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Design Rationale
(ISTORY OF -ETAL
ON
-ETAL HOT ISOSTATIC PRESSING ( ()0) AND SOLUTION ANNEALING ( SA ) in
AN ATTEMPT TO IMPROVE HOMOGENEITY AND REDUCE POROSITY
%ARLY METAL
ON
METAL (MoM) DESIGNS OF THE S AND 3! WORKS TO HOMOGENIZE THE CHROMIUM AND MOLYBDENUM
S WERE ENCOURAGING IN TERMS OF STABILITY AND LOW WEAR RICH INTER
DENDRITIC REGIONS AND AS A RESULT MANY OF THE
BUT AS A WHOLE DID NOT MEET EXPECTATIONS DUE TO PRIMITIVE CARBIDES ARE DISSOLVED TO LEAVE A lNER CARBIDE DISTRIBUTION
MANUFACTURING AND IMPROPER CLEARANCE LEVELS 4HEREFORE #ARBIDES ARE VITAL FOR FATIGUE AND WEAR RESISTANCE !CCORDING
MOST METAL
ON
METAL DESIGNS FELL OUT OF FAVOR UNTIL THE MID to McMinn et al ()0 AND 3! POST PROCESSES MAY LEAD
S $URING THIS TIME "IOMET BEGAN DESIGNING NEW TO INCREASED METAL WEAR GENERATION DUE TO DEPLETION OF
BEARING TECHNOLOGIES WITH INNOVATIVE MATERIALS IMPROVED SURFACE CARBIDES5
MANUFACTURING CAPABILITIES AND OPTIMAL CLEARANCE
4HE -2A
-AGNUM™ SYSTEM FEATURES ARTICULATING SURFACES
MADE FROM HIGH CARBON #O#R-O ALLOY CARBON CONTENT
n PERCENT USING AN @AS
CAST MANUFACTURING PROCESS
3YSTEM $ESCRIPTION @!S
CAST REFERS TO THE METAL FORMING PROCESS WHERE
4HE -2A
-AGNUM™ ,ARGE -ETAL !RTICULATION 3YSTEM OFFERS MOLTEN METAL IS POURED INTO A MOLD COOLED AND SOLIDIlED
OPTIMAL JOINT MECHANIC RESTORATION AND ULTRA LOW
WEAR RATES TO TAKE ON THE lNAL SHAPE OF THE MOLD AND NO FURTHER
in vivo2 5NLIKE CERAMIC
ON
CERAMIC OR TRADITIONAL METAL
HEAT TREATMENT IS APPLIED "Y LEAVING THE METAL IN ITS
ON
POLYETHYLENE BEARINGS THE - 2A
-AGNUM ™ SYSTEM @AS
CAST FORM THE LARGER CARBIDES REMAIN INTACT &IGURE
OFFERS EXCELLENT STABILITY DISLOCATION RESISTANCE DECREASED !CCORDING TO #RAWLY et al @AS
CAST MATERIALS HAVE SHOWN
WEAR &IGURE AND A POTENTIAL MAXIMUM RANGE OF MOTION TO PROVIDE ENHANCED PROTECTION AGAINST ABRASIVE WEAR AND
EXCEEDING ª 4HIS IS ACHIEVED WITH A CONSTANT MM REDUCED OVERALL WEAR RATES COMPARED TO SINGLE OR MULTIPLE
MISMATCH BETWEEN THE HEAD AND CUP WHICH ALLOWS FOR HEAT TREATED MATERIALS
THE MAXIMUM HEAD SIZE TO BE INSERTED INTO THE SMALLEST
POSSIBLE CUP &OR EXAMPLE A HEAD SIZE AS LARGE AS MM
CAN BE INSERTED INTO A MM CUP
Material
-OST METAL
ON
METAL BEARING SYSTEMS FOR HIP REPLACEMENTS
ARE MANUFACTURED FROM #O#R-O ALLOY MATERIAL (OWEVER
THE PROCESS OF MANUFACTURING METAL
ON
METAL SYSTEMS Carbides Grain Boundary
VARIES !LTHOUGH MANY ORTHOPEDIC MANUFACTURERS USE
A CASTING PROCESS SOME APPLY POST
MANUFACTURING
Figure 2: The Biomet ‘as-cast’ material has a combination of fine
PROCESSES TO THEIR METAL
ON
METAL COMPONENTS KNOWN AS grain size for fatigue resistance and high carbide volume for wear
resistance.
