SIGMA 96-0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295231950), received between Nov 8, 2017 and Apr 1, 2024 — classified as 43 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THE INSERT WAS REVISED IN ALL SELECTED CASES AND AS A RETRIEVAL IMPLANT SERVED FOR THE WEAR ANALYSIS. GENERALLY, IN REVISIONS DUE TO PJI, THE CONDUCTED PROCEDURE WAS BASED ON TIME FRAME FROM INFECTION-RELATED CLINICAL SYMPTOMS ONSET AND REVISION SURGERY. DEBRIDEMENT AND IMPLANT RETENTION (DAIR) WITH INSERT EXCHANGE WAS PERFORMED FOR TIME-FRAMES LESS THAN 3 WEEKS, WHILE ONE- OR TWO-STAGE REVISION TOTAL KNEE ARTHROPLASTY WAS PERFORMED FOR LONGER TIME-FRAMES. LOOSE AND/OR GROSSLY MALPOSITION COMPONENTS WARE ALWAYS REVISED-EXCHANGED. MALALIGNMENT TKA AND INSTABILITY CASES UNDERWENT REVISION OF ALL COMPONENTS. IN CASES WHERE MULTIPLE POSSIBLE CAUSES FOR TKA FAILURE WERE IDENTIFIED ALMOST ALWAYS UNDERWENT REVISION OF ALL COMPONENTS. WITHIN THE GROUP OF OTHER ISOLATED CAUSES, ONE CASE INVOLVING PATELLOFEMORAL PAIN UNDERWENT INSERT EXCHANGE AND IMPLANTATION OF PATELLAR COMPONENT. ANOTHER CASE IN THIS GROUP UNDERWENT FEMORAL COMPONENT REVISION (PROXIMALISATION DUE TO LACK OF EXTENSION).

  Patient problems: Inadequate Osseointegration; Insufficient Information; Joint Laxity; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19012996 ↗
• InjuryJul 25, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO FEMORAL LOOSENING OF KNEE DUE TO A FALL. DOI- (B)(6) 2011. DOR- (B)(6) 2023. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Fall

  MAUDE report 17390731 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17363433 ↗
• InjuryJun 6, 2023No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO CLUNK. DATE OF IMPLANT: (B)(6) 2016. DATE OF REVISION: (B)(6) 2023. (LEFT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071065 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR MCL TEAR. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16545534 ↗
• InjuryFeb 1, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR LEFT KNEE IN 2011. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PFCS FEMUR NONPOROUS COMPONENT IN QUESTION LOOSENED. THE REVISION SURGERY WAS DONE ON (B)(6) 2023. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH OVER 30MINUTES DELAY. THE SURGEON SUGGESTED THAT THE SURFACE ROUGHNESS OF THE CEMENTED SURFACE OF THE IMPLANT WAS INSUFFICIENT. HE ALSO COMMENTED THAT CEMENTING TECHNIQUE AND IMPLANT PLACEMENT AT THE TIME MIGHT ALSO BE A FACTOR.

  Patient problems: Insufficient Information

  MAUDE report 16277603 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO VERY STIFF KNEE. SYNOVECTOMY AND FEMORAL REVISION WERE PERFORMED. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 15752408 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LEFT PFC SIGMA CR FIXED BEARING KNEE FOR INSTABILITY. NO INFORMATION REGARDING PRIMARY SURGERY NO INFORMATION REGARDING HOSPITAL, SURGERY DATE OR SURGEON REGARDING PRIMARY SURGERY. NO INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15437844 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. DIRECT EXCHANGE WAS DONE. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15365358 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI- (B)(6) 2003. DOR- (B)(6) 2022. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14205659 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTED KNEE. THE SURGEON DID AN EXPLANT AND I&D WITH ANTIBIOTIC SPACER. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14014509 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SUPERFICIAL WOUND BREAKDOWN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022 ; DATE OF EVENT: (B)(6) 2022; (LEFT KNEE). TREATMENT: IV ANTIBIOTICS, IRRIGATION AND DEBRIDEMENT.

