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SUMMARY OF SAFETY AND EFFECTIVENESS DATA

**I. [General Information]{.smallcaps}**

> Device generic name: Prosthesis, Hip, Semi-constrained,
> metal/ceramic/ceramic/metal, cemented or uncemented
>
> Device trade names: Howmedica Osteonics^®^ ABC System and
>
> Trident™ System
>
> Applicant's name and address: Howmedica Osteonics Corporation
>
> 359 Veterans Boulevard
>
> Rutherford, New Jersey 07070-2584
>
> PMA number: P000013
>
> Date of Panel recommendation: July 20, 2000
>
> Date of Notice of Approval to the Applicant: February 3, 2003

**II. [Indications for Use]{.smallcaps}**

The Howmedica Osteonics^®^ ABC System and Trident™ System are indicated
for patients requiring primary total hip arthroplasty due to painful
disabling joint disease of the hip resulting from non-inflammatory
degenerative arthritis (osteoarthritis, avascular necrosis, traumatic
arthritis, slipped capital epiphysis, pelvic fracture, femoral fracture,
failed fracture fixation or diastrophic variant).

#### **[Device Descriptions]{.smallcaps}**

> The Howmedica Osteonics^®^ ABC and Trident™ Systems are two
> ceramic-on-ceramic hip systems.
>
> **A.** The **Howmedica Osteonics^®^ ABC System** features a
> ceramic-on-ceramic acetabular bearing couple. The bearing couple
> consists of a Howmedica Osteonics^®^ Alumina C-Taper Head (ceramic
> femoral head) and a Howmedica Osteonics^®^ Alumina Insert (ceramic
> acetabular insert). Both components are manufactured out of alumina
> oxide ceramic manufactured by CeramTec of Germany.

1.  The ceramic femoral heads (28mm and 32mm) of the ABC System are
    intended to be used in conjunction with the commercially available
    press-fit titanium alloy Howmedica Osteonics^®^ Omnifit --HA Hip
    Stems.

2.  The ceramic acetabular inserts of the ABC System are intended to be
    used in conjunction with either of the commercially available
    Howmedica Osteonics^®^ PSL^®^ MicroStructured^®^ ABC Shells or the
    Howmedica Osteonics® Secur-Fit™-HA PSL^®^ ABC Shells (sizes 44mm to
    66mm in 2mm increments) in cementless applications. Additional
    fixation may be achieved with commercially available cancellous bone
    screws. Both shells are manufactured from commercially pure
    titanium. The PSL^®^ MicroStructured^®^ ABC Shell has a beaded
    porous coating whereas the Secur-Fit™-HA PSL^®^ ABC Shell features a
    non-porous hydroxyapatite coating. The ceramic inserts are assembled
    intraoperatively to the mating metal acetabular shell components via
    a taper locking mechanism.

> **B.** The **Trident™ System** features the same ceramic-on-ceramic
> acetabular bearing couple as the Howmedica Osteonics^®^ ABC System.
> However, the Trident™ Alumina Insert (ceramic acetabular insert)
> features a pre-assembled titanium alloy sleeve on the back of the
> insert which mates with the metal acetabular shell component via a
> taper locking mechanism. The insert is used in conjunction with the
> commercially available Trident™ AD with Pure-Fix HA Acetabular Shell
> in cementless applications. The Trident™ AD with Pure-Fix HA
> Acetabular Shell has the same non-porous hydroxyapatite coating as the
> Secur-Fit™-HA PSL^®^ ABC Shell. The bearing couple in the Trident™
> System consists of the same ceramic femoral heads as in the ABC
> System, as well as an additional 36mm head. The Trident System is also
> used in conjunction with the same press-fit Howmedica Osteonics^®^
> Omnifit --HA Hip Stems as the ABC System.

####### Contraindications, Warnings, and Precautions 

> **A. Contraindications**

-   Any active or suspected latent infection in or about the hip joint.

-   Any mental or neuromuscular disorder which would create an
    unacceptable risk of prosthesis instability, prosthesis fixation
    failure, or complications in postoperative care.

-   Bone stock compromised by disease, infection, or prior implantation,
    which cannot provide adequate support and/or fixation to the
    prosthesis.

-   Skeletal immaturity

> **B. Warnings**

-   Replace both the ceramic insert and the metal acetabular shell if
    the insert is chipped, cracked, or otherwise damaged during the
    implant procedure or postoperative timeframe. This is because the
    acetabular shell taper, once it has been deformed through assembly
    to its mating ceramic insert, cannot be reassembled to another
    ceramic insert.

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-   Always ensure proper alignment and seating of the insert before
    final impaction to prevent chipping or damage. Improper seating of
    the insert may cause it to bind in the wrong position, chip or be
    damaged.

-   Do not reassemble a ceramic head and metal femoral stem or a ceramic
    insert and metal acetabular shell once they have been assembled due
    to the deformation incurred by the taper locking mechanisms during
    the initial assembly.

-   Do not allow polished bearing areas and machined taper surfaces to
    come in contact with hard or abrasive surfaces, as scratching or in
    any way damaging these surfaces can significantly affect the
    structural integrity.

-   Do not substitute another manufacture's device for any of the
    Howmedica Osteonics^®^ ABC System because design, material, or
    tolerance differences may lead to premature device and/or functional
    failure. Components of the system have been specifically designed to
    work together.

-   Do not implant in obese patients because additional loading may lead
    to loss of fixation or device failure.

-   Do not implant in patients undergoing revision of previously
    unsuccessful femoral head replacement, cup arthroplasty, or other
    procedure because the safety and effectiveness of these devices for
    indications other than non-inflammatory degenerative joint disease
    have not been established**.**

-   Discard all damaged or mishandled implants. Never reuse an implant.
    Even though the implant appears undamaged, it may have small defects
    and internal stress patterns which may lead to early failure of the
    device.

-   **Do not resterilize.** Return all packages with flaws in the
    sterile barrier to the supplier.

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> **C. Precautions**

-   Clean bearing surfaces of debris prior to assembly as foreign
    particles may cause accelerated bearing wear, which may lead to
    early failure of the device.

-   Use caution when handling ceramic components during assembly because
    of the brittle nature of ceramic material.

-   Clean and dry machine taper surfaces to ensure proper seating and
    assembly.

-   Do not handle the hydroxylapatite treated regions as it may
    compromise the sterility or integrity of the coating/implant
    interface.

-   Do not contour or bend an implant because it may reduce its fatigue
    strength and cause failure under load.

-   Do not use a metal or zirconia head with the Howmedica Osteonics^®^
    Alumina Insert or the Trident™ Alumina Insert as this may accelerate
    bearing wear and lead to early failure of the device.

-   Ensure appropriate selection of bone screw length and location to
    avoid damage to underlying soft tissue structures. Perforation of
    the pelvic wall can result in internal bleeding and possible damage
    to vital organs.

-   Avoid excessive verticalization of the shell which may accelerate
    bearing wear.

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**V. [Alternate Practices and Procedures]{.smallcaps}**

Currently, the most commonly used implant materials for total hip
arthroplasty include metallic prostheses using articulating bearing
surfaces made of a combination of metallic and ultra-high molecular
weight polyethylene. Other alternatives use ceramic/polyethylene,
metal/metal and ceramic/ceramic bearing articulations. Total hip
prostheses are implanted by either cemented or cementless techniques.

> Depending on individual circumstances, alternate procedures include
> conservative, non-surgical treatment, hip joint fusion, or no
> treatment at all.

**VI. [Marketing History]{.smallcaps}**

The Howmedica Osteonics^®^ ABC System has been marketed internationally
since February 1997. These devices were distributed in the European
Union countries, Australia, Canada, China, Korea and Japan. The Trident™
System has been marketed internationally since September 1999. These
devices were distributed in the European Union countries, Australia and
Canada.

> No country has withdrawn the Howmedica Osteonics^®^ ABC Alumina Insert
> or the Trident™ Alumina Insert from the market for any safety or
> effectiveness related reason. These components were restricted to
> investigational use in the United States for clinical study.

**VII. [Potential Adverse Effects of the Device on Health]{.smallcaps}**

> Serious complications may be associated with any total hip joint
> replacement surgery. These complications include, but are not limited
> to: infection; genitourinary disorders; gastrointestinal disorders;
> vascular disorders, including thrombus; bronchopulmonary disorders,
> including emboli; myocardial infarction; temporary or permanent
> neuropathies; fractures of the femur; migration of the prosthesis;
> subluxation; dislocation; decreased range of motion; shortening or
> lengthening of the extremity; ectopic ossification; aggravated
> conditions in other joints or back due to intraoperative trauma, leg
> length discrepancy, or muscular deficiencies; metal sensitivity;
> possible detachment of the porous/HA coating which could lead to
> increased debris particles; excessive wear from damage to mating wear
> surfaces or debris particles; foreign body reaction; pain due to
> aseptic loosening; amputation; or death. While the expected life of
> total hip replacement components is difficult to estimate, it is
> finite. Component wear, breakage of the femoral head or acetabular
> insert, and component dissociation, are potential adverse effects
> related to ceramic/ceramic hip prostheses.

**VIII. [Summary of Preclinical Studies]{.smallcaps}**

The following nonclinical laboratory studies were performed in support
of the Howmedica Osteonics^®^ ABC and Trident™ Systems: microbiological,
materials, mechanical, and shelf life.

######## Microbiological Testing

1.  Bioburden and Sterility Testing

> Bioburden testing performed on Howmedica Osteonics^®^ Alumina C-Taper
> femoral heads, ABC Alumina Inserts and Trident™ Alumina Inserts
> provided results within stated process specifications. Sterilization
> validation according to AAMI 11137, Method 3, was performed on the
> Howmedica Osteonics^®^ Alumina C-Taper femoral heads (worst case) to
> demonstrate that a minimum gamma radiation sterilization dose of 25
> kGy provides a sterility assurance level (SAL) of 10^-6^. Bioburden
> data for the ABC Alumina Insert and Trident Alumina Insert were
> adequate to add these devices to the validated sterilization cycle.

2.  LAL and Cytotoxicity testing

> LAL and endotoxin testing was performed on Howmedica Osteonics^®^
> Alumina C-taper femoral heads. Testing showed the product is not
> cytotoxic in an extract assay. Testing revealed an endotoxin level of
> less than 0.125 eu/ml of endotoxin, which is an acceptable level. LAL
> and endotoxin testing for the Trident Alumina Inserts revealed an
> endotoxin level of less than 0.01eu/ml. Further biological testing was
> not performed on the ABC Alumina Inserts since this product is
> produced from the same material as the alumina C-taper femoral heads
> and Trident Alumina Inserts and has a similar geometry to the Trident
> Inserts.

######## Toxicological/Immunological/Biocompatibility

1.  Alumina Ceramics

Additional animal or clinical testing was not performed to confirm the
material's relative biocompatibility. This material has a long history
as an orthopedic implant material.