#UP $ESIGN (EAD $ESIGN
4HE - A
-AGNUM CUP IS AN @AS
CAST HIGH CARBON COBALT
2 ™
4HE -2A
-AGNUM™ HEAD IS AN @AS
CAST HIGH CARBON
CHROME MOLYBDENUM #O#R-O ALLOY PRESS
lT DESIGN WITH #O#R-O ALLOY 4HIS IS ESSENTIAL TO MAINTAINING THE FATIGUE
A TITANIUM 003® 0OROUS 0LASMA 3PRAY OUTER SURFACE AND AND WEAR RESISTANCE CHARACTERISTICS OF THE -2A
-AGNUM™
A HIGHLY POLISHED INNER GEOMETRY 4HE EXTERIOR GEOMETRY ARTICULATION !LL -2A
-AGNUM™ HEADS ARE HONED AND
CONTAINS FOUR PAIRS OF PERIPHERAL lNS TO ENHANCE ROTATIONAL BUFFED TO ACHIEVE A STRICT SPHERICAL TOLERANCE OF «IN
STABILITY AND AID INITIAL lXATION &IGURE 4HE OUTER DIAMETER 4HIS SPHERICITY IS MEASURED USING MORE THAN
OF THE CUP IS FULLY HEMISPHERICAL ª WITH FOUR RIM INSPECTION POINTS ACROSS THE ENTIRETY OF THE ARTICULATING
INDENTATIONS FOR THE STABLE ATTACHMENT OF THE LOCKING SURFACE WITHIN A TEMPERATURE
CONTROLLED HUMIDITY AND
IMPACTION DEVICE 4HE INTERIOR GEOMETRY IS HONED AND VIBRATION
ISOLATED ENVIRONMENT
BUFFED TO A HIGH POLISH TO ACHIEVE A STRICT SPHERICAL TOLERANCE
OF «IN 7HEN THE APPROPRIATE -2A
-AGNUM™ HEAD AND
CUP ARE COMBINED THE HIGHLY POLISHED SURFACES ALLOW THE
HYDRODYNAMIC mUID lLM LAYER TO BUILD IN A MANNER OPTIMAL 4APERED )NSERT $ESIGN
FOR REDUCED WEAR (EAD SIZES AND MM ARE MONOBLOCK AND DO NOT USE
A MODULAR TAPER INSERT DUE TO THE SMALL DIAMETER &IGURE
(EAD SIZES MM AND LARGER USE A TITANIUM TAPERED INSERT
IDENTICAL IN ANGLE TO THE TRADITIONAL "IOMET® 4YPE TRUNNION
&IGURE 4HE TAPER INSERT OPTION IS ALSO AVAILABLE TO
ALLOW FOR OPERATIVE mEXIBILITY 4HESE INSERTS PROVIDE FOR SIX
NECK LENGTH OPTIONS TO RESTORE THE PROPER JOINT MECHANICS
FOR VARYING PATIENT ANATOMY
Figure 3
Figure 4
M 2a-Magnum Large Metal Articulation ™
Excessive Clearance
s (IGH CONTACT STRESSES 9,10
s 0OOR mUID lLM LUBRICATION DESIGN
s ,EADS TO INCREASED WEAR 9,10
Figure 10:
Optimal Clearance
s !LLOWS PROPER mUID LUBRICATION
Figure 7: Sphericity (roundness) and roughness are checked using s ,OW WEAR AND LOW FRICTIONAL TORQUE 9,10
non-contacting light interferometry through the use of Zygo PCI Laser. s 2OOM FOR REMOVAL OF WEAR DEBRIS
7EAR 4ESTING
7HEN TESTING THE RUN
IN WEAR OF HARD BEARINGS A BIPHASIC
PATTERN IS TYPICALLY SEEN WITH A HIGHER INITIAL @RUN
IN WEAR
RATE USUALLY LASTING n MILLION CYCLES FOLLOWED BY AN
EXTREMELY LOW LEVEL OF STEADY STATE WEAR THAT IS INVERSELY
PROPORTIONAL TO HEAD SIZE &IGURE
32mm .30 20
Volumetric Wear
38mm .12 15
46mm .18
10 Figure 12: Titanium PPS ® Porous Plasma Spray being applied
56mm .13 through a heated plasma arc.
