Tab LegendsGeneral InformatiomSFMEA Info : Inputs and OutputsDFMEA Info : Inputs and OutputsShared S / DFMEA OutputPFMEA Info : Inputs and OutputsShared S / D / PFMEA OutputsReference

APQP ProcessBasic APQP Tool MethodologyIntegrationPrototype Control PlanSystem / Asm. / Comp. "Tuning"Prelim. / Final B.O.M.Preliminary ProcessPrelim. / Final Dwgs.map developed.S/DFMEA- Core team developed.- Define System / Asm. / Component"Non-optimal""Functional blocks".- Perform Functional block analysis.- Develop System / Asm. / Component DFMEA.- Existing Process Capability review. DFM / DFA Required??Technical Review.- Extract Fault trees (if required).Sys./Asm./Comp.- Develop "Critical Characteristics" listing.Diagnostics inputto service manual."Acceptable"PFMEA- Core team developed.- Process "mapping" reviewed and updated."Non-optimal"Proposed mfg. tooling requirements.("Poke-Yoke")- Process functional block analysis.- Develop Process FMEA.Develop operator- Develop design and process "Criticalinstructions.Technical Review.Characteristics" listing."Acceptable"PRE LAUNCH CONTROL PLAN- Q.E. , MFG. Team.- Review critical characteristics listing.- Generate Plan:- Items.- Frequency.- SPC controls (as required).- Develop Insp. Tooling Requirements.Technical Review."Automated / non-automated"?Decision made.(Review "P.O." and "Severity" criteria.)- Calibration Requirements and FrequencyGAGE R & R- Q.E. , D.E. , MFG. Team.- Identify target Tooling / equipment.- Define the frequency analysis is to be performed.Technical Review.- Conduct and record R&R results."Acceptable"Prelim. Prod. ProcessCapability Assessments (FTC)Process Technical Review ."Acceptable"Sign-offFINAL PROCESS CONT. PLANTechnical Review.Production Validation"Acceptable"Production Release.Ongoing Production ProcessContinuous ImprovementCapability AssessmentsEfforts.

I've heard of the APQP process , show me where FMEA figures in to the scheme of things.

Case StudyAPQP andFMEA ProcessCase Study :Hip Socket ReplacementIUSB2/01 - 11/02

System ConsiderationsSystem ConsiderationsRegulatory InputsDesign ConsiderationsSystem InputsFunctional BlockSystem FMEAFault TreesDesign Verification Plan & Report

Regulatory InputsMEDICAL DEVICE REGULATIONS 21 CFR Part 888 Table of Contents (Index)Parent PageDevice Advice HomeDevice Advice Assistance & HelpDSMA HomeCDRHHomeFDA HomeFDA SearchCDRH Comments21 CFR Part 888Code of Federal Regulations Online via GPO Access. (This page last updated: April 16, 1998)PART 888 - ORTHOPEDIC DEVICESTop of pageSubpart A - General ProvisionsSec.888.1 Scope.888.3 Effective dates of requirement for premarket approval.888.5 Resurfacing technique.888.6 Degree of constraint.888.9 Limitations of exemptions from section 510(k) of the act.Subpart B - Diagnostic Devices888.1100 Arthroscope.888.1240 AC-powered dynamometer.888.1250 Nonpowered dynamometer.888.1500 Goniometer.888.1520 Nonpowered goniometer.Subpart C - [Reserved]Subpart D - Prosthetic Devices888.3000 Bone cap.888.3010 Bone fixation cerclage.888.3015 Bone heterograft.888.3020 Intramedullary fixation rod.888.3025 Passive tendon prosthesis.888.3027 Polymethylmethacrylate (PMMA) bone cement.888.3030 Single/multiple component metallic bone fixation appliances and accessories.888.3040 Smooth or threaded metallic bone fixation fastener.888.3050 Spinal interlaminal fixation orthosis.888.3060 Spinal intervertebral body fixation orthosis.888.3100 Ankle joint metal/composite semiconstrained cemented prosthesis.888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.888.3120 Ankle joint metal/polymer non-constrained cemented prosthesis.888.3150 Elbow joint metal/metal or metal/polymer constrained cemented prosthesis.888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.888.3200 Finger joint metal/metal constrained uncemented prosthesis.888.3210 Finger joint metal/metal constrained cemented prosthesis.888.3220 Finger joint metal/polymer constrained cemented prosthesis.888.3230 Finger joint polymer constrained prosthesis.888.3300 Hip joint metal constrained cemented or uncemented prosthesis.888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.888.3320 Hip joint metal/metal semi-constrained, with a cementedacetabular component, prosthesis.888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.888.3340 Hip joint metal/composite semi-constrained cemented prosthesis.888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.888.3360 Hip joint femoral (hemi-hip) acetabular metallic cemented or uncemented prosthesis.888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis.888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.888.3410 Hip joint metal/polymer semi-constrained resurfacing cemented prosthesis.888.3480 Knee joint femorotibial metallic constrained cemented prosthesis.888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis.888.3500 Knee joint femorotibial metal/composite semi-constrained cemented888.3510 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained prosthesis.888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis.888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.888.3720 Toe joint polymer constrained prosthesis.888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.888.3750 Wrist joint carpal lunate polymer prosthesis.888.3760 Wrist joint carpal scaphoid polymer prosthesis.888.3770 Wrist joint carpal trapexium polymer prosthesis.888.3780 Wrist joint polymer constrained prosthesis.888.3790 Wrist joint polymer constrained prosthesis.888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.Subpart E - Surgical Devices888.4150 Calipers for clinical use.888.4200 Cement dispenser.888.4210 Cement mixer for clinical use.888.4220 Cement monomer vapor evacuator.888.4230 Cement ventilation tube.888.4300 Depth gauge for clinical use.888.4540 Orthopedic manual surgical instrument.888.4580 Sonic surgical instrument and accessories/attachments.888.4600 Protractor for clinical use.888.4800 Template for clinical use.888.5850 Nonpowered orthopedic traction apparatus and accessories.888.5890 Noninvasive traction component.888.5940 Cast component.888.5960 Cast removal instrument.888.5980 Manual cast application and removal instrument.WAIS Document Retrieval[Code of Federal Regulations][Title 21, Volume 8, Parts 800 to 1299][Revised as of April 1, 2000]From the U.S. Government Printing Office via GPO Access[CITE: 21CFR888.3300][Page 459]TITLE 21--FOOD AND DRUGSSERVICES--(Continued)PART 888--ORTHOPEDIC DEVICES--Table of ContentsSubpart D--Prosthetic DevicesSec. 888.3300 Hip joint metal constrained cemented or uncemented prosthesis.(a) Identification. A hip joint metal constrained cemented oruncemented prosthesis is a device intended to be implanted to replace ahip joint. The device prevents dislocation in more than one anatomicplane and has components that are linked together. This generic type ofdevice includes prostheses that have components made of alloys, such ascobalt-chromium-molybdenum, and is intended for use with or without bonecement (Sec. 888.3027). This device is not intended for biologicalfixation.(b) Classification. Class III.(c) Date PMA or notice of completion of a PDP is required. A PMA ora notice of completion of a PDP is required to be filed with the Foodand Drug Administration on or before December 26, 1996 for any hip jointmetal constrained cemented or uncemented prosthesis that was incommercial distribution before May 28, 1976, or that has, on or beforeDecember 26, 1996 been found to be substantially equivalent to a hipjoint metal constrained cemented or uncemented prosthesis that was incommercial distribution before May 28, 1976. Any other hip joint metalconstrained cemented or uncemented prosthesis shall have an approved PMAor a declared completed PDP in effect before being placed in commercialdistribution.[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]