2.  Titanium Alloy

> Biocompatibility testing was performed on the titanium alloy (ASTM
> F-136) used to fabricate the titanium alloy sleeve for the Trident™
> Alumina Insert. The following extraction and implantation tests were
> performed:

-   In vitro cytotoxicity (MEM elution) in L-929 mouse fibroblast cell
    line

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-   In vitro hemolysis -- extracted in sodium chloride

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-   USP systemic toxicity in mice -- extracted in sodium chloride and
    cottonseed oil

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-   USP intracutaneous toxicity in rabbits -- extracted in sodium
    chloride and cottonseed oil

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-   USP pyrogen study in rabbits

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-   AMES mutagenicity study of a saline extract

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-   Delayed contact sensitization study in the guinea pig -- extracted
    in saline

In all tests performed, toxicity to the test articles was not observed.

In addition, titanium alloy discs were implanted intramuscularly in
rabbits. Macroscopic and microscopic tissue evaluations were performed
at 7 and 90 days. Results were considered to be within normal limits.

######## Mechanical/Wear Testing 

> A battery of tests was completed to qualify the mechanical performance
> of the components of the Howmedica Osteonics^®^ ABC and Trident™
> Systems. A summary of the tests performed and the results are given
> below.

1.  The following tests were performed on the ABC Alumina Inserts (and
    their mating alumina femoral heads and metal acetabular shells):

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(a) *[Compressive Burst Testing of ABC Alumina Inserts
    (liner)]{.underline}*

> Inserts were loaded to failure under axial compression using zirconia
> bearings as load application fixtures. The smallest of each inner
> diameter size (i.e., 28mm I.D./37mm O.D. and 32mm I.D./41mm O.D.) were
> chosen for testing as these represented the most severe cases of
> loading. The acetabular inserts exhibited average compressive burst
> loads greater than the specified 46.0 kN average minimum load
> requirement, and no insert fractured below the 20 kN minimum load
> specified for individual components. These loads are approximately 63
> and 27 times body weight (bw = 165 lbs), respectively.

(b) *[Axial Fatigue and Residual Burst Strength Testing of ABC Alumina
    Inserts]{.underline}*

> Five of the smallest sized inserts (i.e., 28mm I.D./37mm O.D. and 32mm
> I.D./41mm O.D.) were axially fatigue loaded under 14.0 kN (3150 lbs),
> R=0.1. Inserts were loaded with alumina heads and endured 10 million
> cycles. After fatigue testing each insert was subject to compressive
> burst testing to determine residual burst strength. No specimen
> fractured below the 20 kN minimum load. The average residual burst
> load for the 28 mm I.D x 37 mm O.D inserts was 63.6 kN, and the
> average for the 32 mm I.D x 41 mm O.D inserts was 66.5 kN. The alumina
> heads used for loading, which represented worst case head sizes, also
> successfully completed 10 million cycles and exhibited residual burst
> loads in excess of 20 kN.

(c) *[Axial Distraction of ABC Alumina Acetabular Inserts]{.underline}*

> Five of the smallest inserts were tested as this represented the worst
> case (ie., least contact area). The average axial distraction force of
> the 28 mm I.D / 37 mm O.D alumina insert was 2.752 kN. This compares
> favorably with published values for commercially available acetabular
> insert/shell assemblies ranging from approximately 0.224 kN to 2.937
> kN.

(d) *[Torsional Distraction of Alumina Inserts]{.underline}*

> Five of the smallest inserts were assembled with three mallet blows
> into CP Titanium taper models with interior taper surface/geometry
> specific to the devices under study. The average torsional distraction
> torque of the insert itself could not be accurately measured because
> failure occurred first at the torsion fixture interface. The average
> torsional distraction torque was not less than 448 in-lb., which
> represented the failure load of the torsional fixtures. The torque
> generated by friction at the bearing/insert interface has been shown
> to be on the order of 18 in-lb. The minimum torque demonstrated by the
> inserts substantially exceeded these published values.

(e) *[Three-Point Fixation Fatigue with Alumina Bearings (Heads and ABC
    Inserts)]{.underline}*

> The smallest diameter bearings of longer neck extensions were tested
> as this represented the most severe case. Five test articles were
> placed in fixtures and loaded under 4.89 kN (1100 lbs) max.,
> compressive fatigue load, R=0.1. All insert/head/hip stem constructs
> endured 10^7^ cycles without failure. After completion of the fatigue
> testing, the inserts were removed and examined for signs of wear, or
> fretting, at the insert/shell interface. Light circumferential CP Ti
> material transfer about the major diameter of the ceramic insert taper
> was seen. This is similar to that produced upon simple
> assembly/disassembly. Slight material transfer located about the minor
> diameter was believed attributable to a combination of off-axis
> loading and cyclic loading.

2.  Similarly, testing for the Trident™ Alumina Inserts included the
    following:

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(a) *[Static Burst Test for Trident Alumina Insert with Ti-alloy
    Sleeve]{.underline}*

> Static burst testing was performed on the 28mm and 32mm Trident
> Alumina Inserts. The average burst load for the 28mm Trident insert
> was 68.7 kN and the average burst load for the 32mm Trident insert was
> 70.2 kN. These values are above the specified minimum average axial
> burst load of 46 kN (with no single failure below 20 kN) . These
> failure loads are equivalent to approximately 95 times body weight.

(b) *[Post Axial Fatigue Burst Test for Trident Alumina Insert with
    Ti-alloy Sleeve]{.underline}*

> A similar static burst test was also performed on five 32mm Trident
> Alumina Inserts after 10 million cycles of fatigue loading. All
> samples tested in fatigue reached 10 million cycles run-out, at loads
> of up to 20 body weights (sinusoidal load of 315 to 3150 lbf \[14kN\]
> at 25 Hz) with no observable defects. The mean post-fatigue burst load
> for the 32mm Trident Alumina Insert was 70.1 kN.

(c) *[Fatigue Testing of the Trident Acetabular Cup System]{.underline}*

> Additional fatigue testing of the Trident Alumina Insert assembled to
> the Trident Acetabular Shell was performed. Testing simulated relevant
> physiological loading. Loads applied were based on gait studies in the
> literature, where expected loads ranged from 672 lbs during normal
> activities to maximum loads of 1148 lbs. A cyclic axial compressive
> force was applied at a rate of 10 Hz. No failures occurred at load
> levels up to 1500 lbs. One specimen tested at 1600 lbs completed 10
> million cycles but post-fatigue testing revealed failure in the
> ceramic liner. This result exceeds the expected physiological load
> levels as observed in the literature.
>
> *(d)* *[Axial Push In/Out and Fretting Test for Trident Alumina Insert
> with Ti-alloy Sleeve]{.underline}* The static locking strength of the
> shell-insert/sleeve construct was tested through an axial push-out
> test. The axial push-out load for the Trident Alumina Insert (with
> Ti-alloy sleeve), with an average 2 kN (450 lbf) impaction force, was
> 1.1 kN (248 lbf.). This compares favorably with published data.
>
> The taper surfaces of the titanium alloy sleeve and shell were
> inspected qualitatively for the severity of fretting wear due to
> fatigue loading of the shell-insert/sleeve construct. All shells,
> inserts, sleeves, and femoral heads successfully endured 10 million
> cycles of fatigue loading without structural compromise. The degree of
> fretting was milder than that seen with the current ABC acetabular
> shell and alumina insert design.
>
> *[(e) Mechanical Evaluation of 36mm Trident Ceramic/Ceramic
> Liners]{.underline}*
>
> Both axial distraction (or push-out) and ultimate axial compression
> load (burst) testing were performed. Five samples were evaluated for
> each test. Average distraction force was 653 57 N (147 lbf). The
> acetabular inserts exhibited an average compressive burst load of 55.0
> 9.2 kN (12360 lbf) and no insert failed below 46.4 kN (10427 lbf). The
> loads are approximately 75 and 63 times body weight, respectively. The
> values reported here are within the range of values reported for other
> similar devices. Burst testing on the 36 mm alumina femoral heads
> demonstrated average failure loads of 91.8 kN for the +3.5 heads and
> greater than 71.3 kN for the +5 heads. It should be noted that a
> single 36 mm alumina ceramic head was used in the burst testing for
> all the ceramic acetabular inserts. In every case the inserts
> fractured first, indicating that the 36 mm femoral heads are
> appropriate for use with the ceramic inserts.

3.  Joint simulation wear performance testing of the Biolox^®^ Forte
    alumina-alumina bearing couple has been characterized throughout a
    range of severe conditions, including steep cup inclination angles,
    head-insert micro-separation, increased swing phase loading, and
    alternative lubricating media. The following wear tests have been
    performed:

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(a) *In-vitro Wear Performance of the Biolox*^®^ *Forte Alumina/Alumina
    Bearing Couple Under Hip Joint Simulation -- Gravimetric Results*

> This joint simulation study investigated the Biolox^®^ Forte couple in
> an anatomic (superior) cup insert orientation and demonstrated a 400X
> decrease in mass and 2000X decrease in volumetric wear compared to
> UHMWPE inserts at 5 million cycles. The level of wear reduction and
> the wear surface features were consistent with those reported and
> observed clinically from device retrievals. Although the cup was
> positioned above the femoral bearing, the level of inclination was 0
> degrees; hence, this model is not considered to be overly severe.

(b) *Wear of [HIP'd (hot isostatic pressed)]{.underline} and Non-HIP'd
    Alumina/Alumina Hip Joints under Standard and Harsh Simulator
    Conditions*

> Previous generation non-HIP'd alumina and the contemporary HIP'd
> material grade alumina were compared under standard and "harsh"
> testing conditions. The severe conditions were created by elevating
> the swing phase load (intended to deplete the lubricating film at the
> articulating interface) and by varying the lipid and protein
> concentration of the lubricating media. None of these test conditions
> were able to induce accelerated wear of the HIP'd alumina components
> (Biolox Forte). Inserts were mounted at a relatively severe 60 degrees
> of inclination.

(c) *Micro-Separation of the Centers of Alumina/Alumina Hip Joints
    During Simulator Testing that Produces Clinically Relevant Wear
    Rates and Patterns*

> Upon incorporating a cyclic micro-separation of the head from the
> insert during joint simulation a 15-fold increase in the early wear
> rate of the alumina/alumina bearing couples was reported, as compared
> to results in the same simulator under standard testing conditions for
> a similar period. These results appear to be consistent with wear
> rates of retrieved alumina/alumina bearings, as reported in the
> literature. Inserts were oriented at 60 degrees of inclination.
> Micro-separation that occurs during the swing phase of normal walking
> may be considered a severe condition since it serves as an indicator
> of joint laxity.

(d) *Influence of Acetabular Cup Angle on the Wear of Biolox Forte
    Alumina/Alumina Hip Joints in a Physiological Simulator*

> This study increased the inclination angle of alumina inserts from 45
> to 60 degrees after 2 million cycles of hip joint simulation. There
> was no increase in wear rate associated with the greater inclination
> throughout an additional 2 million cycles. The increase in cup
> inclination may simulate the onset of cup migration/loss of fixation
> leading to a more vertical shell. These are scenarios that also
> represent non-ideal clinical conditions.