5
28mm
27.9
ArCom®
0 4HE HEATING EFFECT OF THE 003® PROCESS IS TRANSIENT
Poly
97–98% less wear
ArCom®
Poly
28mm 32mm 38mm 46mm 56mm
LASTING ONLY FOR MILLISECONDS 4HEREFORE THE SUBSTRATE
Device
than ArCom® polyethylene
MATERIAL REMAINS VIRTUALLY UNAFFECTED FATIGUE PROPERTIES
ARE MAINTAINED SUCH THAT SMALL FEMORAL COMPONENTS ARE
Figure 11 POSSIBLE WITH THIS PROCESS AND IMPORTANTLY FOR -2A
-AGNUM™
ARTICULATION THE CARBIDE STRUCTURE IS UNAFFECTED
@2UN
IN WEAR OCCURS DURING THE TIME WHEN THE
COMPONENTS ARE BEDDING THEMSELVES IN AND EFFECTIVELY "IOMETS 003® COATING HAS IRREGULARLY SHAPED MOLTEN
POLISHING THEMSELVES INTO A CLOSELY CONFORMING CONTACT TITANIUM PARTICLES THAT SPLATTER UPON IMPACTION WITH THE
4HE DEGREE OF THIS WEAR IS DEPENDENT UPON RADIAL CLEARANCE SUBSTRATE SURFACE 4HIS GENERATES A RANDOM DISTRIBUTION
MATERIAL AND MANUFACTURING CAPABILITY SUCH AS CONTROL OF OF PORE SIZE BETWEEN AND MICRONS PROVIDING
SPHERICITY TOLERANCE AND SURFACE lNISH A LARGER CONTACT AREA BETWEEN PARTICLES AND SUBSTRATE
&IGURE 4HE LARGER DISTRIBUTION OF PORE SIZE IN CONJUNCTION
WITH THE ENHANCED BIOCOMPATIBILITY OF TITANIUM ALLOWS
IMMEDIATE lXATION VIA MECHANICAL INTERLOCKING AND LONG
0ROVEN &IXATION003 ® 0OROUS TERM lXATION THROUGH BONE IN
GROWTH
0LASMA 3PRAY #OATING
"IOMET WAS THE lRST ORTHOPEDIC COMPANY TO INTRODUCE A
PLASMA
SPRAYED PROSTHESIS WITH THE RELEASE OF THE 003®
COATED 4APERLOC® HIP STEM IN
)ON 2ELEASE
$ESPITE THE POSITIVE CLINICAL HISTORY OF THE -2A
-AGNUM™
ARTICULATION THERE HAVE BEEN CONCERNS REGARDING THE
LONG
TERM BIOLOGICAL CONSEQUENCES OF METAL
ON
METAL
WEAR DEBRIS PARTICULARLY THE RELEASE OF COBALT CHROMIUM
IONS INTO THE BODY )ON RELEASE IS NOT LIMITED TO METAL
ON
METAL HIPS -ETAL IONS ARE A NATURAL BY
PRODUCT OF VIRTUALLY
EVERY METALLIC IMPLANT AND MAY LEAD TO HIGHER THAN NORMAL
LEVELS OF COBALT AND CHROMIUM IN THE BLOODSTREAM .AILS
PLATES SCREWS AND EVEN TOTAL KNEES WILL RELEASE IONS OF
THEIR RESPECTIVE METALS25 -ANY STUDIES CONDUCTED OVER THE
LAST SEVERAL DECADES HAVE SHOWN NO DElNITIVE CORRELATION
OF NEGATIVE HEALTH ISSUES TO ION LEVELS EXHIBITED FROM
METAL
ON
METAL IMPLANTSn
140
Cancer Incidence
120
100
80 MoM
60 Expected
40
20
0
1
11
13
15
5
s PATIENTS
-IDTERM 2ESULTS OF s YEAR FOLLOW
UP
0OLYETHYLENE
&REE Journal of Arthroplasty
,OMBARDI ! et al s SURVIVORSHIP
-ETAL
ON
-ETAL n
Articulation s METAL LINERS AND POLY LINERS
s !LL COMPONENTS WELL
lXED AND STABLE
s n MM HEAD DIAMETERS AND VARIOUS