&L&"Arial,Bold"&14Regulatory Inputs

Design Considerationswww.medmedia.com/o14/52.htmWheeless' Textbook of Orthopaedics Main Menu Home PageCemented Femoral Stems:- See: Total Hip Replacement Menu:- Cemented Femoral Component: Loosening:- Collar: in THR- Optimal Cementing Technique- Removal of Cemented Femoral Stems:- Indications:- cemented femoral stems probably remain gold standard for total hip arthroplasty;- most indicated in older patients (more than 65 yrs), but are also used in younger patients since there is some indicationsthat cemented stems are less prone to develop osteolysis;- useful for patients w/ "stove pipe" type femur, previous fracture, or previous osteotomy since thesepatients would not be expected to achieve a tight fit which is necessary for ingrowth;- may be indicated poor bone quality such as RA, osteoporosis, or Paget's disease;- outcomes:- in the study by JJ Callaghan MD et al (J Bone Joint Surg [Am] 82-A: 487-97, 2000) the authors followed Charnley Total Hip Arthroplastypatients (with cement) with a minimum 25 year follow up;- of the 327 hips for which the outcome was known after a minimum of 25 years, 295 (90 %) had retained the original implants untilthe patient died or until the most recent follow-up examination;- of the 62 hips in patients who lived for at least 25 years after the surgery, 48 (77 %) had retained the original prosthesis;- Cemented Component Design:- prosthesis should have relatively smooth surfaces, w/ no sharp edges, so that sites of stress concentration are eliminated from both prosthesis and cement;- a prosthesis that is broader laterally than medially may help to diffuse the compressive stress medially;- cobalt-chromium alloy stems are used in most stems, since they generate less particulate debris than titanium implants;- Component Surface:- there is controversy about how much bonding should occur between the cement and the femoral stem;- excessive bonding between the cement and stem may transfer wt bearing stress to the bone-cement interface, leading to loosening;- in contrast, excessive motion between the cement-metal interface, may lead to excessive osteolysis and rapid loosening;- some are proponents of smooth surface, which may allow subsidence and thereby keeps the cement in compressive loading;- many components have a matt finish, which allows some mechanical interlock with the cement;- in the study by DW Howie et al (JBJS Vol 80-B, 1998), 4/20 matt coated stems had been revised for aseptic loosening whereas 0/20 polished stems had beenrevised (9 year minimum follow up);- references:- Loosening of matt and polished cemented femoral stems. DW Howie et al. JBJS. Vol 80-B. No 4. July 1998 p 573.Influence of Cement Technique on the Interface Strength of Femoral ComponentsMichael F. Shepard, MD J. Michael Kabo, PhD Jay R. Lieberman, MDCORR 2000;2000:26-35The optimal surface finish for polymethylmethacrylate cemented femoral components remainscontroversial. Concerns about early debonding of the prosthesis-cement interface have ledsurgeons to use roughened surfaces to enhance the cement-prosthesis bond.However, loosening of roughened stems is associated with the generation of excessive weardebris. The purpose of the current study was to determine whether the time to cementationinfluenced the cement-prosthesis bond of four roughened cobalt chrome surfaces (60 grit-blasted,10 grit-blasted, 10 grit-blasted with polymethylmethacrylate precoating, glass bead-blasted)and one polished cobalt chrome surface. Fixation strength was assessed using mechanicalpushout and tensile testing. Roughened and polymethylmethacrylate precoated surfaces hadsignificantly greater tensile and shear strengths at early cementation times compared withpolished surfaces. However, roughened components had significant decreases in tensile andshear strengths as cementation time increased from 2 to 4 minutes and 2 to 6 minutes.In contrast, tensile and shear strengths for the polished surface were significantly lowerthan for the roughened surfaces and did not change with longer cementation times.When using a roughened or precoated cemented femoral component, the surgeon should considercementing earlier with wetter cement to maximize the cement-prosthesis bond.When implanting a polished femoral component, it is preferable that the cement is doughy,because the cement-prosthesis bond is not influenced by the wetness of the cement and itis easier to maintain the orientation of the femoral component.- Cement Mantle:- current recommendations are to have at least 2 mm of a uniform cement mantle around the femoral component;- in the study by RP Joshi et al (JBJS Vol 80-B, 1999), the authors found that a 3 mm cement mantle around the femoral component, and a6 mm mantle around the acetabular component were associated with the lowest incidence of osteotlysis;- references:- Changes in the calcar femoris in relation to cement technology in total hip replacement.F Bocco et al. COOR. Vol 128. 