(e) *The Effect of Inclination Angle on In-Vitro Wear of Alumina/Alumina
    Acetabular Inserts*

> Alumina insert/bearing pairs were tested at 50, 55, 60, and 65 degrees
> of inclination under standard hip joint simulation parameters. The
> inserts were positioned anatomically with respect to the bearings
> (i.e., cup on top). Components tested at 50, 55, and 60 degrees
> exhibited nearly identical wear rates, while specimens inclined at 65
> degrees exhibited a 4X increase in wear rate with respect to the lower
> inclination angles evaluated.

## **D. Fretting Fatigue and Corrosion Testing of the Trident™ Acetabular Cup System**

> High cycle fatigue testing of the Trident™ Acetabular System with the
> alumina insert has been performed. Testing consisted of high
> cycle/short term testing (10 million cycles / 10 Hz (12 days)) at
> loads of approximately 3 times body weight to evaluate fretting, and
> high cycle/long term testing (10 million cycles / 1 Hz (120 days)) to
> evaluate corrosion at the metal/metal taper junction due to
> physiologically relevant load conditions. Acetabular shells were
> oriented at 45 degrees inclination. Both macro and microscopic
> inspection of the acetabular components showed minimal damage due to
> fretting and no evidence of corrosion at the metal/metal interface.
> Fretting testing was also performed on two femoral components so that
> comparisons could be made to modular connections that have been used
> in the clinical setting. Qualitatively, slightly more damage was seen
> on the femoral stem tapers than the taper lock between the acetabular
> shell and liner of the Trident™ components. These results indicate a
> stable interface exists between the liner and shell for up to ten
> million cycles.
>
> **E. Surface Characterization of the Alumina-Alumina Bearing Couple**
>
> The Alumina C-Taper Heads and Alumina Inserts were evaluated using 3-D
> laser inteferometery. Contour maps and photomicrographs under SEM at
> 1000X magnification were produced. The overall average roughness,
> R~A~, of the alumina femoral bearing surface was 1.85 x 10^-3^um. The
> level of finish produced on the polished acetabular insert surface
> averaged 4.32 x 10^-3^um.

######## F. Finite Element Modeling

> Finite Element Modeling was performed to evaluate stress at the
> metallic shell/bone interface in order to determine the differences in
> bone stresses when comparing the ABC and Trident™ designs. The
> Trident™ shell design is slightly thinner than the ABC design. The
> maximum observed difference in bone stress between the two shell
> geometries was 5%, with Trident™ producing slightly less stress at the
> bone interface than the ABC, approximately 1720 psi to 1810 psi,
> respectively.

######## 

######## G. Shelf Life Testing 

> Shelf life testing was performed to verify sterile packaging integrity
> equivalent to five years. This testing was performed on acetabular
> cups, inserts and femoral stems. Qualification of the blister package
> assembly for the Alumina Inserts was also performed.

####### Summary of clinical studies 

There were three groups evaluated in the IDE. The first group consisted
of a prospective, randomized, multi-centered, concurrently controlled
study of the Howmedica Osteonics^®^ ABC System. The second group
consisted of the Continued Access cases receiving the ABC System, which
was a prospective, non-randomized, non-controlled, multi-centered study.
The third group consisted of those cases receiving the Trident™ System,
which was a prospective, non-randomized, historically controlled,
multi-centered study.

Clinical data had been collected on a total of 820 cases at the time of
database closure. Of these cases, 515 belonged to the first group. That
is, 350 cases received the ABC System (173 ABC System I and 177 ABC
System II) and 165 received the control (Control System). ABC System I
devices consisted of the Howmedica Osteonics^®^ Alumina C-Taper Heads,
Howmedica Osteonics^®^ Omnifit --HA Hip Stems, Howmedica Osteonics^®^
Alumina Inserts, and the Howmedica Osteonics^®^ PSL MicroStructured ABC
Shells. The ABC System II devices consisted of the identical components
except for the use of a different acetabular shell, the Howmedica
Osteonics^®^ Secur-Fit --HA PSL ABC Shell. The Control System devices
consisted of the commercially available Howmedica Osteonics^®^ Omnifit
Series II Polyethylene Cup Inserts and Howmedica Osteonics^®^ C-Taper
CoCr Heads used in combination with the Howmedica Osteonics^®^ Omnifit
PSL MicroStructured Acetabular Shell and the Howmedica Osteonics^®^
Omnifit --HA Hip Stems. Group two consisted of 116 cases receiving the
ABC System (3 ABC System I, 113 ABC System II) via continued access. The
remaining 189 cases (group three) were implanted with the Trident™
System. The Trident™ System features the same ceramic-on-ceramic
acetabular bearing couple as the Howmedica Osteonics^®^ ABC System. The
Trident™ Alumina Insert features a pre-assembled titanium alloy sleeve.
The insert is used with a Trident™ AD with Pure-Fix HA Acetabular Shell
in cementless applications. The bearing couple in the Trident™ System
consists of the same Howmedica Osteonics^®^ Alumina C-Taper Heads as in
the Howmedica Osteonics^®^ ABC System, as well as an additional 36mm
head. The Trident System can also be used with the same press-fit
Howmedica Osteonics^®^ Omnifit --HA Hip Stems as the ABC System.

All components in all three groups were implanted without cement. The
--HA designated components contain an hydroxyapatite coating. Please
refer to Table 1 for a time-course patient accountability of all three
groups.

Four hundred and thirteen randomized cases from the first group had at
least 2 year follow-up data (i.e., 140 ABC I, 140 ABC II, 133 Control).
That data was used in the statistical analysis for the Howmedica
Osteonics^®^ ABC System, and is presented in section A, below. The data
from the remaining 102 randomized cases with less than 2 years of
follow-up, and the 116 Continued Access cases was used to provide
additional safety information for the Howmedica Osteonics^®^ ABC System.
Section B, below, provides information from the Continued Access Study
group. Section C provides data from the Trident™ Study group.

######## A. The Howmedica Osteonics® ABC System 

> 1\. Study Design
>
> The Howmedica Osteonics^®^ ABC System study was a prospective,
> controlled, randomized, multi-center clinical trial. The total study
> group consisted of 514 cases diagnosed with non-inflammatory
> degenerative joint disease (NIDJD) requiring a primary total hip
> replacement. One additional non-randomized case with a diagnosis of
> inflammatory arthritis was implanted with Howmedica Osteonics^®^ ABC
> System I as a compassionate use approved deviation from protocol and
> is analyzed separately for safety in the data analysis. Each subject
> was randomized to receive one of three possible shell/bearing
> combinations: either the Howmedica Osteonics^®^ ABC System I, the
> Howmedica Osteonics^®^ ABC System II (the Investigational Systems), or
> the Control System in a cementless application. Two year results for
> 280 Investigational cases (140 ABC I and 140 ABC II) and 133 Control
> cases were included in the data and will be presented in this section.

2.  Patient Assessments

Preoperative functional (Harris Hip Score), demographic and Patient
Satisfaction (HSQ-12; Hip Society) data as well as AP and ML radiographs
were obtained. A Surgical Details case report form was completed to
record relevant surgical information. Postoperatively, patients were
evaluated at 7 weeks, 6 months, 12 months and 24 months. Subjects will
be evaluated annually thereafter until the last patient entered into the
study has completed a minimum of two years follow-up. AP and ML
radiographs were reviewed by an independent reviewer (orthopedic
surgeon). A patient satisfaction questionnaire was given at all
follow-up intervals except the 7 week interval.

3.  Patient Success/Failure Criteria

All of the following criteria needed to be met for a patient to be
considered a success in the Howmedica Osteonics^®^ ABC study:

-   Absence of surgical revision/removal of any of the total hip system
    components;

-   Harris Hip Score of 70 or greater;

-   Progressive radiolucent lines less than 2mm in thickness around the
    acetabular component;

-   Migration of the acetabular component of less than 3mm;

-   Progressive radiolucent lines of less than 2 mm in thickness
    surrounding the femoral component; and,

-   Progressive subsidence of the femoral component of less than 5mm.

A patient was defined as a failure if they did not meet all of the above
success criteria.

4.  Study Success/Failure Criteria

> Study success required meeting both of the following criteria:

-   Not detecting as statistically significant an increase 7.5% in the 2
    year patient failure rate for the treatment group compared to the 2
    year failure rate for the control group; and,

-   Complication rates that are statistically no worse than the control.

5.  Subject Selection

Subjects were recruited through medical institutions of the
participating investigators and have been diagnosed with
non-inflammatory degenerative joint disease (NIDJD). Both male and
female subjects between the ages of 21 and 75 years inclusive, were
selected to participate.

6.  Demographic Data

a\. [Investigational Group demographics]{.underline}: There were more
males (186 cases; 66.4%) than females (94 cases; 33.6%); the mean age of
study cases was 53.4 years with the mean age of female cases reported as
53.3 years (range 21 to 75 years) and the mean age of male cases
reported as 53.4 years (range 23 to 73 years). The primary diagnosis for
these cases included 225 cases (80.4%) with osteoarthritis, 10 cases
(3.6%) with traumatic arthritis, 41 cases (14.6%) with avascular
necrosis, 3 cases (1.1%) with diastrophic variant, and 1 case (0.4%)
with slipped capital epiphysis.

> b\. [Control Group demographics]{.underline}: There were more males
> (83 cases; 62.4%) than females (50 cases; 37.6%); the mean age of
> study cases was 54.5 years with the mean age of female cases reported
> as 56.1 years (range 28 to 74 years) and the mean age of male cases
> reported as 53.6 years (range 25 to 75 years).
>
> The Investigational and Control groups had comparable demographics in
> terms of gender, age, height, weight, and primary diagnoses.

