S M I T H & N E P H E W

REFLECTION
®

I&V
POROUS-COATED
™

ACETABULAR COMPONENT™

SURGICAL TECHNIQUE
REFLECTION
I&V
POROUS-COATED ™

ACETABULAR COMPONENT ™

designed in conjunction with

Ramon B. Gustilo, M.D.

Richard F. Kyle, M.D.

Nota Bene: This technique description herein is

made available to the healthcare professional
to illustrate the authors’ suggested treatment
for the uncomplicated procedure. In the final
analysis, the preferred treatment is that which
addresses the needs of the patient.
 I N T R O D U C T I O N

The Reflection Acetabular System has incor- The Reflection Acetabular System is avail-
porated several design features to address able in several shell configurations. This
the problem of small particle polyethylene technique describes the Reflection I and V
debris generation. shells. Reflection I has a threaded apex hole
for cup insertion and visualization of the
To maximize stability of the liner in the
acetabulum. Reflection I is available in out-
shell, the MicroStable® liner locking mecha-
side diameters, 42-70 mm in 2 mm incre-
nism combines the axial and rotational lock
ments. Reflection I does not offer any type of
in one noninvasive mechanism. To further
adjunctive fixation options. Reflection V has
reduce polyethylene debris, the inner shell
five screw/peg holes in sizes 46–70 mm.
surface is polished to a mirror smooth finish.
Reflection V 44 mm shell diameter has three
This patented, highly polished inner surface,
holes for adjunctive fixation.
combined with the MicroStable liner locking
mechanism minimize polyethylene debris. Hole covers are available for shell closure.
Reflection liners are now sterilized by a non- A threaded hole cover can be threaded into
degrading method to eliminate damage the apex hole of the Reflection I or V shell.
associated with gamma sterilization. Tapered hole covers are available to close
the screw/peg holes on Reflection V.
Another enhancing design feature is liner/
shell congruency. By maximizing the con- The Reflection MicroStable liner locking
gruity between cup and liner, a better mechanism, highly polished inner surface,
distribution of forces lowers the amount of and improved cup and liner congruity, pro-
contact stresses in the polyethylene liner vide a better way to reduce polyethylene
which results in lower wear rates. To assure debris.
a good fit between liner and shell, a post-
sintering machining process ensures precise
tolerances.
For added stability, Reflection V incorporates
ExtrusionLock™ modular pegs for stable fix-
ation of the shell to the acetabulum. These
pegs lock into the shell, further reducing the
likelihood of generating poly or metal
debris.

2
 P R E O P E R AT I V E P L A N N I N G

Preoperative templating is essential to the precise

reconstruction of the hip joint. Suggested preopera-
tive X-rays include an A-P of the pelvis and hips, a
14" x 17" A-P view of the affected hip and femur, and
a lateral view of the affected hip.
The acetabular component may be templated using
the contralateral normal hip, if available, or
templated directly on the affected hip. The acetabular
component should congruently fit the subchondral
bone and the medial aspect of the acetabulum as
indicated by the teardrop. Mark the center of rotation
of the acetabular component through the template for
subsequent reference.

A C E TA B U L A R E X P O S U R E A N D R E A M I N G

Complete exposure of the acetabulum is necessary to

ensure a satisfactory surgical result. Resect the
acetabular labrum circumferentially in order to
define the landmarks of the bony acetabulum. Clean
soft tissue or osteophytes from the acetabular fovea in
order to define the limits of the medial wall.
Surrounding soft tissues must be protected by retrac-
tion during the reaming process to avoid injury to crit-
ical structures.
Restoration of normal anatomy is an important prin-
ciple of reconstructive hip surgery. The acetabulum
must be medialized to restore the normal center of
Figure 1
the hip rotation as determined by preoperative
templating.
Ream the acetabulum concentrically in order to
ensure an excellent fit between the acetabulum and
the acetabular component (Figure 1). Do not reverse
the reamer direction during the reaming process.