1977. p 287-295.- The cement mantle in total hip arthroplasty. Analysis of long-term radiographic results.- Osteolysis after Charnely primary low friction arthroplasty. A comparison of two matched paired groups.RP Joshi et al. JBJS Vol 80-B. No 4. July 1998. p 585.- Grading of Cement Technique: (Barrack et. al. JBJS 1992 and Mulroy et.al. 1995)- grade A: meduallary canal completely filled w/ cement (white out).- grade B: a slight radiolucency exists at the bone cement interface.- grade C: a radiolucency of more than 50% at the bone cement interface.- grade D: a radiolucency involving more than 100% of the interface between bone and cement in any projection, including absence of cement distal to the stem tip;- note: this grading system has been criticized since it is somewhat influenced by the amount of cancellous bone removed during reaming and broaching;- when the entire cancellous bed is removed, there will often be "white out" (indicating good cementing technique), and yetthere will be no cancellous foothold for the cement;- cement mantle:- as noted by Mulroy et.al. 1995, a femoral cement mantle less than 1 mm and defects in the cement mantle are associated with early loosening;- Jasty et al 1990, noted that cement voids and stem abutment against the femur (indicating an inadequate cement mantel) were associated w/ loosening;- similarly, Maloney et al 1990, note that circumferential cement mantles with component centralization prevents loosening;- references:- Bone lysis in well fixed cemented femoral components. Maloney WJ et al, JBJS Vol 72-B. 1990. p 966-970.

&L&"Arial,Bold"&16Design Considerations

SFMEAInputsKeyEnvironmentKeyRegulatoryKeyCustomer Wants / NeedsE1Temperature :NAR1FDA 21 CFR Part 888C1Warranted 10 years : non-fatigue in intervalE2Vibration :NAC2Easily installed (Easily formed ; adjustable)E3Mech. Shock :NAC3Various sizes to choose from (L&R)E4Mech. Load :200#C4Clean , Dry , Finished as receivedE5Altitude :NAC5Volume : 10,000 / yearE6Corrosive :C6Std. Pack : 28 / case (each hermeticallyE7Foreign Material :Dust ,sealed in own bag)E8Humidity :0% - 100%C7Free from shipment damageE9Fluids :Alcohol ,C8Low WeightE10Elec. Load :NAC9Cost : $450.00/pieceE11EMC / RFI :NAC10HypoallergenicE12ESD :NAC11 :Weight : < 7 oz.E13Other :NOTE : Titanium cost = $100.00 / pound$43.75KeySeverity TableClassification4Non Compliance to Reg. RequirementsKeyUse when :Hazard to End UserCCSev = 43Extreme Customer DissatisfactionSCSev < 4 & RPN >/= 60Loss of function2Cleanliness IssuesCustomer Delay Issues1No Effect"More than 120,000 - 160,000 artificial hip joints are being implanted annually in the United States."David G. Murray, M.D.Panel and Conference ChairpersonProfessor and ChairmanDepartment of Orthopedic SurgeryState University of New York Health Sciences CenterSyracuse, New York"Because the medical community has been asked to become increasingly fiscally responsible, cost analysis is being applied to every aspect of health caredelivery. When evaluating the expenditures associated with total hip arthroplasty, attention has been concentrated on implant costs. The United States marketfor hip and knee implants is approximately $1.6 billion annually with a range in price of a primary total hip prosthesis between $2,000 and $6,000. With Medicarepaying for 59 percent of all total hip replacements in 1994, the Diagnosis Related Group (DRG) payment method predominates the reimbursement for this procedure.The DRG method reimburses a hospital a fixed fee for a primary total hip replacement, approximately $9,000. The DRG payment covers the cost of the implant anddoes not vary with the amount of money spent for the implant.In general, if we are searching for an inexpensive DRG stem, then a cemented stem must be chosen.Porous cementless stems currently do not have low-priced options. In fact, the most expensive cemented stem is about the same price as the least expensiveporous cementless stem. The average price of a cemented stem is $1,537 with a range from $400 to $2,150, while cementless stem prices average $2,656 with a rangefrom $2,130 to $3,450. The first option in choosing a low-priced cemented implant is selecting the material type and manufacturing method. Implants fall into twobasic manufacturing methods; casting and forging. Forging is more expensive, but results in a stronger, more fatigue resistant stem. For example, a forgedchromium-cobalt stem has, on average, 50 percent more tensile and fatigue strength than a cast chromium-cobalt stem."Richard A. Berger, MD, is adult reconstruction fellow, department of orthopaedicsurgery, Rush Medical College, Chicago.Joshua J. Jacobs, MD, is associate professor, of orthopaedic surgery, RushMedical College, Chicago."The operation usually takes 2 to 4 hours."