! (IP *OINT CLEARANCE LEVELS STUDIED
3IMULATOR 3TUDY OF s ,OW WEAR ACHIEVED WITH CAREFUL DESIGN
Journal of Arthroplasty
$OWSON $ et al THE 0ERFORMANCE OF AND PROPER mUID LUBRICATION
n
-ETAL
ON
-ETAL *OINTS s ,ARGE HEADS AND LOW DIAMETRICAL
0ART )) $ESIGN CLEARANCES ENSURE THAT JOINT WILL FUNCTION
WITH PROPER mUID lLM LUBRICATION
s 0OROUS 0LASMA 3PRAY 2ING,OC®
&IXATION AND /STEOLYSIS CUPS IMPLANTED
IN 0LASMA
3PRAYED
Journal of Arthroplasty s !VERAGE FOLLOW
UP YEARS
2EINA 2 et al (EMISPHERICAL #UPS
n s REVISION RATE FOR NON
CROSSLINKED
WITH (YBRID 4OTAL (IP
!RTHROPLASTY POLY WEAR
s #UPS REMAINED WELL
lXED
s ,ONG
TERM CLINICAL RESULTS OF -O- HIPS
s 2ETRIEVAL ANALYSIS INDICATED n MICRONS
4HE 2ATIONALE FOR Clinical Orthopaedics
OF WEAR PER YEAR AFTER INITIAL WEAR
IN
#UCKLER * -ETAL
ON
-ETAL 4OTAL and Related Research
COMPARED TO n MICRONS PER YEAR
(IP !RTHROPLASTY n
OF METAL
ON
POLYETHYLENE WEAR
s .O ADVERSE PHYSIOLOGIC EFFECTS
References
+IM 2 et al. -ETAL
ON
-ETAL 4OTAL (IP !RTHROPLASTY Journal of !LEXANDER * et al #HOICE OF )NGROWTH #OATING $RAMATICALLY !FFECTS
Arthroplasty THE 4ORSIONAL 3TABILITY OF #EMENTLESS &EMORAL 3TEMS 0OSTER EXHIBIT
TH !NNUAL /23 -EETING /RLANDO &, -ARCH
-C+ELLOP ( et al. )N 6IVO 7EAR OF 4HREE 4YPES OF -ETAL
ON
-ETAL
(IP 0ROSTHESES $URING 4WO $ECADES OF 5SE Clinical Orthopaedics "OURNE 2 et al )NGROWTH 3URFACES 0LASMA 3PRAY #OATING
and Related Research. n TO 4ITANIUM !LLOY (IP 2EPLACEMENTS Clinical Orthopaedics and
Related Research n
+OMISTEK 2 et al. )N 6IVO #OMPARISON OF (IP 3EPARATION !FTER
-ETAL
ON
-ETAL OR -ETAL
ON
0OLYETHYLENE 4OTAL (IP !RTHROPLASTY -EDING + et al. -INIMUM 4EN
9EAR &OLLOW
UP OF A 3TRAIGHT
Journal of Bone and Joint Surgery n 3TEMMED 0LASMA
3PRAYED 4ITANIUM
!LLOY 5NCEMENTED &EMORAL
#OMPONENT IN 0RIMARY 4OTAL (IP !RTHROPLASTY Journal of Bone and
(EAD 7 et al. -ECHANICAL 0ROPERTIES AND #LINICAL %VALUATION OF
Joint Surgery n
)SOSTATIC -OLDED !RCOM 0OLYETHYLENE International Society of
Orthopaedic Surgery and Traumatology 3AN $IEGO #! !UGUST -C,AUGHLIN * et al 4OTAL (IP !RTHROPLASTY WITH AN 5NCEMENTED
&EMORAL #OMPONENT %XCELLENT 2ESULTS AT 4EN 9EAR &OLLOW
5P
Journal of Bone and Joint Surgery " n
-C-INN $ et al. (IP 2ESURFACING 2ESURRECTED 0RESENTATION
%UROPEAN (IP 3OCIETY *UNE (OZACK 7 et al. 0RIMARY #EMENTLESS (IP !RTHROPLASTY WITH A
4ITANIUM 0LASMA 3PRAYED 0ROSTHESIS Clinical Orthopaedics and
#AWLEY * et al. 7EAR ! 4RIBOLOGICAL 3TUDY OF #OBALT #HROMIUM
Related Research.