Acetabular
Reamer Dome

Acetabular Reamer Handle

3
 To avoid excessive medial reaming of the acetabulum,
ream only until the last row of reamer fenestrations
is just contained within the acetabulum as over-
medialization could occur. Only Reflection (or hemi-
spherical) reamers should be used for Reflection
acetabular components.
Direct the reamer along the same axis as that desired
for the final position of the acetabular prosthesis.
This is generally in a position of approximately 45˚
of abduction and 20˚ to 30˚ of forward flexion.
Preserve subchondral bone to provide good support
for the prosthesis. Clean the acetabulum of all
remaining cartilage and soft tissue down to bleeding
subchondral bone.
The posterior and anterior walls (columns) of the
acetabulum must be considered while reaming, since
they are the limiting factor in determining the largest
size prosthesis that can be accommodated. Frequently
palpate these structures during the reaming process
to determine the maximum reamer size that should
be used.
To assess the fit and stability of the prepared acetabu-
lum, use the trial shell. Visualize through the slots in
the trial to determine the trial/bone contact. Note the
relationship of the trial to the surrounding bony land- Figure 2
marks; this will aid in determining the position for
inserting the acetabular shell (Figure 2).

Trial Shell

Trial Shell Handle

4
 Make sure the acetabular shell will be contained as
completely as possible without exposing the porous
coating. If the position is not correct, further ream
the acetabulum as necessary. An intraoperative X-ray
may help evaluate the position and remaining bone
stock of the acetabulum.
For press-fit of a porous-coated prosthesis, it is best to
under-ream the acetabulum by 1 to 2 mm. The qual-
ity of bone stock should determine whether under-
reaming is appropriate. Subchondral bone should be
preserved whenever possible.

A C E TA B U L A R S H E L L I N S E RT I O N

Select the appropriate acetabular implant. Attach the

selected prosthesis to the cup positioner/impactor and
insert it into the acetabulum.
The positioner references 45˚ of abduction and 20˚ of
forward flexion. Position the X-bar so that the verti-
cal bar is perpendicular to the long axis of the body
and the appropriate crossbar aligns with the long
axis of the body (Figure 3). Firmly impact the
inserter with a mallet. Assess the stability and contact
of the prosthesis by pushing on the rim of the device
with a femoral head pusher or a similar instrument.
No motion should be apparent during the evaluation,
Figure 3
indicating excellent press-fit of the prosthesis.

X-Bar

Cup Positioner/Impactor

5
 U S E O F S C R E W S F O R A D J U N C T I V E F I X AT I O N

The following sections on adjunctive fixation refer

to Reflection V only. Adjunctive fixation is not
available for Reflection I.
Generally, cancellous screws will provide satisfactory
adjunctive fixation. Four drill bits of progressively
increasing length are available.

CANCELLOUS SCREW OPTIONS

Screw Length Drill Length Drill Cat. No.
15 mm 15 mm 7136-2115
20 mm, 25 mm 25 mm 7136-2125
30 mm, 35 mm 35 mm 7136-2135 Figure 4
40 mm, 50 mm 50 mm 7136-2150

When positioning screw fixation holes, keep in mind

that the best quality bone for fixation screw holes is
in the superior, medial (weight bearing) region of the
acetabulum. The ischium and pubis will provide less
satisfactory engagement of screw threads. Take care,
when positioning and drilling holes, to avoid pene-
tration of the inner cortex of the pelvis, penetration
of the sciatic notch, or damage to vital neurovascular
structures. Do not place a screw in the center
hole of the acetabular prosthesis.
Placement of drills and screws in the anterior or
medial portions of the prosthesis is associated with a
high risk of potentially fatal vascular injury.
To predrill each screw hole, first seat the screw
drill guide fully through the correct hole in the
acetabular shell (Figure 4). The drill guide will
position the screw properly, avoiding impingement of
the screw head against the shell.
Drill each screw hole, taking care to not drill directly Screw Drill
medially or directly anteriorly. When screws are to be
placed in the direction of the sciatic notch, palpate
the notch so that injury to the sciatic nerve can be Screw Drill Guide
avoided.