&L&"Arial,Bold"&14System Inputs

System Functional BlockDesign Functional Block DiagramDisplay or list:DFMEA No.:Page1of1Design Supvr. :ClassPhysical interfacing hardware.Rev. Lvl.:Rev. Date:Design Engr.:ClassPotential interfering hardwareProj.HI1Customer:AnyReliability Eng.:ClassFasteners & attachments ("Fi").Year:2001Date:Operational Environment Extremes :Show blocks not part of the analysisSystem / Item Name :Hip ImplantReference applicable internal/customer test spec. and section number.in this fashion:Temperature :NACorrosive:ASTM B117EMC/RFI :NALevel :Line Legend :Hydraulic /Vibration:NAForeign Mat'l.:NAESD:NASystemMechanical:Electrical :Pneumatic :Shock:NAHumidity:0% - 100%Other 1Applicable .Federal/Local Regulation(s):Mech . Load:1200 #Fluids :Alcohol,Other 2FDAAltitude:NAElec. Load:NAEng. Spec.:LegendA1Pelvic FlangeA2Socket ReplacementPelvic FlangeF1 (1 Place)A3Pelvic Bone FlangeA4Polyethylene LinerA5Femoral Ball ReplacementF1Threaded AttachmentF2F2Crimp AttachmentHip BoneF3Cement AttachmentSocketF4Slip FitF1 (5 Places)F3 ( 2 Places)F3F4PelvicBoneF1 (6 Places)Design Functional Block DiagramDisplay or list:DFMEA No.:Page1of1Design Supvr. :ClassPhysical interfacing hardware.Rev. Lvl.:Rev. Date:Design Engr.:ClassPotential interfering hardwareProj.HI1Customer:AnyReliability Eng.:ClassFasteners & attachments ("Fi").Year:2001Date:Operational Environment Extremes :Show blocks not part of the analysisSystem / Item Name :Hip ImplantReference applicable internal/customer test spec. and section number.in this fashion:Temperature :NACorrosive:EMC/RFI :NALevel :Line Legend :Hydraulic /Vibration:NAForeign Mat'l.:NAESD:NASystemMechanical:Electrical :Pneumatic :Shock:Humidity:0% - 100%Other 1Applicable .Federal/Local Regulation(s):Mech . Load:Fluids :Alcohol,Other 2FDAAltitude:NAElec. Load:NAEng. Spec.:

&L&"Arial,Bold"&16System Functional Block&L.A1A2A3A4A5

Feature Func Analysis MatrixFeatureFunctionCustomer Wants & NeedsRegulatory RequirementsEnvironmentStrengthLoad bearingC1,C8R1E1,E4Size & ConfigurationAdaptable to patient sizeC3R1FinishCosmetic , hypoallergenic ,C4,C10R1E7,E8,E9bonding surface , lubricating surface ,corrosion resistanceA1 : Pelvic Flange (upper)Provide mounting and attachmentC1,C3R1E1,E4interface to upper pelvic bone flange.Positions/locates and retains F1 (1 place).C1,C3R1E1,E4Easily installed.C2,C3R1A2 : Socket Replacement CupProvide mounting and attachmentC1,C3R1E1,E4interface to pelvic bone socket.Positions/locates and encapsulatesC1,C3R1E1,E4A4.Recieves ,supports and provides mountingC1,C3R1E1,E4interface to A5.Positions/locates and retains F1 (5 places).C1,C3R1E1,E4Provides reactant (bonding)Interface with F3.Easily installed.C2,C3R1A3 : Pelvic Flange (lower)Provide mounting and attachmentC1,C3R1E1,E4interface to lower pelvic bone flange.Positions/locates and retains F1 (6 places).C1,C3R1E1,E4Easily installed.C2,C3R1A4 : Polyethelyene LinerProvides mounting interface to A2 and A5.C1,C3R1E1,E4Provides wear surface between A2C1,C3R1E1,E4and A5.Provides attachment & sealing interfaceC1R1E1,E4to A2. Provides reactant (bonding)Interface with F3.Minimizes frictional wear at A2 to A5C1R1E1,E4interface.Hypoallergenic.C4,C10R1E7,E8,E9Easily installed.C2,C3R1A5 : Femoral Ball ReplacementProvides mounting interface (F5)C1,C3R1E1,E4to A2 and A4.Withstands corrosive influences.C4R1E7,E8,E9Provides mounting and attachmentC1,C3E1,E4interface to femoral stem.Smooth finish.C1R1E1,E4Load bearing.C1,C3R1E1,E4Easily installed.C2,C3R1F1 / F2 : Threaded attachmentProvides mounting interface to A1,A2 andC1,C3R1E1,E4A3.Secures A1,A2,A3 to respectiveC1,C3R1E1,E4Pelvic bone joints.Hypoallergenic.C4,C10R1E7,E8,E9Withstands corrosive influences.C4E7,E8,E9Smooth finish.C1R1E1,E4Load bearing.C1,C3R1E1,E4Easily installed.C2,C3R1F3 : CementSecures A2 to femoral bone socket (2 places).C1R1E1,E4Retains A4 to A2 over uniform surface.C1R1E1,E4Hypoallergenic.C4,C10R1E7,E8,E9Load bearing. Provides strength to femoralC1R1E1,E4bone.Withstands corrosive influences.C4E7,E8,E9Easily installed.C2F4 : Slip fitAllows multi-axial loading , rotationC1R1E1,E4between A2 and A5.