7.  Data Analysis and Results

> Two hundred eighty investigational cases (140 ABC System I, 140 ABC
> System II) and 133 Control cases were included in the data analysis.
> This population reports a study follow-up rate of 92.7%, with the
> Investigational and Control groups having similar follow-up rates.

a.  Study Efficacy Results

> The effectiveness of the Howmedica Osteonics^®^ ABC System I and ABC
> System II was determined through the analysis of the Harris Hip Scores
> and radiographic measurements. Table 2 compares the Mean Total Harris
> Hip Scores and the Harris Hip Rating Scale, as well as the
> radiographic success rates for the Investigational and Control groups,
> at two years postoperatively. The mean total HHS and the HHS
> Good/Excellent Rating were similar for the Investigational and Control
> groups for all parameters that were evaluated.
>
> Radiographic parameters of femoral radiolucency, femoral component
> subsidence, acetabular radiolucency, acetabular component migration,
> and excessive wear as demonstrated by migration of the femoral head in
> the insert were used to assess the stability of the study components.
> Only one of the 245 Investigational cases (0.4%)with two year
> radiographic data was determined to be a radiographic failure. This
> patient received the ABC System II and displayed a progressive
> subsidence of the femoral component greater than 5mm, which was
> considered a radiographic failure as defined by the study protocol.
> The radiographic results for the Investigational and Control groups
> were very similar for all parameters evaluated.
>
> b\. Study Safety Results
>
> The primary safety variables used to measure the success of the
> Howmedica Osteonics^®^ ABC System are intraoperative and postoperative
> complications/adverse events and component removal events.
> Complications, whether device-related or not, were recorded and
> reported for both the Investigational and Control groups. Table 3
> provides a time course distribution for all reported operative site
> related adverse events. Table 4 provides a time course distribution
> for all reported systemic adverse events. Included within these tables
> are the adverse events reported for those cases who have not yet
> reached two year postoperative follow-up. Safety data from the
> Continued Access patient group are also included in these tables.
>
> The three revisions reported in the Investigational device group were
> due to postoperative femoral fracture (ABC System I), recurrent
> anterior dislocation (ABC System II), and deep joint infection (ABC
> System II). The femoral fracture required the removal and revision of
> the femoral head and stem components. The dislocation case required
> removal and revision of the acetabular shell and insert, as well as
> the femoral head. The deep joint infection required the removal and
> revision of all four components (acetabular shell and insert, femoral
> head and stem). The five revisions identified in the control group
> were due to a femoral fracture related to a traumatic event, painful
> leg length discrepancy, deep joint infection, recurrent dislocation,
> and dislocation that could not be reduced by closed reduction. There
> was no evidence of any differences in adverse event rates between the
> various study groups. Adverse event rates were similar for both
> Investigational groups and the Control group.

c.  Study Success

> Table 5 summarizes the 2 year patient success rates as they relate to
> the success/failure criteria of the Howmedica Osteonics^®^ ABC Study.
> For the purposes of the study, a patient who failed to meet all seven
> of the success criteria outlined in the table was considered a
> failure. Success for the ABC System Study was defined, in part, by
> demonstrating patient success rates for ABC System I and ABC System II
> that were no more than 7.5 percentage points worse than the Control
> System patient success rate. In addition, success was based on
> achieving complication rates that were statistically no worse than the
> Control System.
>
> Both ABC System I and ABC System II demonstrated slightly higher
> patient success rates than the Control System at two years
> postoperatively. As previously discussed, adverse event rates were
> found to be similar for both ABC and Control Systems. The results of
> the study demonstrate that the use of the ABC System I and System II
> devices can, at least two years after implantation, produce clinical
> results comparable to the Control System.

##### B. Continued Access Cases

#####  The Continued Access portion of the Howmedica Osteonics^®^ ABC System study allowed surgeons to continue use and study the ABC System I and System II investigational devices in a non-randomized manner. Each of these systems was used in combination with the commercially available Howmedica Osteonics^®^ Omnifit --HA Hip stem. A maximum of 336 cases were allowed to be enrolled in the Continued Access study arm. No statistical analysis was performed for this study group. Data from this study arm was used for safety and effectiveness comparison purposes only. The clinical protocol for this arm of the investigation was identical to the protocol for the original cohort with the following exceptions:

-   Study is non-randomized

-   Surgeons involved in this arm were allowed to choose either ABC
    System I or System II components

-   The Twelve Item Health Questionaires (HSQ-12) were not collected

-   Postoperatively, data were collected at 7 week and 1 year follow-up
    intervals and biannually thereafter until all patients in the
    original cohort reach two year follow-up. Functional evaluation and
    x-rays were taken at these time periods. The clinical protocol for
    the original cohort also included a follow-up at six months.

##### 

> Subjects in this prospective, non-randomized study arm received either
> the Howmedica Osteonics^®^ ABC System I or System II at the discretion
> of the operating surgeon. To date, 116 cases have been enrolled. Three
> cases received System I; 113 cases received System II. The data was
> pooled for data analysis. Two cases were removed from the analysis, as
> one compassionate use patient did not meet the inclusion criteria and
> in one case the decision was made intraoperatively not to use the
> investigational alumina insert.
>
> Data on 114 cases was presented for this device group. There were more
> males (80 cases; 70%) than females (34 cases; 30%). The mean age of
> study cases was 48.2 years with the mean age of females reported as
> 47.7 years (range 24 to 66 years) and the mean age of male cases
> reported as 48.4 years (range 24 to 73 years). The primary diagnosis
> for these cases included 83 cases (73.0 %) with osteoarthritis, 8
> cases (7.0%) with traumatic arthritis, 18 cases (15.8%) with avascular
> necrosis, 2 cases (1.8%) with slipped capital epiphysis, and one case
> (0.9 %) with congenital hip dysplasia. Seven patients were reported to
> be bilaterally implanted.
>
> The average length of follow-up for these cases is 260.9 days (range
> 27 -- 420 days). One hundred thirteen of one hundred fourteen expected
> cases (99.1%) had seven week evaluation data reported and 77 of 86
> expected cases (89.5%) had one year evaluation data reported. At 7
> weeks postoperatively the mean Harris Hip Score was 80.9 points (range
> 42.7 to 100). At one year postoperatively the mean Harris Hip Score
> was 96.8 points (range 54.9 to 100). No radiographic review was
> available for this group at the time of data base closure.
>
> There were no deaths or revisions reported for this study population.
> There were six reports of intraoperative chipping of the ceramic
> acetabular inserts in this group. These cases were reported to have no
> untoward results due to the intraoperative chipping. There was one
> reported case of intraoperative femoral fracture and three reported
> cases with intraoperative femoral cracks. One case of dislocation was
> reported. Time course distributions of adverse events (operative site
> related and systemic) were provided for this study group and are
> included in Tables 3 and 4, respectively.

##### C. Trident™ Study Arm

> This study design is a prospective, non-randomized historically
> controlled, multicenter clinical trial. The total study group will
> consist of 213 cases diagnosed with NIDJD. The Trident™ System data
> were compared to the ABC I, ABC II, and control group data collected
> in the ABC System study. Patient enrollment began on 9/20/99. To date,
> 189 cases have been enrolled, 4 of which did not meet the study
> inclusion criteria and are not included in the study analysis.
>
> The Trident™ study protocol is identical to the original ABC protocol,
> with the exception of using the historical control (ABC control
> device) instead of incorporating a randomized control. There were more
> males (125 cases; 67.6%) than females (60 cases; 32.4%); the mean age
> of study cases was 51.8 years with the mean age of female cases
> reported as 52.0 years (range 31 to 74 years) and the mean age of male
> cases reported as 51.8 years (range 31 to 74 years). The primary
> diagnosis for these cases included 150 cases (81.1%) with
> osteoarthritis, 7 cases (3.8%) with traumatic arthritis, 20 cases
> (10.8%) with avascular necrosis, 7 cases (3.8%) with slipped capital
> epiphysis, and 1 case (0.5%) with a femoral fracture. Preoperatively,
> the Trident™ data were comparable with the ABC I, ABC II, and Control
> systems of the ABC study.
>
> The average length of follow-up for these cases is 120.2 days (range
> 29 -- 262 days). One hundred seventy-eight of the 182 cases expected
> (97.8%) had a seven week evaluation and 97 of the 103 cases expected
> (94.2%) had a 6 month evaluation. There have been no reports of
> intraoperative chipping of the Trident™ Alumina Insert and there has
> been one femoral component revision reported due to a femoral
> fracture. No deaths have been reported. There are two cases with
> Harris Hip Scores \< 70 reported at 6 months. No radiographic review
> was available for this group at time of data base closure.
>
> No statistical differences were found in the comparisons of the
> preoperative, 7 week and 6 month mean Harris Hip Scores between the
> Trident™ cohort and the other cohorts. A time course distribution that
> compares the early effectiveness data (Harris Hip Scores) of the
> Trident™ System to the ABC System I, ABC System II, and Control System
> is provided in Table 6.
>
> A comparison of the adverse event rates for the Trident™ System, ABC
> System I, ABC System II, and Control System was performed for the
> purposes of evaluating safety. There was one statistically significant
> finding made involving the intraoperative operative site event rates.
> There was a significantly higher rate for the ABC Systems compared to
> the Trident™ System, but not for the Control System versus the
> Trident™ System. This difference was due to the intraoperative
> chipping of a few of the ABC inserts. Other than this one exception,
> the adverse event rates for the Trident™ study arm were generally not
> significantly different from the other study groups. Time course
> distributions of adverse events (operative site related and systemic)
> were provided for this study group and are included in Tables 7 and 8,
> respectively.

**X. [Conclusions drawn from the studies]{.smallcaps}**

######## A. Risk/Benefit Analysis

> Other than the risks generally associated with total hip arthroplasty
> the following additional risks were identified for the Howmedica
> Osteonics^®^ ABC System and Trident™ System components: breakage of
> the ceramic insert or femoral head, the necessity for removal of all
> ceramic components if one must be removed/revised (ABC System only),
> corrosion between the metal acetabular shell and the metal sleeve of
> the acetabular insert (Trident™ System only) and intraoperative
> chipping of the ceramic insert. Including those cases with less than 2
> years follow-up and the continued access cases, there were 16
> incidences of chipping for the 466 cases implanted with the ABC
> alumina insert (3.4%). To date there have been no untoward events
> reported as a result of any of the chipping cases. In all instances
> the chipped inserts were replaced at time of surgery with no
> subsequent clinical sequelae. The clinical outcomes of those patients
> with chipped inserts were comparable to those patients without chipped
> inserts. This chipping problem has not been seen with the Trident™
> Insert.
>
> It is reasonable to conclude that the benefits of the use of the ABC
> System and Trident™ System for the intended target population outweigh
> the risk of injury when used in accordance with the directions for
> use.

######## B. Safety and Effectiveness

> The effectiveness of the Howmedica Osteonics^®^ ABC System was
> demonstrated through the compilation of data exhibiting the relief of
> pain and return to normal function which was collected during the
> course of this prospective, randomized, controlled clinical trial. The
> safety of the Howmedica Osteonics^®^ ABC System was established
> through the collection of complications/adverse events and component
> removal events. The overall failure rates for the Howmedica
> Osteonics^®^ ABC System compared favorably to the Control System.
>
> The modification to the Howmedica Osteonics^®^ ABC Insert, which is
> incorporated into the Trident™ design, involves the locking mechanism
> between the insert and the shell. The safety of the Trident™ Alumina
> Insert has been established through the evaluation of the
> perioperative adverse event rates. There was one statistically
> significant finding made in the safety analysis comparing the Trident™
> and Howmedica Osteonics^®^ ABC Systems. The intraoperative operative
> site event rate was significantly higher for the ABC Systems compared
> to the Trident™ System. This difference can be attributed to the
> absence of ceramic insert chipping events in the Trident™ group. The
> clinical data which established the efficacy of the Howmedica
> Osteonics^®^ ABC System has been used in support of the Trident™
> design. The results of the trial demonstrate that the ABC Systems (ABC
> I and ABC II) are safe and effective. The preclinical and the early
> safety and effectiveness comparisons of Trident to the ABC I, ABC II,
> and control system devices demonstrates that the Trident device is
> safe and effective.