ADJUNCTIVE FIXATION AVAILABLE FOR REFLECTION V ONLY.

6
 Before inserting the screws, use the depth gauge to
verify the appropriate screw length(s) (Figure 5).
This will help avoid penetration of the screws
through the inner table of the pelvis.
Use the screw holding forceps or the universal screw-
driver to hold the screw. Flex the tip of the universal
screwdriver in an upward position to hold the screw.
Introduce the screw into the hole and screw it into
place (Figure 6). Make sure the screw is fully seated
within the screw hole so that it will not impinge on
the acetabular shell liner. An inner diameter feeler
gauge is provided to determine if the screw is fully
Figure 5
seated (Figure 7).
Reassess stability of the prosthesis by pushing on it
and noting any motion. No motion should be
observed. If instability is noted, consider inserting the
next larger prosthesis or using cement fixation.

Angled Depth Gauge

Curved Screw Forceps

Figure 6

Ratchet Screwdriver Handle

Flexible Screwdriver Shaft

Universal Screwdriver Shaft

Feeler Gauge
Figure 7

ADJUNCTIVE FIXATION AVAILABLE FOR REFLECTION V ONLY.

7
 U S E O F P E G S F O R A D J U N C T I V E F I X AT I O N

Modular taper lock pegs can also be used to assist in When using pegs, the selected holes must be predrilled
stabilization of the acetabular prosthesis. The modu- with the 15 mm peg drill and peg drill guide. Drill
lar taper lock peg is available in a 15 mm length each peg hole, taking care not to drill directly medi-
with a blunt tip. A 15 mm drill bit and a peg drill ally or directly anteriorly. Verify the depth of the
guide are available for preparation of the peg holes. drilled hole with the angled depth gauge. When pegs
are placed in the direction of the sciatic notch, pal-
When positioning peg holes, keep in mind that the
pate the notch so that injury to the sciatic nerve can
best quality bone for pegs is in the superior, medial
be avoided. Do not place a peg in the threaded
(weight bearing) region of the acetabulum. The
center hole of the acetabular prosthesis.
ischium and pubis will provide less satisfactory sta-
bility. Take care, when positioning and drilling peg Before inserting the peg, inspect hole depth using
holes, to avoid penetration of the sciatic notch, or depth gauge and use pulsatile lavage and suction to
damage to vital neurovascular structures. clean the peg holes. All bone debris must be cleaned
from the peg holes to ensure proper taper lock
between the peg and hole taper.

Peg Drill Straight Peg Impactor

Angled Peg Impactor

Peg Drill Guide

ADJUNCTIVE FIXATION AVAILABLE FOR REFLECTION V ONLY.

8
 When inserting two or more pegs, insert all pegs into
the shell by hand and then impact with the peg
impactor and three moderate blows of a mallet
(Figure 8). Inspect the inner surface of the shell for
peg seating. An inner diameter feeler gauge is pro-
vided to determine if the peg is fully seated (Figure
9). If the peg is not flush with the inner diameter of
the shell, impact the peg again.
Reassess stability of the prosthesis by pushing the rim
of the shell and noting any motion. No motion should
be observed. If instability is noted, consider inserting
the next larger prosthesis or using cement fixation.
Figure 8

Peg Removal Technique

To remove a threaded peg, thread a disposable peg
removal pin into the peg by hand until it stops. Place
the peg removal instrument over the head of the
removal pin (Figure 10). Squeeze (close) the han-
dles of the peg removal tool to remove the peg. Use a
new peg removal pin for each peg.

Figure 9

Peg Removal Pin

Peg Removal Tool

Figure 10

ADJUNCTIVE FIXATION AVAILABLE FOR REFLECTION V ONLY.

9
 USE OF HOLE COVERS FOR CLOSURE

Once the shell is stable, tapered and/or threaded hole

covers can be used to close any unused holes. Before
inserting the tapered or threaded hole cover, use pul-
satile lavage and suction to clean the holes. All bone
debris must be cleaned from the holes to ensure
proper locking between the hole cover and the shell.