&L&"Arial,Bold"&14System Feature - Function Analysis

SFMEAPotentialFailure Mode and Effects AnalysisSystemFMEA Number12345678ComponentPrepared ByClassProcessDesign ResponsibilityClassFMEA Date (Orig.)3/7/01Model Year(s)/Project01 Hip Socket ReplacementKey Date4/1/01FMEADate (Rev.)NACore Team :ClassAction ResultsDesign Item-Process Function/Design Function-Process Requirements*Potential Failure ModePotential Effect(s) of FailureSevClassPotential Cause(s)/ Mechanism(s) of FailureOccurPrevention (Preventive Controls)Current System Design Controls (Detective Controls)DetecRPNRecommended Action(s)Responsibility & Target Completion DateActions TakenSevOccDetRPNA1 : Pelvic Flange (upper) :Provide mounting and attachment interface to upper pelvic bone flange.Yield / Fatigue of attachment interfaceLoss of function. Extreme physical discomfort and customer dissatisfaction.3Dimensional Incompatability (DI) (A1).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.212No further design action. SPC attachment configuration.MW 4/01/01.PCR#1 adds inspection requirements.3Materials Incompatability (MI) (A1).2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability.212No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.3SCImproper installation procedure followed.5Note in procedural manual.Not Applicable.10150Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01. No further action.Positions/locates and retains F1/F2 (1 place).DisplacedLoss of function. Extreme physical discomfort and customer dissatisfaction.3Dimensional Incompatability (DI) (A1).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.212No further design action. SPC attachment configuration.MW 4/01/01.PCR#1 adds inspection requirements.3Dimensional Incompatability (DI) (F1/F2 to A1).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.212No further design action. SPC attachment configuration.MW 4/01/01.PCR#1 adds inspection requirements.3Materials Incompatability (MI) (A1 to F1/F2).2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability.212No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.3SCImproper installation procedure followed (Torque on F1/F2).5Note in procedural manual.Not Applicable.10150Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01. No further action.Easily installed.Not easily installed.Excessive installation time.2SCDimensional Incompatability (DI) (improper device configuration used).5Note in procedural manual. Maintainability Simulation.Not Applicable.10100Forward concern to customer. Distinct containers and labeling.MW 4/01/01.Forwarded on 3/12/01. ECR#23165 specifies package configuration. No further action.2SCImproper installation procedure followed .5Note in procedural manual.Not Applicable.10100Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01. No further action.A2 : Socket Replacement Cup : Provide mounting and attachment interface to pelvic bone socket.Yield / Fatigue of attachment interfaceHazard to end user.4CCDimensional Incompatability (DI) (A2).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.216No further design action. SPC attachment configuration.MW 4/01/01.PCR#1 adds inspection requirements.4CCMaterials Incompatability (MI) (A2).2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability.216No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.4CCPhysiochemical Instability (PI) (To Cement Materials F3).3Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability.Fluids Compatability Test.224No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.4CCDimensional Incompatability (DI). (F1)2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.216No further design action. SPC attachment configuration.MW 4/01/01.PCR#1 adds inspection requirements.4CCMaterials Incompatability (MI). (F1)3Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability.224No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.4CCImproper installation procedure followed (F1 Torque ; Wrong A2 configuration used).5Note in procedural manual.Not Applicable.10200Forward concern to customer. Distinct containers and labeling.MW 4/01/01.Forwarded on 3/12/01. ECR#23165 specifies package configuration. No further action.Positions/locates and encapsulates A4.DisplacedLoss of function. Extreme physical discomfort and customer dissatisfaction.3Dimensional Incompatability (DI).(A2 )2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.212No further design action. SPC attachment configuration.MW 4/01/01.PCR#1 adds inspection requirements.3SCImproper installation procedure followed (Wrong A2 configuration used;Wrong A4 configuration used).5Forward concern to customer. Note in procedural manual.Not Applicable.10150Forward concern to customer. Distinct containers and labeling.MW 4/01/01.Forwarded on 3/12/01. ECR#23165 specifies package configuration. No further action.3Dimensional Incompatability (DI).(A4 )2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.212No further design action. SPC attachment configuration.MW 4/01/01.PCR#1 adds inspection requirements.Provide mounting /support and attachment interface to A5.DisplacedLoss of function. Extreme physical discomfort and customer dissatisfaction.3Dimensional Incompatability (DI).(A2 to A5 )2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.212No further design action. SPC attachment configuration.MW 4/01/01.PCR#1 adds inspection requirements.3Materials Incompatability (MI) (A2/A5).2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability.212No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.3SCImproper installation procedure followed (Wrong A2/A5 configuration used).5Note in procedural manual.Not Applicable.10150Forward concern to customer. Distinct containers and labeling.MW 4/01/01.Forwarded on 3/12/01. ECR#23165 specifies package configuration. No further action.Positions/locates and retains F1 (5 places).DisplacedLoss of function. Extreme physical discomfort and customer dissatisfaction.3Dimensional Incompatability (DI).