  Patient problems: Erythema; Unspecified Infection; Wound Dehiscence

  MAUDE report 13840842 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS PERIPROSTHETIC DISTAL SUPRACONDYLAR FEMUR FRACTURE - DEGLOVING INJURY. DATE OF IMPLANTATION: (B)(6) 2005. DATE OF REVISION: (B)(6) 2021. (LEFT KNEE) TREATMENT: FEMUR, TIBIAL TRAY, AND INSERT COMPONENTS REVISED. ON (B)(6) 2005, THE PATIENT HAD A LEFT CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS, END-STAGE WITH SIGNIFICANT ARTHROFIBROSIS. DEPUY COMPONENTS INCLUDING DEPUY PATELLA WERE USED IN THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LEFT PERIPROSTHETIC SUPRACONDYLAR FEMUR FRACTURE. THE PATIENT HAD A FALL AND WANTED TO HAVE SIGNIFICANT OSTEOPOROSIS. THE SURGEON OBSERVED A DISPLACED AND SLIGHTLY COMMINUTED SUPRACONDYLAR FEMUR FRACTURE AND A DEGLOVING INJURY TO THE SUBCUTANEOUS TISSUE PROXIMAL MEDIAL TIBIA AND LARGE SUBCUTANEOUS HEMORRHAGE. THE TIBIAL TRAY, INSERT AND FEMORAL COMPONENTS WERE REVISED. COMPETITOR COMPONENTS WERE PLACED, ALONG WITH DEPUY CEMENT DURING THIS PROCEDURE.

  Patient problems: Fall; Limb Fracture; Unspecified Tissue Injury

  MAUDE report 12854572 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC TRIAGE RECEIVED AND REVIEWED INDICATED THAT ON (B)(6) 2021, THE PATIENT HAD BILATERAL CEMENTED TOTAL KNEE ARTHROPLASTIES TO ADDRESS PRIMARY OSTEOARTHRITIS, END-STAGE, BILATERAL KNEES. DEPUY COMPONENTS WERE USED, INCLUDING DEPUY PATELLA AND DEPUY CEMENT. THE MEDICAL RECORDS FROM (B)(6) 2021, NOTE THAT THE PATIENT WAS STATUS POST BILATERAL TOTAL KNEE REPLACEMENT. TOTAL KNEE REPLACEMENTS ARE NOTED TO BE DOING WELL. A CLINICAL TRIAGE SHEET NOTED THAT THE PATIENT¿S DAUGHTER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH SMALL PE X2 IN RIGHT LUNG. NO DATE WAS PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 12364606 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  ON (B)(6) 2021, THE PATIENT UNDERWENT A BILATERAL TOTAL KNEE REPLACEMENTS. DEPUY PFC SIGMA KNEES WERE IMPLANTED BILATERALLY. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. 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: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12174116 ↗
• InjuryJul 6, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ASEPTIC LOOSENING OF SIGMA SIZE 3 CR FEMUR. ENTIRE KNEE WAS REVISED TO ATTUNE REVISION. LEFT. I WAS NOT PROVIDED THE LOT #S . THE TIBIA WAS REVISED ON (B)(6) 2017.

  Patient problems: Insufficient Information

  MAUDE report 12123455 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2012, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: FEMUR AND TIBIAL INSERT REVISED.

  Patient problems: Joint Laxity

  MAUDE report 11840939 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER WAS IMPLANTED. DOI: (B)(6) 2017; DOR: (B)(6) 2020; LEFT KNEE.