Tapered Hole Covers

Tapered hole covers can only be used with Reflection
V in the holes designed to accommodate pegs or
screws. Do not place a tapered hole cover in the
threaded apex hole. Use the disposable taper hole Figure 11
cover inserter to place the cover in the hole (Figure
11). Push the tapered hole cover straight into the
screw hole with the inserter, then lever the inserter
out of the hole cover.
After placing the tapered cover in the hole, position
the peg impactor in the tapered hole cover dimple
and impact with three moderate blows of a mallet.
Inspect the inner surface of the shell for cover seat-
ing. An inner diameter feeler gauge is provided to
determine if the cover is fully seated. If the tapered
hole cover is not flush with the inner diameter of the
shell, impact it again.

Threaded Hole Covers Figure 12

Threaded hole covers can be used with the Reflection I

and V shell in the center apex hole. Insert the threaded
hole cover into the center hole using the Reflection
screwdriver (Figure 12). Tighten the threaded hole
cover until it stops. Remove the screwdriver and use
the inner diameter feeler gauge to determine if the
threaded hole cover is fully seated (Figure 13). If the
threaded hole cover is not flush with the inner diame-
ter of the shell, the screwdriver should be reinserted
and the hole cover should be tightened further.

Tapered Hole Cover Inserter Figure 13

10
 A C E TA B U L A R L I N E R I N S E RT I O N

With the acetabular shell firmly positioned, place the

appropriate trial liner into the acetabular shell and
perform a trial reduction. Insertion of the trial liner
may help assess possible tissue impingement at the
locking mechanism. (Alternatively, the permanent
acetabular liner may be inserted at this time.)

POLYETHYLENE THICKNESS
A C E TA B U L A R C U P S I Z E
Femoral
Head Size 42 44 46-48 50-52 54-56 58-60 62-64 66-68 70
22 mm 6 7 8 10 12 13 15 17 19
26 mm NA 5 6 8 10 11 13 15 17
28 mm NA NA 5 7 9 10 12 14 16
32 mm NA NA NA 5 7 8 10 12 14

Socket liners are available with internal diameters of

22 mm, 26 mm, 28 mm, and 32 mm, with or without
20˚ rim extensions. The surgeon should select a
femoral head size to maximize polyethylene thick-
ness, i.e., small femoral heads should be used for
small acetabular prostheses. Position the extension to
optimize the stability of the reconstruction (generally
in the superior/ posterior position).
Before inserting the acetabular shell liner, the rim
and interior of the acetabular shell should be care-
fully cleaned of any remaining soft tissue or bone
debris. Then insert the liner, keeping the extension (if
used) in the same position determined during the
trial reduction. During liner insertion, make sure
soft tissue does not interfere with the
shell/liner interface. For liner impaction, place the
appropriate liner impactor head on the end of the
cup positioner/impactor. Prior to impacting the liner,
ensure the splines on the liner are aligned with the
splines of the shell.

Liner
Impactor
Head
Cup Positioner/Impactor

Trial Liner Liner Removal Tool

11
 The Reflection MicroStable liner
requires an impaction force between
120 and 200 pounds at room tempera-
ture. The required impaction force
increases with the diameter of the shell.
Chilling the liner reduces the impaction force
required to seat the liner. To ease liner insertion, chill
the liner in refrigerated or iced saline for a minimum
of five minutes. Chilling the liner is recommended
for all liners, especially liners 58 mm and larger.
Impact the liner until it is fully seated in the shell
(Figure 14). It is important to hold the impactor
perpendicular to the face of the cup while Figure 14
impacting the liner. Inspect to make sure the liner
is properly seated.
If removal of the liner is necessary, place the end
of the acetabular liner removal tool into the slot in
the rim of the acetabular shell until it engages the
liner and the liner disengages from the shell. If the
liner has not been damaged, it may be reinserted
one time only.