(A2 to F1 )2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.212No further design action. SPC attachment configuration.MW 4/01/01.PCR#1 adds inspection requirements.3Materials Incompatability (MI) (F1).2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability.212No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.3SCImproper installation procedure followed (Wrong A2/F1 configuration used).5Note in procedural manual.Not Applicable.10150Forward concern to customer. Distinct containers and labeling.MW 4/01/01.Forwarded on 3/12/01. ECR#23165 specifies package configuration. No further action.Provides reactant (bonding) Interface with F3.Adhesive Yield/FatigueHazard to end user.4CCPhysiochemical Instability (PI) (Cement Materials incompatability) (F3).2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability. Fluids Compatability test.216No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.4CCImproper installation procedure followed (Wrong F3 Mixture / content specified).5Note in procedural manual.Not Applicable.10200Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01. No further action.Easily installed.Not easily installed.Excessive installation time.2SCDimensional Incompatability (DI) (improper device configuration used).5Note in procedural manual. Maintainability Simulation.Not Applicable.10100Forward concern to customer. Distinct containers and labeling.MW 4/01/01.Forwarded on 3/12/01. ECR#23165 specifies package configuration. No further action.A3 : Pelvic Flange (lower) : Provide mounting and attachment interface to lower pelvic bone flange.Yield / Fatigue of attachment interfaceHazard to end user.4CCDimensional Incompatability (DI) (A3).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.216No further design action. SPC attachment configuration.MW 4/01/01.PCR#1 adds inspection requirements.4CCMaterials Incompatability (MI) (A3).2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability.12No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.4CCImproper installation procedure followed (Wrong configuration used).5Note in procedural manual.Not Applicable.10200Forward concern to customer. Distinct containers and labeling.MW 4/01/01.Forwarded on 3/12/01. ECR#23165 specifies package configuration. No further action.Positions/locates and retains F1 (6 places).DisplacedLoss of function. Extreme physical discomfort and customer dissatisfaction.3Dimensional Incompatability (DI) (A3 to F1).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.212No further design action. SPC attachment configuration.MW 4/01/01.PCR#1 adds inspection requirements.3Dimensional Incompatability (DI) (F1 to A3).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.212No further design action. SPC attachment configuration.MW 4/01/01.PCR#1 adds inspection requirements.3Materials Incompatability (MI) (A3/F1).2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability.212No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.Easily installed.Not easily installed.Excessive installation time.2SCImproper installation procedure followed (Wrong configuration used).5Note in procedural manual. Maintainability Simulation.Not Applicable.10100Forward concern to customer. Distinct containers and labeling.MW 4/01/01.Forwarded on 3/12/01. ECR#23165 specifies package configuration. No further action.Strength : Strength - Provides structural support.Yield/Fatigue.Hazard to end user.4CCMaterials Incompatability (MI) (A1/A2/A3/F1/F2/F3).Improper Materials specified.2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability.216No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.Size & Configuration : Adaptable to patient sizeNon adaptableLoss of function. Extreme physical discomfort and customer dissatisfaction.3Dimensional Incompatability (DI) (Improper configuration specified).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.212No further design action. SPC attachment configuration.Distinct containers and labeling.MW 4/01/01.PCR#1. ECR#23165 specifies package configuration. No further action.Finish (Coating) :HypoallergenicNon-HupoallergenicPotential Blood Poisoning.Hazard to end user.4CCImproper materials specified.2Mettalurgical lab analysis.Life Cycle Durability.216No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.Smooth surface :Provide bonding surface to A4 and F3Adhesive Yield/FatigueLoss of function. Extreme physical discomfort and customer dissatisfaction.3Improper surface finish specified.2Limit Stack Analysis (LSA). Cleanliness and Burr free note on detail drawing.Life Cycle Durability.212No further design action. 100% on line deburr operation.MW 4/01/01.PCR#1 adds inspection requirements.3SCImproper installation procedure followed (Contaminants introduced at interfaces).5Note in procedural manual.Not Applicable.10150Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01. No further action.Corrosion resistanceCorrosion.Potential Blood Poisoning.Hazard to end user.4CCImproper plating specified.2Mettalurgical lab analysis.Life Cycle Durability. Fluids Compatability test. 96 Hr. Salt Spray test.216No further design action. Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.Contaminant FreeContaminationPotential Blood Poisoning.Hazard to end user.4CCInadequate cleanliness provisions provided / specified.3Cleanliness and Burr free note on detail drawing.Not Applicable.336No further design action. Clean operation prior to hermetic pack.MW 4/01/01.ECR#98567 adds notes. PCR#2 adds clean operation.A4 : Polyethelyene Liner : Provides mounting interface to A2 and A5.Displaced.Loss of function. Extreme physical discomfort and customer dissatisfaction.3Dimensional Incompatability (DI) (Improper configuration specified).