XI. **[panel recommendations]{.smallcaps}**

> The PMA was presented to the Orthopedic and Rehabilitation Devices
> Advisory Committee (the Panel) on July 20, 2000. At that time the
> Panel recommended, based on a 7 -- 0 vote, that the ABC System (i.e.,
> both ABC System I and II) be found approvable with conditions. The
> conditions of approval suggested by the Panel included: disclosure to
> the surgeons in the technical manual as well as in the package insert
> concerning the chipping, brittleness, and revision limitations, etc.,
> of the ceramic components; basic science education on the material
> properties (e.g., corrosion, fracture, etc.) of the involved materials
> in addition to workshops; an extensive manual; monitoring of the
> surgeons; in-office training available in the form of either a CD ROM
> or a video; postmarket surveillance out to five years, including
> retrieval analysis; and wear testing on the subject components under a
> range of conditions a surgeon might encounter.
>
> The Panel also recommended, based on a 4 -- 3 vote, that the Trident™
> System be found not approvable based on a lack of 24-month follow-up
> data. To put the Trident™ System in approvable form the Panel
> recommended that the initial 2 year clinical study be completed. The
> Panel recommended the same approval conditions as identified above for
> the ABC System, with the exception of the revision limitations, as
> this is an advantage of the Trident™ System. In addition, the Panel
> recommended that corrosion testing be performed to demonstrate the
> potential for corrosion between the titanium insert sleeve and
> titanium acetabular shell.

####### FDA Decision

####### 

> FDA agreed with the Panel's recommendation for the ABC System
> (approvable with conditions). The sponsor submitted an amendment to
> the PMA that adequately addressed the conditions of approval
> recommended by the Panel. Therefore, since the conditions of approval
> have been met, FDA finds in favor of approval of the ABC System.
>
> FDA did not agree with the Panel's not approvable recommendation for
> the Trident™ System. The Panel had recommended that the 24-month
> clinical study be completed before consideration of approval and that
> corrosion testing should be performed. However, due to the
> similarities in the design of the ABC and Trident™ Systems FDA
> believes that the clinical data from the ABC System, along with the
> interoperative and perioperative clinical data from the Trident™ study
> compared to the ABC I, ABC II, and control devices, and pre-clinical
> testing on the Trident™ System compared to the ABC I, ABC II, and
> control devices is adequate to support approval of the Trident™
> System. Both systems use the identical articulating surface geometries
> and femoral stems. The only difference between the two systems is the
> locking mechanism between the acetabular insert and shell. Corrosion
> testing results evaluating the interface between the insert sleeve and
> acetabular shell were provided by the sponsor to address the concerns
> raised by the Panel.
>
> The Trident™ was developed to address the incidence of intraoperative
> chipping during insertion, and allow for revision of ceramic inserts.
> Although the Trident™ did not have long term (24-month) clinical data,
> none of the 183 Trident™ inserts implanted were chipped, compared to
> 16 incidences of insert chipping reported for the ABC System for a
> chipping rate of 3.4% (466 ABC System devices implanted overall,
> including continued access patients and those with less than 2 years
> follow-up). In addition, the adverse event rate out to six months
> post-operatively, is comparable to both the ABC System and Control
> System.
>
> Additional long-term concerns may be addressed through the completion
> of a post-market study and post-market surveillance. The sponsor has
> agreed to complete and extend the original 24-month study out to 60
> months on all 213 Trident cases and 328 ABC cases. Safety and
> effectiveness data will be collected as specified in the ABC/Trident
> IDE protocol, and reported annually until all patients have reached
> their 5 year post-operative follow-up. In addition, these patients
> will each be sent a postcard annually from six to ten years
> postoperatively to assess the patient's general well-being and if the
> study components are still in place. This will ultimately provide ten
> year survival data on a majority of the original study participants.
>
> FDA issued an approval letter to the applicant on February 3, 2003.
>
> Quality System Inspections were performed on 12/19/00 and 12/21/00 at
> the Stryker Howmedica Osteonics manufacturing sites in Allendale, NJ
> and Carrigwohil, Ireland, and on 11/22/02 at the ceramic supplier
> CeramTec of Plochingen, Germany, as well as on 10/16/01 and 4/25/02 at
> the contract sterilizers Steris Isomedix of Whippany, NJ and Morton
> Grove, Il, and on 11/12/01 at the contract sterilizer Gammaster
> Ireland of Westport, Ireland. Inspections revealed that the company
> was in compliance with the Quality System regulation (21 CFR Part
> 820).

####### xiii. APPROVAL SPECIFICATIONS {#xiii.-approval-specifications .unnumbered}

#######  {#section-3 .unnumbered}

Directions for use: See the Device Labeling

Hazards to Health from Use of the Device: See Indications,
Contraindications, Warnings, Precautions and Adverse Events in the
labeling

Post-approval Requirements and Restrictions: See approval order

**[TABLE 1: Time Course Distribution of Patient Accountability for ABC
System I, ABC System II, Trident™, and Control Systems.]{.underline}**

<table>
<colgroup>
<col style="width: 8%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 6%" />
<col style="width: 5%" />
<col style="width: 6%" />
<col style="width: 7%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 7%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 7%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
</colgroup>
<tbody>
<tr class="odd">
<td>Evaluation Interval</td>
<td colspan="3"><strong>ABC SYSTEM I</strong></td>
<td colspan="3"><strong>ABC SYSTEM II</strong></td>
<td colspan="3"><strong>CONTINUED ACCESS*</strong></td>
<td colspan="3"><strong>TRIDENT**</strong></td>
<td colspan="3"><h6 id="control">CONTROL</h6></td>
</tr>
<tr class="even">
<td></td>
<td>TFU</td>
<td>EFU</td>
<td><p>AFU</p>
<p>(%)</p></td>
<td>TFU</td>
<td>EFU</td>
<td><p>AFU</p>
<p>(%)</p></td>
<td>TFU</td>
<td>EFU</td>
<td><p>AFU</p>
<p>(%)</p></td>
<td>TFU</td>
<td>EFU</td>
<td><p>AFU</p>
<p>(%)</p></td>
<td>TFU</td>
<td>EFU</td>
<td><p>AFU</p>
<p>(%)</p></td>
</tr>
<tr class="odd">
<td>Pre-Op</td>
<td>172</td>
<td>172</td>
<td><p>172</p>
<p>(100%)</p></td>
<td>177</td>
<td>177</td>
<td><p>177</p>
<p>(100%)</p></td>
<td>114</td>
<td>114</td>
<td><p>114</p>
<p>(100%)</p></td>
<td>185</td>
<td>185</td>
<td><p>185</p>
<p>(100%)</p></td>
<td>165</td>
<td>165</td>
<td><p>165</p>
<p>(100%)</p></td>
</tr>
<tr class="even">
<td>7 weeks</td>
<td>172</td>
<td>172</td>
<td><p>170</p>
<p>(98.8%)</p></td>
<td>177</td>
<td>177</td>
<td><p>177</p>
<p>(100%)</p></td>
<td>114</td>
<td>114</td>
<td><p>113</p>
<p>(99.1%)</p></td>
<td>182</td>
<td>182</td>
<td><p>178</p>
<p>(97.8%)</p></td>
<td>165</td>
<td>165</td>
<td><p>163</p>
<p>(98.8%)</p></td>
</tr>
<tr class="odd">
<td>6 months</td>
<td>172</td>
<td>172</td>
<td><p>166</p>
<p>(96.5%)</p></td>
<td>177</td>
<td>177</td>
<td><p>167</p>
<p>(94.4%)</p></td>
<td></td>
<td></td>
<td></td>
<td>103</td>
<td>103</td>
<td><p>97</p>
<p>(94.2%)</p></td>
<td>165</td>
<td>164</td>
<td><p>157</p>
<p>(95.7%)</p></td>
</tr>
<tr class="even">
<td>12 months</td>
<td>172</td>
<td>171</td>
<td><p>168</p>
<p>(98.2%)</p></td>
<td>177</td>
<td>176</td>
<td><p>173</p>
<p>(98.3%)</p></td>
<td>86</td>
<td>86</td>
<td><p>77</p>
<p>(89.5%)</p></td>
<td></td>
<td></td>
<td></td>
<td>165</td>
<td>164</td>
<td><p>155</p>
<p>(94.5%)</p></td>
</tr>
<tr class="odd">
<td>24 months</td>
<td>140</td>
<td>139</td>
<td><p>131</p>
<p>(94.2%)</p></td>
<td>140</td>
<td>139</td>
<td><p>129</p>
<p>(92.8%)</p></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>133</td>
<td>131</td>
<td><p>119</p>
<p>(90.8%)</p></td>
</tr>
</tbody>
</table>

TFU = Theoretical Follow-Up; EFU = Expected Follow-Up; AFU = Actual
Follow-up

\*Continued Access cases include 3 with the ABC System I and 111 with
the ABC System II devices. No data was collected at the 6 month postop
interval for continued access patients. No continued access patients had
yet reached 24 months postoperatively at the time of data base closure.

\*\*No Trident patients had yet reached 12 months postoperatively at the
time of data base closure.

> **[TABLE 2: Primary Efficacy Assessments for ABC System I and ABC
> System II vs. Control System. Efficacy assessment based on mean Harris
> Hip Score (HHS) and radiographic success reported for those cases with
> 2 year follow-up data.]{.underline}**

+--------------------+----------------+-----------------+-------------+
| **Primary          | **ABC SYSTEM   | **ABC SYSTEM    | **CONTROL** |
| Efficacy**         | I**            | II**            |             |
|                    |                |                 | 133 cases   |
| **Assessment**     | 140 cases      | 140 cases       | enrolled    |
|                    | enrolled       | enrolled        |             |
+--------------------+----------------+-----------------+-------------+
| Preoperative mean  | 49.6 (19.3 -   | 49.0 (24.7 -    | 49.3        |
| HHS                | 89.6)          | 75.2)           | (21.4 -     |
|                    |                |                 | 87.3)       |
| (range)            | n=126          | n=131           |             |
|                    |                |                 | n=125       |
+--------------------+----------------+-----------------+-------------+
| 2 year postop mean | 96.3 (48.0 -   | 96.9 (56.9 -    | 95.1        |
| HHS                | 100)           | 100)            | (58.8 -     |
|                    |                |                 | 100)        |
| (range)            | n=122          | n=120           |             |
|                    |                |                 | n=110       |
+--------------------+----------------+-----------------+-------------+
| \% Excellent/Good  | 95.9%          | 96.7%           | 93.6%       |
| Results            |                |                 |             |
|                    | (117/122)      | (116/120)       | (103/110)   |
| (HHS 80-100        |                |                 |             |
| points) at 2 years |                |                 |             |
|                    |                |                 |             |
| postop             |                |                 |             |
+--------------------+----------------+-----------------+-------------+
| \% Total HHS 70 at | 98.4%          | 99.2%           | 98.2%       |
| 2 years            |                |                 |             |
|                    | (120/122)      | (119/120)       | (108/110)   |
| postop             |                |                 |             |
+--------------------+----------------+-----------------+-------------+
| \% Radiographic    | 100%           | 99.2%           | 100%        |
| Success at 2       |                |                 |             |
|                    | (123/123)      | (121/122)       | (113/113)   |
| years postop       |                |                 |             |
+--------------------+----------------+-----------------+-------------+

n = number of cases that had evaluable data

###### [TABLE 3: Time Course Distribution of Operative Site Adverse Event Incidences for ABC System I and ABC System II vs. Control System out to 24 Months Post-Operatively.]{.underline}