12
 C ATA L O G
A C E TA B U L A R C O M P O N E N T S

Reflection I and Reflection V

Shells and Liners

I N F O R M AT I O N
Reflection I Reflection V
Shell Shell O.D. Liner Liner I.D.
Cat. No. Cat. No. (mm) Size (mm)
74-3042 — 42 B 22
74-3044 74-0044 44 C 22, 26
74-3046 74-0046 46 D 22, 26, 28
74-3048 74-0048 48 D 22, 26, 28
74-3050 74-0050 50 E 22, 26, 28, 32
74-3052 74-0052 52 E 22, 26, 28, 32
74-3054 74-0054 54 F 22, 26, 28, 32
74-3056 74-0056 56 F 22, 26, 28, 32
74-3058 74-0058 58 G 22, 26, 28, 32
74-3060 74-0060 60 G 22, 26, 28, 32
74-3062 74-0062 62 H 22, 26, 28, 32
74-3064 74-0064 64 H 22, 26, 28, 32
74-3066 74-0066 66 J 22, 26, 28, 32
74-3068 74-0068 68 J 22, 26, 28, 32
74-3070 74-0070 70 K 22, 26, 28, 32

Reflection Acetabular Liners

0º Liner 20º Liner I.D. Liner
Cat. No. Cat. No. (mm) Size
7174-2042 7174-2242 22 B
7174-2044 7174-2244 22 C
7174-2046 7174-2246 22 D
7174-2050 7174-2250 22 E
7174-2054 7174-2254 22 F
7174-2058 7174-2258 22 G
7174-2062 7174-2262 22 H
7174-2066 7174-2266 22 J
7174-2070 7174-2270 22 K
7174-0644 7174-2644 26 C
7174-0646 7174-2646 26 D
7174-0650 7174-2650 26 E
7174-0654 7174-2654 26 F
7174-0658 7174-2658 26 G
7174-0662 7174-2662 26 H
7174-0666 7174-2666 26 J
7174-0670 7174-2670 26 K
7174-0846 7174-2846 28 D
7174-0850 7174-2850 28 E
7174-0854 7174-2854 28 F
7174-0858 7174-2858 28 G
7174-0862 7174-2862 28 H
7174-0866 7174-2866 28 J
7174-0870 7174-2870 28 K
7174-0250 7174-3250 32 E
7174-0254 7174-3254 32 F
7174-0258 7174-3258 32 G
7174-0262 7174-3262 32 H
7174-0266 7174-3266 32 J
7174-0270 7174-3270 32 K

13
I N F O R M AT I O N

Universal Acetabular Cancellous Screws

6.5 mm
Cat. No. Length
7133-6515 15 mm
7133-6520 20 mm
7133-6525 25 mm
C ATA L O G

7133-6530 30 mm
7133-6535 35 mm
7133-6540 40 mm
7133-6550 50 mm

Reflection Acetabular Fixation Peg

15 mm Length
Cat. No. 74-6615

Reflection Hole Covers

Cat. No. Description
74-6560 Tapered
7133-6500 Threaded

14
 C ATA L O G
A C E TA B U L A R T R I A L S

Reflection Trial Acetabular Shells

Cat. No. O.D. Cat. No. O.D.

I N F O R M AT I O N
73-0040 40 mm 73-0059 59 mm
73-0041 41 mm 73-0060 60 mm
73-0042 42 mm 73-0061 61 mm
73-0043 43 mm 73-0062 62 mm
73-0044 44 mm 73-0063 63 mm
73-0045 45 mm 73-0064 64 mm
73-0046 46 mm 73-0065 65 mm
73-0047 47 mm 73-0066 66 mm
73-0048 48 mm 73-0067 67 mm
73-0049 49 mm 73-0068 68 mm
73-0050 50 mm 73-0069 69 mm
73-0051 51 mm 73-0070 70 mm
73-0052 52 mm
73-0053 53 mm
73-0054 54 mm
73-0055 55 mm
73-0056 56 mm
73-0057 57 mm
73-0058 58 mm