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

  MAUDE report 11142798 ↗
• InjuryDec 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE AD 16 NOV 2020: REVIEW OF MEDICAL RECORDS FROM RELATED COMPLAINT ((B)(4)): UPDATE: MEDICAL RECORDS RECEIVED AD 16 NOV 2020 WERE REVIEWED ON 20 NOV 2020 BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. PRIMARY OPERATIVE NOTES 12/16/2008 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION NOTES 08/07/2010 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION OF THE TIBIAL INSERT DUE TO TIBIAL SOFT TISSUE ABSCESS AND CHRONIC LEFT TOTAL KNEE JOINT INFECTION, SWELLING AND PAIN. UPON ENTERING THE KNEE JOINT, CLOUDY FLUID AND ABNORMAL FIBROUS TISSUE WAS ENCOUNTERED AND REMOVED. THE INSERT WAS REVISED AND A DRAIN WAS PLACED. PROCEDURE NOTES 12/18/2018 INDICATE THE PATIENT RECEIVED AND IRRIGATION AND DEBRIDEMENT WITH PLACEMENT OF A WOUND VAC AND ANTIBIOTIC BEADS DUE TO A PERI-ARTICULAR INFECTED CYST, PAIN AND SWELLING OF THE LOWER LEFT LEG. IT IS INDICATED BY THE SURGEON THAT THERE IS NO CONNECTION OR COMMUNICATION TO THE KNEE JOINT. NO PRODUCTS WERE REVISED, THE KNEE JOINT WAS NOT ENTERED. OFFICE NOTES 11/04/2020 INDICATE THE PATIENT IS BEING SEEN

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Inflammation; Muscular Rigidity; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 10942238 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ABSCESS BELOW HER GASTROC FLAP. EVENT IS SERIOUS AND IS CONSIDERED MILD. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE, AND IT IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2008, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: AWAITING CONSULTATION/PROBABLE SURGICAL INTERVENTION.

  Patient problems: Abscess; Pain; Swelling/ Edema

  MAUDE report 10931640 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SUPERFICIAL INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DOI: (B)(6) 2010, DOE: (B)(6) 2018, (LEFT KNEE). TREATMENT INCLUDES IRRIGATION AND DEBRIDEMENT.

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

  MAUDE report 10931569 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GLOBAL INSTABILITY OF THE LEFT KNEE EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: AWAITING REVISION SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Fall; Joint Laxity; Pain

  MAUDE report 10905671 ↗
• InjurySep 30, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  SIGMA LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES PAIN, INJURIES, LOOSENING OF THE IMPLANT, BONE LOSS, DECREASED RANGE OF MOTION AND DIMINISHED MOBILITY. LITIGATION DID NOT SPECIFY THE LOOSE COMPONENT AND LOOSENING INTERFACE. ON (B)(6) 2011, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY WITH IMPLANTATION OF DEPUY PRODUCTS. THE STICKER SHEET FOR PRODUCTS IMPLANTED DURING THE PRIMARY OPERATION CAN BE FOUND ON PAGE 1015 OF THE ATTACHED MEDICAL RECORDS. THE CEMENT USED DURING THE PRIMARY OPERATION IS NOT GIVEN IN THE AVAILABLE MEDICAL RECORDS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, BAKER¿S CYST, STIFFNESS, DECREASED RANGE OF MOTION, FEMORAL COMPONENT LOOSENING AT AN UNKNOWN INTERFACE, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2017. LEFT KNEE.

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

  MAUDE report 10606463 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF REVISION: (B)(6) 2020, (LEFT KNEE). TREATMENT: EXPLANTATION OF FEMUR, TIBIAL TRAY, TIBIAL INSERT, AND PATELLA PRODUCTS, WITH PLACEMENT OF AN ANTIBIOTIC SPACER.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10563554 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BLOOD CLOTS TO LEG AND LUNGS : VASCULAR - PULMONARY EMBOLUS AND DVT. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO BOTH DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (LEFT KNEE).

  Patient problems: No Code Available; Pulmonary Embolism; Thrombosis

  MAUDE report 9683314 ↗

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-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-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-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.