<table>
<colgroup>
<col style="width: 16%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
</colgroup>
<tbody>
<tr class="odd">
<td><strong>Operative Site Related</strong></td>
<td colspan="6"><p><strong>ABC SYSTEM I<sup>1</sup></strong></p>
<p><strong>(172 cases enrolled)</strong></p></td>
<td colspan="6"><p><strong>ABC SYSTEM II<sup>2</sup></strong></p>
<p><strong>(177 cases enrolled)</strong></p></td>
<td colspan="4"><p><strong>CONT. ACCESS*</strong></p>
<p><strong>(114 enrolled)</strong></p></td>
<td colspan="6"><p><strong>CONTROL</strong></p>
<p><strong>(165 cases enrolled)</strong></p></td>
</tr>
<tr class="even">
<td>Visit</td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>12</strong></td>
<td><strong>24</strong></td>
<td><strong>Tot</strong></td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>12</strong></td>
<td><strong>24</strong></td>
<td><strong>Tot</strong></td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>12</strong></td>
<td><strong>Tot</strong></td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>12</strong></td>
<td><strong>24</strong></td>
<td><strong>Tot</strong></td>
</tr>
<tr class="odd">
<td>N = cases evaluated</td>
<td>172</td>
<td>170</td>
<td>166</td>
<td>168</td>
<td>131</td>
<td></td>
<td>177</td>
<td>177</td>
<td>167</td>
<td>173</td>
<td>129</td>
<td></td>
<td>114</td>
<td>113</td>
<td>77</td>
<td></td>
<td>165</td>
<td>163</td>
<td>157</td>
<td>155</td>
<td>119</td>
<td></td>
</tr>
<tr class="even">
<td>Revision: Femoral</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td>2</td>
</tr>
<tr class="odd">
<td>Acetabular</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
</tr>
<tr class="even">
<td>Acetabular Insert</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td>2</td>
<td>4</td>
</tr>
<tr class="odd">
<td>Femoral Head</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td>2</td>
<td>4</td>
</tr>
<tr class="even">
<td>All Components</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Femoral Fracture/Crack</td>
<td>6</td>
<td>3</td>
<td>1</td>
<td></td>
<td></td>
<td>10</td>
<td>7</td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td>9</td>
<td>4</td>
<td></td>
<td></td>
<td>4</td>
<td>7</td>
<td>1</td>
<td>1</td>
<td></td>
<td></td>
<td>9</td>
</tr>
<tr class="even">
<td>Trochanteric Frac/Crack</td>
<td>4</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>4</td>
<td>3</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>3</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
</tr>
<tr class="odd">
<td>Acetabular Frac/Crack</td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Loosening: Fem. Comp</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Acetabular Comp</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Both Comp</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Superficial Infection</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>4</td>
<td></td>
<td></td>
<td></td>
<td>4</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>5</td>
<td></td>
<td></td>
<td></td>
<td>5</td>
</tr>
<tr class="even">
<td>Deep Joint Infection</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td>2</td>
</tr>
<tr class="odd">
<td>Hematoma</td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
</tr>
<tr class="even">
<td>Wound Related</td>
<td></td>
<td>8</td>
<td></td>
<td></td>
<td></td>
<td>8</td>
<td></td>
<td>8</td>
<td></td>
<td></td>
<td></td>
<td>8</td>
<td></td>
<td>4</td>
<td></td>
<td>4</td>
<td>1</td>
<td>6</td>
<td></td>
<td></td>
<td></td>
<td>7</td>
</tr>
<tr class="odd">
<td>Dislocation: Single</td>
<td></td>
<td>4</td>
<td></td>
<td></td>
<td></td>
<td>4</td>
<td></td>
<td>5</td>
<td></td>
<td></td>
<td></td>
<td>5</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td>1</td>
<td>3</td>
<td></td>
<td></td>
<td>1</td>
<td>5</td>
</tr>
<tr class="even">
<td>Recurrent</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td>2</td>
</tr>
<tr class="odd">
<td>Nerve Palsy</td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Subluxation</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td>1</td>
</tr>
<tr class="odd">
<td>Excessive Hip Pain</td>
<td>1</td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td>2</td>
</tr>
<tr class="even">
<td>Bursitis</td>
<td></td>
<td>1</td>
<td>1</td>
<td>2</td>
<td>1</td>
<td>5</td>
<td></td>
<td></td>
<td>4</td>
<td>4</td>
<td></td>
<td>8</td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
<td></td>
<td>1</td>
<td>1</td>
<td>3</td>
<td></td>
<td>5</td>
</tr>
<tr class="odd">
<td>Heterotopic bone</td>
<td></td>
<td>3</td>
<td>2</td>
<td></td>
<td></td>
<td>5</td>
<td></td>
<td>3</td>
<td>3</td>
<td></td>
<td></td>
<td>6</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>6</td>
<td>4</td>
<td></td>
<td></td>
<td>10</td>
</tr>
<tr class="even">
<td>Subsidence</td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Trochanteric non-union</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Soft Tissue Trauma</td>
<td></td>
<td></td>
<td>2</td>
<td>2</td>
<td>1</td>
<td>5</td>
<td></td>
<td></td>
<td>1</td>
<td>5</td>
<td></td>
<td>6</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td>1</td>
<td>3</td>
<td></td>
<td>5</td>
</tr>
<tr class="odd">
<td>Alumina Insert Chip</td>
<td>4</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>4</td>
<td>4</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>4</td>
<td>6</td>
<td></td>
<td></td>
<td>6</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Miscellaneous</td>
<td>2</td>
<td>5</td>
<td>3</td>
<td>2</td>
<td></td>
<td>12</td>
<td>4</td>
<td>3</td>
<td>1</td>
<td>4</td>
<td></td>
<td>12</td>
<td>2</td>
<td>2</td>
<td></td>
<td>4</td>
<td>3</td>
<td>6</td>
<td>2</td>
<td>3</td>
<td>2</td>
<td>16</td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><strong>TOTAL</strong></td>
<td>20</td>
<td>28</td>
<td>10</td>
<td>8</td>
<td>2</td>
<td><strong>68</strong></td>
<td>18</td>
<td>32</td>
<td>10</td>
<td>15</td>
<td>0</td>
<td><strong>75</strong></td>
<td>13</td>
<td>9</td>
<td>1</td>
<td><strong>23</strong></td>
<td>13</td>
<td>38</td>
<td>12</td>
<td>11</td>
<td>8</td>
<td><strong>82</strong></td>
</tr>
</tbody>
</table>

io = intraoperatively; ea = early (7 weeks); 6 = 6 months; 12 =12
months; 24 = 24 months postoperative; Tot = total

data for ABC I, ABC II, and Control includes those cases with less than
24 month postoperative follow-up

\*includes 3 cases with ABC System I and 113 cases with ABC System II
out to 12 months postoperative follow-up at time of data base closure. A
6 month evaluation was not performed on these cases.

###### ^1^ABC System I utilized Howmedica Osteonics® PSL® MicroStructured® ABC Shells; ^2^ABC System II utilized Howmedica Osteonics® Secur-Fit™-HA PSL® ABC Shells

values represent the number of *components* revised, this does not
correspond to the number of *patients* (*cases)* that were revised.

###### 

###### 

###### 

###### 

###### 

###### 

###### [TABLE 4: Time Course Distribution of Systemic Adverse Event Incidences for ABC System I and ABC System II vs. Control System out to 24 Months Post-Operatively.]{.underline}

<table>
<colgroup>
<col style="width: 18%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 4%" />
<col style="width: 2%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 4%" />
<col style="width: 2%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
</colgroup>
<tbody>
<tr class="odd">
<td><strong>Systemic Medical Events</strong></td>
<td colspan="6"><p><strong>ABC SYSTEM I<sup>1</sup></strong></p>
<p><strong>(163 patients enrolled)</strong></p></td>
<td colspan="6"><p><strong>ABC SYSTEM II<sup>2</sup></strong></p>
<p><strong>(172 patients enrolled)</strong></p></td>
<td colspan="4"><p><strong>CONTINUED ACCESS*</strong></p>
<p><strong>(107 patients enrolled)</strong></p></td>
<td colspan="6"><p><strong>CONTROL</strong></p>
<p><strong>(161 patients enrolled)</strong></p></td>
</tr>
<tr class="even">
<td>Visit</td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>12</strong></td>
<td><strong>24</strong></td>
<td><strong>Tot</strong></td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>12</strong></td>
<td><strong>24</strong></td>
<td><strong>Tot</strong></td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>12</strong></td>
<td><strong>Tot</strong></td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>12</strong></td>
<td><strong>24</strong></td>
<td><strong>Tot</strong></td>
</tr>
<tr class="odd">
<td>Death</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>2</td>
<td>3</td>
</tr>
<tr class="even">
<td>Pulmonary Embolism</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td>2</td>
</tr>
<tr class="odd">
<td>Thrombus</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td>2</td>
</tr>
<tr class="even">
<td>Urinary Tract Infection</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
<td>1</td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td>2</td>
</tr>
<tr class="odd">
<td>Genitourinary (non UTI)</td>
<td>2</td>
<td>5</td>
<td></td>
<td></td>
<td></td>
<td>7</td>
<td>3</td>
<td>2</td>
<td>2</td>
<td>1</td>
<td></td>
<td>8</td>
<td>2</td>
<td></td>
<td></td>
<td>2</td>
<td>4</td>
<td>4</td>
<td>2</td>
<td></td>
<td></td>
<td>10</td>
</tr>
<tr class="even">
<td>Carcinoma</td>
<td></td>
<td>1</td>
<td>1</td>
<td>2</td>
<td></td>
<td>4</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
<td>2</td>
</tr>
<tr class="odd">
<td>Bronchiopulmonary</td>
<td>1</td>
<td></td>
<td>3</td>
<td></td>
<td></td>
<td>4</td>
<td></td>
<td>2</td>
<td>1</td>
<td></td>
<td></td>
<td>3</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td>1</td>
<td></td>
<td>1</td>
<td>3</td>
</tr>
<tr class="even">
<td>Cardiovascular</td>
<td>4</td>
<td>4</td>
<td></td>
<td>4</td>
<td>1</td>
<td>13</td>
<td>3</td>
<td>2</td>
<td>1</td>
<td>1</td>
<td></td>
<td>7</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td>1</td>
<td>5</td>
<td>1</td>
<td>2</td>
<td>1</td>
<td>10</td>
</tr>
<tr class="odd">
<td>Gastrointestinal</td>
<td>1</td>
<td>5</td>
<td></td>
<td>1</td>
<td>2</td>
<td>9</td>
<td>1</td>
<td>2</td>
<td></td>
<td></td>
<td>1</td>
<td>4</td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
<td></td>
<td>3</td>
<td>1</td>
<td></td>
<td></td>
<td>4</td>
</tr>
<tr class="even">
<td>Neurosensory</td>
<td>1</td>
<td>3</td>
<td>1</td>
<td>5</td>
<td>1</td>
<td>11</td>
<td></td>
<td>2</td>
<td>1</td>
<td>3</td>
<td>1</td>
<td>7</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td>1</td>
<td>2</td>
<td>1</td>
<td>2</td>
<td>1</td>
<td>7</td>
</tr>
<tr class="odd">
<td>Trauma (non-op hip related)</td>
<td></td>
<td></td>
<td>3</td>
<td>3</td>
<td>1</td>
<td>7</td>
<td></td>
<td></td>
<td>2</td>
<td>3</td>
<td>1</td>
<td>6</td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
<td></td>
<td></td>
<td>2</td>
<td>6</td>
<td>1</td>
<td>9</td>
</tr>
<tr class="even">
<td>Dermatologic</td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
<td>2</td>
<td></td>
<td>2</td>
<td></td>
<td>3</td>
<td></td>
<td>5</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
<td>1</td>
<td></td>
<td></td>
<td>3</td>
</tr>
<tr class="odd">
<td>Miscellaneous</td>
<td>1</td>
<td>7</td>
<td>6</td>
<td>5</td>
<td>5</td>
<td>24</td>
<td>1</td>
<td>8</td>
<td>4</td>
<td>11</td>
<td>2</td>
<td>26</td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
<td></td>
<td>6</td>
<td>6</td>
<td>5</td>
<td>1</td>
<td>18</td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td><strong>TOTAL</strong></td>
<td>10</td>
<td>27</td>
<td>14</td>
<td>22</td>
<td>11</td>
<td><strong>84</strong></td>
<td>8</td>
<td>23</td>
<td>11</td>
<td>22</td>
<td>5</td>
<td><strong>69</strong></td>
<td>3</td>
<td>12</td>
<td>1</td>
<td><strong>16</strong></td>
<td>7</td>
<td>26</td>
<td>17</td>
<td>16</td>
<td>9</td>
<td><strong>75</strong></td>
</tr>
</tbody>
</table>