-OLYBDENUM !LLOYS USED IN -ETAL
ON
-ETAL 2ESURFACING (IP
!RTHROPLASTY TH )NTERNATIONAL #ONFERENCE ON 7EAR OF -ATERIALS (EAD 7 et al. ! 4ITANIUM #EMENTLESS #ALCAR 2EPLACEMENT
n
&ALL 0ROSTHESIS IN 2EVISION 3URGERY OF THE &EMUR
9EAR %XPERIENCE
Journal of Arthroplasty n
$ATA ON lLE AT "IOMET "ENCH TEST RESULTS NOT NECESSARILY INDICATIVE
OF CLINICAL PERFORMANCE (EAD 7 et al. 4HE 0ROXIMAL 0OROUS #OATING !LTERNATIVE FOR 0RIMARY
!RTHROPLASTY Orthopedics n
3QUIRE - et al. !CETABULAR #OMPONENT $EFORMATION WITH 0RESS
&IT
&IXATION Journal of Arthroplasty. n -ARKEL $ et al )NITIAL 3CRATCH &IT 3TABILITY OF !CETABULAR #UPS
#OMPARISON OF 4HREE 0OROUS #OATING 3YSTEMS. International
$OWSON $ et al. ! (IP *OINT 3IMULATOR 3TUDY OF THE 0ERFORMANCE
Society of Orthopaedic Surgery and Traumatology n
OF -ETAL
ON
-ETAL *OINTS 0ART ) 4HE 2OLE OF -ATERIALS Journal of
Arthroplasty n
+ARAMAT , et al. "LOOD !NALYSIS FOR 4RACE -ETAL
ON
-ETAL AND
$OWSON $ et al. ! (IP *OINT 3IMULATOR 3TUDY OF THE 0ERFORMANCE
#ERAMIC
ON
#ERAMIC "EARINGS IN 4OTAL (IP !RTHROPLASTY !RTICLES OF
OF -ETAL
ON
-ETAL *OINTS 0ART )) 4HE 2OLE OF MATERIALS Journal of
)NTEREST -ETAL
ON
-ETAL !RTICULATION 7RIGHT -EDICAL -(
Arthroplasty n
3MITH 3 et al. 4HE %FFECT OF &EMORAL (EAD $IAMETER 5PON
4HARANI 2 et al. 4HE 2ISK OF #ANCER &OLLOWING 4OTAL (IP OR +NEE
,UBRICATION AND 7EAR OF -ETAL
ON
-ETAL 4OTAL (IP 2EPLACEMENTS
!RTHROPLASTY The Journal of Bone and Joint Surgery n
Proceedings of the Institute of Mechanical Engineers
n
6ISURI % et al. #ANCER 2ISK AFTER -ETAL ON -ETAL AND 0OLYETHYLENE
+EISU + et al. 0RIMARY #EMENTLESS 4OTAL (IP !RTHROPLASTY IN
ON -ETAL 4(! Clinical Orthopedics and Related Research
/CTOGENARIANS 4WO TO %LEVEN
9EAR &OLLOW
5P Journal of Bone and
n
Joint Surgery
3HAFFER !. et al )NCREASED "LOOD #OBALT AND #HROMIUM AFTER 4OTAL
-C,AUGHLIN * et al. 4OTAL (IP !RTHROPLASTY IN 9OUNG 0ATIENTS
TO
(IP 2EPLACEMENT Clinical Toxicology and Environmental Health
9EAR 2ESULTS 5SING AN 5NCEMENTED 3TEM Clinical Orthopaedics
n
and Related Research. n
"RODNER 7 et al. %LEVATED 3ERUM #OBALT WITH -ETAL ON -ETAL
0ARVIZI * et al. 0ROSPECTIVE -ATCHED
0AIR !NALYSIS OF (YDROXYAPATITE
!RTICULATING 3URFACES The Journal of Bone and Joint Surgery "
#OATED AND 5NCOATED &EMORAL 3TEMS IN 4OTAL (IP !RTHROPLASTY
n
Journal of Bone and Joint Surgery n
*ACOBS * et al #OBALT AND #HROMIUM #ONCENTRATIONS IN 0ATIENTS
-C,AUGHLIN * et al. 4OTAL (IP !RTHROPLASTY WITH AN 5NCEMENTED
WITH -ETAL ON -ETAL (IP 2EPLACEMENTS Clinical Orthopedics and
&EMORAL #OMPONENT ! ,ONG 4ERM 3TUDY OF THE 4APERLOC 3TEM.
Related Research n
Journal of Arthroplasty n
-AC$ONALD 3 et al. -ETAL ON -ETAL VERSUS -ETAL ON 0OLYETHYLENE
"OBYN *$ et al 4HE /PTIMAL 0ORE 3IZE FOR THE &IXATION OF
IN 4(! #LINICAL AND -ETAL )ON 2ESULTS OF A 0ROSPECTIVE 2ANDOMISED
0OROUS
SURFACED -ETAL )MPLANTS BY THE )NGROWTH OF "ONE Clinical #LINICAL 4RIAL The Journal of Bone and Joint Surgery. (British)
Orthopaedics and Related Research n
!LL TRADEMARKS HEREIN ARE THE PROPERTY OF "IOMET )NC OR ITS SUBSIDIARIES UNLESS
OTHERWISE INDICATED
4HIS MATERIAL IS INTENDED FOR THE SOLE USE AND BENElT OF THE "IOMET SALES FORCE AND
PHYSICIANS )T IS NOT TO BE REDISTRIBUTED DUPLICATED OR DISCLOSED WITHOUT THE EXPRESS
WRITTEN CONSENT OF "IOMET
ORTHOPEDICS
One Surgeon. One Patient.
SM