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.212No Action. Not Class responsible.Not Applicable.Not Applicable.3SCImproper installation procedure followed (Wrong configuration used).5Note in procedural manual.Not Applicable.10150Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01. No further action.Provides wear surface between A2 and A5.Excessive wearLoss of function. Extreme physical discomfort and customer dissatisfaction.3Improper materials specified.3Mettalurgical lab analysis.Life Cycle Durability. Fluids Compatability test.39No Action. Not Class responsible.Not Applicable.Not Applicable.Provides attachment interface to A2 .Yield/Fatigue of attachment interfaceLoss of function. Extreme physical discomfort and customer dissatisfaction.3Dimensional Incompatability (DI) (Improper configuration specified).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability. Fluids Compatability test.212No Action. Not Class responsible.Not Applicable.Not Applicable.Provides reactant (bonding) Interface with F3.Adhesive Yield/FatigueLoss of function. Extreme physical discomfort and customer dissatisfaction.3Physiochemical Instability (PI) (A3 to F3 Materials incompatability) .Incorrect Materials specified.3Mettalurgical lab analysis.Life Cycle Durability. Fluids Compatability test.39No further design action. A3 Material Lot Certifications.MW 4/01/01.SREA23 authorizes MLCs.Minimizes frictional wear at A2 to A5 interface.Excessive wearLoss of function. Extreme physical discomfort and customer dissatisfaction.3Incorrect Materials specified.3Mettalurgical lab analysis.Life Cycle Durability.39No Action. Not Class responsible.Not Applicable.Not Applicable.Hypoallergenic.Non-HupoallergenicPotential Blood Poisoning.Hazard to end user.4CCIncorrect Materials specified.2Mettalurgical lab analysis.Life Cycle Durability.216No Action. Not Class responsible.Not Applicable.Not Applicable.Easily installed.Not easily installed.Excessive installation time.2Dimensional Incompatability (DI) (Improper configuration specified).2Limit Stack Analysis (LSA). System Mockup. Maintainability Simulation.Life Cycle Durability.28No Action. Not Class responsible.Not Applicable.Not Applicable.2SCImproper installation procedure followed (Wrong configuration used).5Note in procedural manual.Not Applicable.10100Forward concern to customer. Distinct containers and labeling fpr A1/A2/A3.MW 4/01/01.Forwarded on 3/12/01. ECR#23165 specifies package configuration. No further action.A5 : Femoral Ball Replacement : Provides mounting interface (F5) to A2 and A4.Yield / Fatigue of attachment interfaceHazard to end user.4CCDimensional Incompatability (DI) (Improper configuration specified).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.216No Action. Not Class responsible.Not Applicable.Not Applicable.4CCImproper installation procedure followed (Wrong configuration used).5Note in procedural manual.Not Applicable.10200Forward concern to customer. Distinct containers and labeling fpr A1/A2/A3.MW 4/01/01.Forwarded on 3/12/01. ECR#23165 specifies package configuration. No further action.Corrosion resistanceCorrosion.Potential Blood Poisoning.Hazard to end user.4CCImproper plating specified.2Mettalurgical lab analysis.Life Cycle Durability. Fluids Compatability test. 96 Hr. Salt Spray test.216No Action. Not Class responsible.Not Applicable.Not Applicable.Provides mounting and attachment interface to femoral stem.Yield / Fatigue of attachment interfaceHazard to end user.4CCDimensional Incompatability (DI) (Improper configuration specified).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability. Fluids Compatability test.216No Action. Not Class responsible.Not Applicable.Not Applicable.4CCImproper installation procedure followed (Wrong configuration used).5Note in procedural manual.Not Applicable.10200Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01.Smooth finish.RoughExcessive wear at interface.Eventual loss of function. Extreme physical discomfort and customer dissatisfaction.3Improper surface finish specified.2Limit Stack Analysis (LSA). Cleanliness and Burr free note on detail drawing.Life Cycle Durability.212No Action. Not Class responsible.Not Applicable.Not Applicable.Load bearing.Yield / Fatigue of attachment interfaceHazard to end user.4CCIncorrect Materials specified.2Mettalurgical lab analysis.Life Cycle Durability. Fluids Compatability test.216No Action. Not Class responsible.Not Applicable.Not Applicable.Hypoallergenic.Non-HupoallergenicPotential Blood Poisoning.Hazard to end user.4CCIncorrect Materials specified.2Mettalurgical lab analysis.Life Cycle Durability. Fluids Compatability test.216No Action. Not Class responsible.Not Applicable.Not Applicable.Easily installed.Not easily installed.Excessive installation time.2Dimensional Incompatability (DI) (Improper configuration specified).2Limit Stack Analysis (LSA). System Mockup. Maintainability Simulation.Life Cycle Durability.28No Action. Not Class responsible.Not Applicable.Not Applicable.2SCImproper installation procedure followed (Wrong configuration used).5Note in procedural manual.Not Applicable.10100Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01.F1 / F2 : Threaded attachment : Provides mounting interface to A1,A2 and A3.DisplacedLoss of function. Extreme physical discomfort and customer dissatisfaction.3Dimensional Incompatability (DI) F1/F2 to A1/A2/A3(Improper configuration specified).