io = intraoperatively; ea = early (7 weeks); 6 = 6 months; 12 =12
months; 24 = 24 months postoperative

data for ABC I, ABC II, and Control includes those cases with less than
24 month postoperative follow-up

\*includes data from 3 cases with ABC System I and 113 cases with ABC
System II out to 12 months postoperative follow-up at time of data base
closure

\*\* 103 cases out to 6 months postoperative follow-up at time of data
base closure

###### ^1^ABC System I utilized Howmedica Osteonics® PSL® MicroStructured® ABC Shells; ^2^ABC System II utilized Howmedica Osteonics® Secur-Fit™-HA PSL® ABC Shells

> **[TABLE 5: 2 Year Patient Success Rates]{.underline}**

+-----------------------------+-----------+----------+----------------+
| **Patient Success           | **ABC     | **ABC    | **CONTROL**    |
| Criteria**                  | I^1^**    | II^2^**  |                |
|                             |           |          | 133 cases      |
|                             | 140 cases | 140      | enrolled       |
|                             | enrolled  | cases    |                |
|                             |           | enrolled |                |
+-----------------------------+-----------+----------+----------------+
| Abscence of Revision (%)    | 139 / 140 | 138 /    | 128 / 133      |
|                             |           | 140      |                |
|                             | (99.3%)   |          | (96.2%)        |
|                             |           | (98.6%)  |                |
+-----------------------------+-----------+----------+----------------+
| Total HHS 70                | 120 / 122 | 119 /    | 117 / 120\*\*  |
|                             |           | 121\*    |                |
|                             | (98.4%)   |          | (97.5%)        |
|                             |           | (98.4%)  |                |
|                             |           |          |                |
|                             |           | n=121    |                |
+-----------------------------+-----------+----------+----------------+
| Acetabular RLL              | 122 / 122 | 120 /    | 112 / 112      |
| [\<]{.underline}2mm         |           | 120      |                |
|                             | (100%)    |          | (100%)         |
|                             |           | (100%)   |                |
+-----------------------------+-----------+----------+----------------+
| Acetabular Migration        | 122 / 122 | 120 /    | 112 / 112      |
| [\<]{.underline}3mm         |           | 120      |                |
|                             | (100%)    |          | (100%)         |
|                             |           | (100%)   |                |
+-----------------------------+-----------+----------+----------------+
| Wear Acetabular Insert      | 122 / 122 | 120 /    | 112 / 112      |
| \<0.5mm/yr                  |           | 120      |                |
|                             | (100%)    |          | (100%)         |
|                             |           | (100%)   |                |
+-----------------------------+-----------+----------+----------------+
| Femoral RLL                 | 118 / 118 | 115 /    | 110 / 110      |
| [\<]{.underline}2mm         |           | 115      |                |
|                             | (100%)    |          | (100%)         |
|                             |           | (100%)   |                |
+-----------------------------+-----------+----------+----------------+
| Progressive Femoral         | 122 / 122 | 119 /    | 111 / 111      |
| Component Subsidence        |           | 120      |                |
| [\<]{.underline}5mm         | (100%)    |          | (100%)         |
|                             |           | (99.2%)  |                |
+-----------------------------+-----------+----------+----------------+
| **Patient Success Rate**    | 97.5%     | 95.8%    | 93.2%          |
|                             |           |          |                |
|                             | (118/121) | (        | (110/118)      |
|                             |           | 115/120) |                |
+-----------------------------+-----------+----------+----------------+

> \* One case with HHS \<70 at 12 months, and no 24 month follow-up and
> is included
>
> \*\* One case, with HHS \<70 at 12 months, died before 24 month
> follow-up and is included

######  ^1^ABC System I utilized Howmedica Osteonics® PSL® MicroStructured® ABC Shells; ^2^ABC System II utilized Howmedica Osteonics® Secur-Fit™-HA PSL® ABC Shells

**[TABLE 6: Time Course Distribution Table that compares early
effectiveness data (mean Harris Hip Score - HHS) of the
Trident™]{.underline} [System to the ABC System I, ABC System II, and
Control System data.]{.underline}**

<table style="width:100%;">
<colgroup>
<col style="width: 14%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 8%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 7%" />
<col style="width: 6%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 7%" />
</colgroup>
<tbody>
<tr class="odd">
<td><strong>Summary of Effectiveness Data</strong></td>
<td colspan="3"><h6 id="abc-system-i1">ABC SYSTEM
I<sup>1</sup></h6></td>
<td colspan="3"><h6 id="abc-system-ii2">ABC SYSTEM
II<sup>2</sup></h6></td>
<td colspan="3"><h6 id="trident">TRIDENT</h6></td>
<td colspan="3"><h6 id="control-1">CONTROL</h6></td>
</tr>
<tr class="even">
<td>Visit</td>
<td>Pre-Op</td>
<td>7 weeks</td>
<td>6 months</td>
<td>Pre-Op</td>
<td>7 weeks</td>
<td>6 months</td>
<td>Pre-Op</td>
<td>7 weeks</td>
<td>6 months</td>
<td>Pre-Op</td>
<td>7 weeks</td>
<td>6 months</td>
</tr>
<tr class="odd">
<td>N=evaluable cases</td>
<td>170</td>
<td>162</td>
<td>162</td>
<td>176</td>
<td>177</td>
<td>166</td>
<td>184</td>
<td>175</td>
<td>97</td>
<td>165</td>
<td>160</td>
<td>156</td>
</tr>
<tr class="even">
<td><p>HHS</p>
<p>(Std)</p></td>
<td><p>48.3</p>
<p>(13.0)</p></td>
<td><p>78.6</p>
<p>(11.4)</p></td>
<td><p>93.2</p>
<p>(9.6)</p></td>
<td><p>48.7</p>
<p>(10.7)</p></td>
<td><p>79.2</p>
<p>(13.1)</p></td>
<td><p>94.7</p>
<p>(7.8)</p></td>
<td><p>47.5</p>
<p>(11.7)</p></td>
<td><p>80.3</p>
<p>(9.8)</p></td>
<td><p>95.4</p>
<p>(7.4)</p></td>
<td><p>48.9</p>
<p>(12.3)</p></td>
<td><p>77.3</p>
<p>(10.1)</p></td>
<td><p>91.7</p>
<p>(10.7)</p></td>
</tr>
</tbody>
</table>

###### ^1^ABC System I utilized Howmedica Osteonics® PSL® MicroStructured® ABC Shells; ^2^ABC System II utilized Howmedica Osteonics® Secur-Fit™-HA PSL® ABC Shells

###### 

###### 

###### [TABLE 7: Time Course Distribution of Operative Site Adverse Event Incidences for the Trident™ System vs. ABC I, ABC II and Control Systems out to Six Months Post-Operatively.]{.underline}

