YES, FOR WHOM? 3. CAN YOU PLEASE CONFIRM IF ALL IMPLANTS ON THE IMPLANT STICKER SHEET (FEMUR, TIBIA, INSERT AND PATELLA) WERE REVISED/EXPLANTED? IF NOT, WHAT IMPLANTS WERE REVISED? ANSWERS: (B)(6) HOSPITAL. NO LETTER. EVERYTHING WAS EXPLANTED EXCEPT FOR PATELLA.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11827247 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11716871 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MID FLEXION INSTABILITY. DOI: (B)(6) 2019 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11710714 ↗
• InjuryMar 4, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT UNDERWENT A KNEE REVISION TO TREAT LOOSENING OF THE FEMORAL COMPONENT AND TIBIAL TRAY AT AN UNKNOWN INTERFACE. THERE WAS NOTED WEAR ON THE TIBIAL INSERT AND A TIBIAL CYST. TH TIBIAL VOID WAS FILLED WITH CEMENT. DOI: 2014, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 11418198 ↗

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-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-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-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-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.