Reflection Trial Acetabular Liners

0º 20º Liner
Cat. No. Cat. No. I.D. Size
7136-2042 73-2242 22 mm B
7136-2044 73-2244 22 mm C
7136-2046 73-2246 22 mm D
7136-2050 73-2250 22 mm E
7136-2054 73-2254 22 mm F
7136-2058 73-2258 22 mm G
7136-2062 73-2262 22 mm H
7136-2066 73-2266 22 mm J
7136-2070 73-2270 22 mm K
7136-0644 73-2644 26 mm C
7136-0646 73-2646 26 mm D
7136-0650 73-2650 26 mm E
7136-0654 73-2654 26 mm F
7136-0658 73-2658 26 mm G
7136-0662 73-2662 26 mm H
7136-0666 73-2666 26 mm J
7136-0670 73-2670 26 mm K
7136-0846 73-2846 28 mm D
7136-0850 73-2850 28 mm E
7136-0854 73-2854 28 mm F
7136-0858 73-2858 28 mm G
7136-0862 73-2862 28 mm H
7136-0866 73-2866 28 mm J
7136-0870 73-2870 28 mm K
7136-0250 73-3250 32 mm E
7136-0254 73-3254 32 mm F
7136-0258 73-3258 32 mm G
7136-0262 73-3262 32 mm H
7136-0266 73-3266 32 mm J
7136-0270 73-3270 32 mm K

15
I N F O R M AT I O N

A C E TA B U L A R C O M P O N E N T I N S T R U M E N TAT I O N

Acetabular Reamer Handle

38 mm–70 mm
Cat. No. 11-4265

Acetabular Trial Liner Handle (Optional)

C ATA L O G

Cat. No. Size

41-7519 22 mm
41-7518 26 mm
41-7517 28 mm
41-7505 32 mm

Acetabular Reamer Domes

Cat. No. Size Cat. No. Size
41-7138 38 mm 41-7158 58 mm
41-7139 39 mm 41-7159 59 mm
41-7140 40 mm 41-7160 60 mm
41-7141 41 mm 41-7161 61 mm
41-7142 42 mm 41-7162 62 mm
41-7143 43 mm 41-7163 63 mm
41-7144 44 mm 41-7164 64 mm
41-7145 45 mm 41-7165 65 mm
41-7146 46 mm 41-7166 66 mm
41-7147 47 mm 41-7167 67 mm
41-7148 48 mm 41-7168 68 mm
41-7149 49 mm 41-7169 69 mm
41-7150 50 mm 41-7170 70 mm
41-7151 51 mm
41-7152 52 mm
41-7153 53 mm
41-7154 54 mm
41-7155 55 mm
41-7156 56 mm
41-7157 57 mm