<table>
<colgroup>
<col style="width: 20%" />
<col style="width: 4%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td><strong>Operative Site Related</strong></td>
<td colspan="4"><p><strong>ABC SYSTEM I<sup>1</sup></strong></p>
<p><strong>(172 cases enrolled)</strong></p></td>
<td colspan="4"><p><strong>ABC SYSTEM II<sup>2</sup></strong></p>
<p><strong>(177 cases enrolled)</strong></p></td>
<td colspan="4"><p><strong>TRIDENT*</strong></p>
<p><strong>(185 enrolled)</strong></p></td>
<td colspan="4"><p><strong>CONTROL</strong></p>
<p><strong>(165 enrolled)</strong></p></td>
</tr>
<tr class="even">
<td>Visit</td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>Tot</strong></td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>Tot</strong></td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>Tot</strong></td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>Tot</strong></td>
</tr>
<tr class="odd">
<td>N = cases evaluated</td>
<td>172</td>
<td>170</td>
<td>166</td>
<td></td>
<td>177</td>
<td>177</td>
<td>167</td>
<td></td>
<td>185</td>
<td>178</td>
<td>97</td>
<td></td>
<td>165</td>
<td>163</td>
<td>157</td>
<td></td>
</tr>
<tr class="even">
<td>Revision: Femoral</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
</tr>
<tr class="odd">
<td>Acetabular</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Acetabular Insert</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
</tr>
<tr class="odd">
<td>Femoral Head</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
</tr>
<tr class="even">
<td>All Components</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Femoral Fracture/Crack</td>
<td>6</td>
<td>3</td>
<td>1</td>
<td>10</td>
<td>7</td>
<td>2</td>
<td></td>
<td>9</td>
<td>3</td>
<td>1</td>
<td></td>
<td>4</td>
<td>7</td>
<td>1</td>
<td>1</td>
<td>9</td>
</tr>
<tr class="even">
<td>Trochanteric Frac/Crack</td>
<td>4</td>
<td></td>
<td></td>
<td>4</td>
<td>3</td>
<td></td>
<td></td>
<td>3</td>
<td>3</td>
<td></td>
<td></td>
<td>3</td>
<td>1</td>
<td></td>
<td></td>
<td>1</td>
</tr>
<tr class="odd">
<td>Acetabular Frac/Crack</td>
<td>2</td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Loosening: Fem. Comp</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Acetabular Comp</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Both Comp</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Superficial Infection</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td>4</td>
<td></td>
<td>4</td>
<td></td>
<td>4</td>
<td></td>
<td>4</td>
<td></td>
<td>5</td>
<td></td>
<td>5</td>
</tr>
<tr class="even">
<td>Deep Joint Infection</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
</tr>
<tr class="odd">
<td>Hematoma</td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>3</td>
<td></td>
<td>3</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
</tr>
<tr class="even">
<td>Wound Related</td>
<td></td>
<td>8</td>
<td></td>
<td>8</td>
<td></td>
<td>8</td>
<td></td>
<td>8</td>
<td></td>
<td>14</td>
<td></td>
<td>14</td>
<td>1</td>
<td>6</td>
<td></td>
<td>7</td>
</tr>
<tr class="odd">
<td>Dislocation: Single</td>
<td></td>
<td>4</td>
<td></td>
<td>4</td>
<td></td>
<td>5</td>
<td></td>
<td>5</td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
<td>1</td>
<td>3</td>
<td></td>
<td>4</td>
</tr>
<tr class="even">
<td>Recurrent</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
</tr>
<tr class="odd">
<td>Nerve Palsy</td>
<td>1</td>
<td></td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Subluxation</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
</tr>
<tr class="odd">
<td>Excessive Hip Pain</td>
<td>1</td>
<td>1</td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
<td></td>
<td>1</td>
<td>1</td>
<td>2</td>
<td></td>
<td></td>
<td>2</td>
<td>2</td>
</tr>
<tr class="even">
<td>Bursitis</td>
<td></td>
<td>1</td>
<td>1</td>
<td>2</td>
<td></td>
<td></td>
<td>4</td>
<td>4</td>
<td></td>
<td>3</td>
<td>1</td>
<td>4</td>
<td></td>
<td>1</td>
<td>1</td>
<td>2</td>
</tr>
<tr class="odd">
<td>Heterotopic bone</td>
<td></td>
<td>3</td>
<td>2</td>
<td>5</td>
<td></td>
<td>3</td>
<td>3</td>
<td>6</td>
<td></td>
<td>5</td>
<td></td>
<td>5</td>
<td></td>
<td>6</td>
<td>4</td>
<td>10</td>
</tr>
<tr class="even">
<td>Subsidence</td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Trochanteric non-union</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Soft Tissue Trauma</td>
<td></td>
<td></td>
<td>2</td>
<td>2</td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
<td></td>
<td>1</td>
<td>1</td>
<td>2</td>
<td></td>
<td>1</td>
<td>1</td>
<td>2</td>
</tr>
<tr class="odd">
<td>Alumina Insert Chip</td>
<td>4</td>
<td></td>
<td></td>
<td>4</td>
<td>4</td>
<td></td>
<td></td>
<td>4</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Miscellaneous</td>
<td>2</td>
<td>5</td>
<td>3</td>
<td>10</td>
<td>4</td>
<td>3</td>
<td>1</td>
<td>8</td>
<td>2</td>
<td>4</td>
<td>4</td>
<td>10</td>
<td>3</td>
<td>6</td>
<td>2</td>
<td>11</td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><strong>TOTAL</strong></td>
<td>20</td>
<td>28</td>
<td>10</td>
<td><strong>58</strong></td>
<td>18</td>
<td>32</td>
<td>10</td>
<td><strong>60</strong></td>
<td>10</td>
<td>40</td>
<td>7</td>
<td><strong>57</strong></td>
<td>13</td>
<td>38</td>
<td>12</td>
<td><strong>63</strong></td>
</tr>
</tbody>
</table>

io = intraoperatively; ea = early (7 weeks); 6 = 6 months postoperative;
Tot = total

data for ABC I, ABC II, and Control includes those cases with less than
24 month postoperative follow-up

\* 103 cases out to 6 months postoperative follow-up at time of data
base closure

###### ^1^ABC System I utilized Howmedica Osteonics® PSL® MicroStructured® ABC Shells; ^2^ABC System II utilized Howmedica Osteonics® Secur-Fit™-HA PSL® ABC Shells

values represent the number of *components* revised, this does not
correspond to the number of *patients* (*cases)* that were revised.

###### 

###### 

###### 

###### 

###### [TABLE 8: Time Course Distribution of Systemic Adverse Event Incidences for Trident™ vs. ABC System I, ABC System II, and the Control Systems at Six Months Post-Operatively.]{.underline}

<table>
<colgroup>
<col style="width: 25%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 0%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 0%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 3%" />
<col style="width: 5%" />
<col style="width: 3%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td><strong>Systemic Medical Events</strong></td>
<td colspan="5"><p><strong>ABC SYSTEM I<sup>1</sup></strong></p>
<p><strong>(163 patients enrolled)</strong></p></td>
<td colspan="5"><p><strong>ABC SYSTEM II<sup>2</sup></strong></p>
<p><strong>(172 patients enrolled)</strong></p></td>
<td colspan="4"><p><strong>TRIDENT*</strong></p>
<p><strong>(173 patients enrolled)</strong></p></td>
<td colspan="4"><p><strong>CONTROL</strong></p>
<p><strong>(161 patients enrolled)</strong></p></td>
</tr>
<tr class="even">
<td>Visit</td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>Tot</strong></td>
<td colspan="2"><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>Tot</strong></td>
<td colspan="2"><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>Tot</strong></td>
<td><strong>io</strong></td>
<td><strong>ea</strong></td>
<td><strong>6</strong></td>
<td><strong>Tot</strong></td>
</tr>
<tr class="odd">
<td>Death</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
</tr>
<tr class="even">
<td>Pulmonary Embolism</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td>1</td>
<td></td>
<td>1</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
</tr>
<tr class="odd">
<td>Thrombus</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td colspan="2"></td>
<td>1</td>
<td></td>
<td>1</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
</tr>
<tr class="even">
<td>Urinary Tract Infection</td>
<td></td>
<td>1</td>
<td></td>
<td>1</td>
<td colspan="2"></td>
<td>1</td>
<td></td>
<td>1</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>2</td>
<td></td>
<td>2</td>
</tr>
<tr class="odd">
<td>Genitourinary (non UTI)</td>
<td>2</td>
<td>5</td>
<td></td>
<td>7</td>
<td colspan="2">3</td>
<td>2</td>
<td>2</td>
<td>7</td>
<td colspan="2"></td>
<td>5</td>
<td></td>
<td>5</td>
<td>4</td>
<td>4</td>
<td>2</td>
<td>10</td>
</tr>
<tr class="even">
<td>Carcinoma</td>
<td></td>
<td>1</td>
<td>1</td>
<td>2</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Bronchiopulmonary</td>
<td>1</td>
<td></td>
<td>3</td>
<td>4</td>
<td colspan="2"></td>
<td>2</td>
<td>1</td>
<td>3</td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td>1</td>
<td>1</td>
<td>2</td>
</tr>
<tr class="even">
<td>Cardiovascular</td>
<td>4</td>
<td>4</td>
<td></td>
<td>8</td>
<td colspan="2">3</td>
<td>2</td>
<td>1</td>
<td>6</td>
<td colspan="2">2</td>
<td>7</td>
<td>1</td>
<td>10</td>
<td>1</td>
<td>5</td>
<td>1</td>
<td>7</td>
</tr>
<tr class="odd">
<td>Gastrointestinal</td>
<td>1</td>
<td>5</td>
<td></td>
<td>6</td>
<td colspan="2">1</td>
<td>2</td>
<td></td>
<td>3</td>
<td colspan="2">1</td>
<td>9</td>
<td></td>
<td>10</td>
<td></td>
<td>3</td>
<td>1</td>
<td>4</td>
</tr>
<tr class="even">
<td>Neurosensory</td>
<td>1</td>
<td>3</td>
<td>1</td>
<td>5</td>
<td colspan="2"></td>
<td>2</td>
<td>1</td>
<td>3</td>
<td colspan="2">1</td>
<td>2</td>
<td>1</td>
<td>4</td>
<td>1</td>
<td>2</td>
<td>1</td>
<td>4</td>
</tr>
<tr class="odd">
<td>Trauma (non-op hip related)</td>
<td></td>
<td></td>
<td>3</td>
<td>3</td>
<td colspan="2"></td>
<td></td>
<td>2</td>
<td>2</td>
<td colspan="2"></td>
<td>1</td>
<td></td>
<td>1</td>
<td></td>
<td></td>
<td>2</td>
<td>2</td>
</tr>
<tr class="even">
<td>Dermatologic</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td>2</td>
<td></td>
<td>2</td>
<td colspan="2"></td>
<td>3</td>
<td></td>
<td>3</td>
<td>1</td>
<td>1</td>
<td>1</td>
<td>3</td>
</tr>
<tr class="odd">
<td>Miscellaneous</td>
<td>1</td>
<td>7</td>
<td>6</td>
<td>14</td>
<td colspan="2">1</td>
<td>8</td>
<td>4</td>
<td>13</td>
<td colspan="2">3</td>
<td>21</td>
<td>2</td>
<td>26</td>
<td></td>
<td>6</td>
<td>6</td>
<td>12</td>
</tr>
<tr class="even">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td><strong>TOTAL</strong></td>
<td>10</td>
<td>27</td>
<td>14</td>
<td><strong>51</strong></td>
<td colspan="2">8</td>
<td>23</td>
<td>11</td>
<td><strong>42</strong></td>
<td colspan="2">7</td>
<td>48</td>
<td>4</td>
<td><strong>59</strong></td>
<td>7</td>
<td>26</td>
<td>17</td>
<td><strong>50</strong></td>
</tr>
</tbody>
</table>

io = intraoperatively; ea = early (7 weeks); 6 = 6 months postoperative;
Tot = total.

This table does not include data from the 107 Continued Access patients
(see Table X)

All patients enrolled in the ABC I, ABC II, and Control groups have
achieved at least 12 months postoperative follow-up.

\* 103 cases out to 6 months postoperative follow-up at time of data
base closure.

###### ^1^ABC System I utilized Howmedica Osteonics® PSL® MicroStructured® ABC Shells; ^2^ABC System II utilized Howmedica Osteonics® Secur-Fit™-HA PSL® ABC Shells