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability.212No further design action. SPC attachment configuration For A1/A2/A3.MW 4/01/01.PCR#1 adds inspection requirements.Secures A1,A2,A3 to respective Pelvic bone joints.Yield / Fatigue of attachment interfaceHazard to end user.4CCMaterials Incompatability (MI) (F1/F2). Improper Materials specified.2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability.216No Action. Not Class responsible.Not Applicable.Not Applicable.Hypoallergenic.Non-HupoallergenicPotential Blood Poisoning.Hazard to end user.4CCIncorrect Materials specified.2Mettalurgical lab analysis.Life Cycle Durability.216No Action. Not Class responsible.Not Applicable.Not Applicable.Withstands corrosive influences.Corrosion.Potential Blood Poisoning.Hazard to end user.4CCIncorrect Materials specified.2Mettalurgical lab analysis.Life Cycle Durability. Fluids Compatability test. 96 Hr. Salt Spray test.216No Action. Not Class responsible.Not Applicable.Not Applicable.Smooth finish.Excessive wear at interface.Eventual loss of function. Extreme physical discomfort and customer dissatisfaction.3Improper surface finish specified.2Limit Stack Analysis (LSA). Cleanliness and Burr free note on detail drawing.Life Cycle Durability.212No Action. Not Class responsible.Not Applicable.Not Applicable.Load bearing.Yield/Fatigue.Hazard to end user.4CCMaterials Incompatability (MI) (F1/F2). Improper Materials specified.2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability. Fluids Compatability test.216No Action. Not Class responsible.Not Applicable.Not Applicable.Easily installed.Not easily installed.Excessive installation time.2Dimensional Incompatability (DI) F1/F2 to A1/A2/A3 (Improper F1/F2 configuration specified).2Limit Stack Analysis (LSA). System Mockup. Maintainability Simulation.Life Cycle Durability.28No further design action. SPC attachment configuration For A1/A2/A3.MW 4/01/01.PCR#1 adds inspection requirements.2SCImproper installation procedure followed (Wrong configuration used).5Note in procedural manual.Not Applicable.10100Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01.F3 : Cement : Secures A2 to femoral bone socket (2 places).Adhesive Yield/FatigueHazard to end user.4CCMaterials Incompatability (MI) (F3). Improper Materials specified.1Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability. Fluids Compatability test.4No further design action. Material Lot Certifications for A1/A2/A3.MW 4/01/01.SREA23 authorizes MLCs.4CCImproper content specified (F3).3Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability. Fluids Compatability test.336No Action. Not Class responsible.Not Applicable.4CCImproper installation procedure followed (Wrong cement used / Improper content).5Note in procedural manual.Not Applicable.10200Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01.4CCContamination at attachment interfaces.5Note in procedural manual.Not Applicable.10200Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01.Hypoallergenic.Non-HupoallergenicPotential Blood Poisoning.Hazard to end user.4CCIncorrect Materials specified.2Mettalurgical lab analysis.Life Cycle Durability.216No Action. Not Class responsible.Not Applicable.Not Applicable.Load bearing. Provides strength to femoral bone.Yield / FatigueHazard to end user.4CCMaterials Incompatability (MI) (F3). Improper Materials specified.2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability. Fluids Compatability test.216No Action. Not Class responsible.Not Applicable.Not Applicable.4CCImproper content specified (F3).2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability. Fluids Compatability test.216No Action. Not Class responsible.Not Applicable.Not Applicable.4CCImproper installation procedure followed (Wrong cement used / Improper content).5Note in procedural manual.Not Applicable.10200Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01.4CCContamination at attachment interfaces.5Note in procedural manual.Not Applicable.10200Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01.Withstands corrosive influences.Corrosion.Potential Blood Poisoning.Hazard to end user.4CCIncorrect Materials specified.2Mettalurgical lab analysis. Finite Element Analysis (FEA).Life Cycle Durability. Fluids Compatability test. 96 Hr. Salt Spray test.216No Action. Not Class responsible.Not Applicable.Not Applicable.Easily installed.Not easily installed.Excessive installation time.2Incorrect Materials specified.2Mettalurgical lab analysis. Finite Element Analysis (FEA). Maintainability Simulation.Life Cycle Durability.18No Action. Not Class responsible.Not Applicable.Not Applicable.F4 : Slip fit : Allows multi-axial loading , rotation between A2 and A5.Does not allow multi-axial loading , rotation.Loss of function. Extreme physical discomfort and customer dissatisfaction.3Dimensional Incompatability (DI) A1/A2/A3(Improper configuration specified).2Limit Stack Analysis (LSA). System Mockup.Life Cycle Durability. Fluids Compatability test.212No further design action. SPC attachment configuration. Distinct containers and labeling.MW 4/01/01.PCR#1 adds inspection requirements. ECR#23165 specifies package configuration. No further action.Easily installed.Not easily installed.Excessive installation time.2Dimensional Incompatability (DI) A1/A2/A3(Improper configuration specified).2Limit Stack Analysis (LSA). System Mockup. Maintainability Simulation.Life Cycle Durability.28No further design action. SPC attachment configuration. Distinct containers and labeling.MW 4/01/01.PCR#1 adds inspection requirements. ECR#23165 specifies package configuration. No further action.2SCImproper installation procedure followed (Wrong configuration used).5Note in procedural manual.Not Applicable.10100Forward concern to customer.MW 4/01/01.Forwarded on 3/12/01.SFMEA Statistics0