Acetabular Liner Extractor

Cat. No. 73-2107

Angled Depth Gauge

Cat. No. 73-2109

Acetabular Cup Screwdriver

Ratchet Handle
Cat. No. 73-2112

Acetabular Cup Universal Screwdriver Shaft

Cat. No. 73-2113

Acetabular Cup Flexible Screwdriver Shaft

Cat. No. 73-2114

16
 C ATA L O G
R E F L E C T I O N I & V

Tapered Hole Cover Inserter

I N F O R M AT I O N
Cat. No. 73-2133

Acetabular Screw Drills

Cat. No. Length
7136-2115 15 mm
7136-2125 25 mm
7136-2135 35 mm
7136-2150 50 mm

Acetabular Screw Drill Guide

Cat. No. 7136-2101

Acetabular Peg Drill Guide

Cat. No. 7136-2102

Acetabular Straight Peg Impactor

Cat. No. 73-2116

Acetabular Angled Peg Impactor

Cat. No. 73-2117

Peg Drill
15 mm Length
Cat. No. 7136-2118

Trial Handle
Cat. No. 73-2119

Acetabular Cup Positioner/Impactor

Cat. No. 73-2120

Reflection Curved Screw Forceps

Cat. No. Bend
73-2136 35º
73-2137 75º

17
I N F O R M AT I O N

T-Handle Hex Wrench

Cat. No. 21-0009
C ATA L O G

X-Bar
Cat. No. MT-2201

Acetabular Cup I.D. Feeler Gauge

Cat. No. 73-2121

Acetabular Cup Liner Impactor Heads

Cat. No. Size
73-2122 22 mm
73-2126 26 mm
73-2128 28 mm
73-2132 32 mm

Peg Removal Tool

Cat. No. 73-2127

Peg Removal Pin

Cat. No. 73-2129

18
 C ATA L O G
A C E TA B U L A R T R AY S

I N F O R M AT I O N
Primary Instrument Tray
Cat. No. 73-1000

Trial Acetabular Liner Tray

Cat. No. 73-1001

Trial Acetabular Liner Tray Insert

Cat. No. 73-1002

Trial Acetabular Shell Tray

Cat. No. 73-1003

Reamer Dome Tray

38 mm - 70 mm
Cat. No. 73-1004

19
 IMPORTANT MEDICAL INFORMATION
Warnings and Precautions
POROUS COATED TOTAL HIP SYSTEM
IMPORTANT NOTE Zirconium Zirconia Head Contraindications may be relative or absolute and must
Alloy Heads Ceramic Heads Diameter Neck Length be carefully weighed against the patient’s entire evalua-
Total hip replacement arthroplasty has become a suc- — 42-7814 32 mm Short –3 mm tion and the prognosis for possible alternative proce-
cessful procedure in relieving pain and restoring motion 7138-3200 42-7815 32 mm Standard 0 mm dures such as nonoperative treatment, arthrodesis,
in patients who are disabled from hip arthropathy. 7138-3204 42-7816 32 mm Long 4 mm femoral osteotomy, pelvic osteotomy, resection arthro-
The goals of total hip replacement are to decrease pain, 7138-3208 42-7817 32 mm X-Long 8 mm plasty, hemiarthroplasty, and others.
increase function, and increase mobility. To accomplish 7138-2800 42-7818 28 mm Standard 0 mm Conditions presenting increased risk of failure include:
these goals, patients should be selected who: 7138-2804 42-7819 28 mm Long 4 mm osteoporosis; metabolic disorders which may impair
7138-2808 42-7820 28 mm X-Long 8 mm bone formation; and osteomalacia.
1. have and are expected to maintain adequate bone 7138-2604 — 26 mm Long 4 mm
support; 7138-2608 — 26 mm X-Long 8 mm Possible Adverse Effects
2. are anatomically able to accept the size prosthesis 22 mm heads are available for the small taper femoral 1. Wear of polyethylene articulating surfaces of acetab-
commensurate with their activity and load require- components and are impacted directly on the femoral ular components has been reported following total
component. Heads are highly polished for reduced fric- hip replacement. Higher rates of wear may be initiat-
ments; and
tion and wear. Clean and dry stem taper prior to impact- ed by particles of cement, metal, or other debris
3. are able and willing to follow their physician’s direc- ing the femoral head or taper sleeve. which can cause abrasion of the articulating sur-
tions generally, and particularly with respect to no or faces. Higher rates of wear may shorten the useful
minimal weight bearing postoperative care. The modular femoral head component must be firmly life of the prosthesis, and lead to early revision
seated on the femoral component to prevent dissocia- surgery to replace the worn prosthetic components.
Insert the largest stem feasible (especially in large tion. Modular heads and femoral components should be
patients). Patients should be cautioned against any 2. With all joint replacements, asymptomatic, local-
from the same manufacturer to prevent mismatch of ized progressive bone resorption (osteolysis) may
heavy labor, active sports, or any activity which places tapers. Scratching of modular heads and tapers should occur around the prosthetic components as a con-
heavy or abrupt loads on implanted prostheses. be avoided. Repeated assembly and disassembly of the sequence of foreign body reaction particulate mat-
DESCRIPTION OF SYSTEM head/neck component to the femoral stem could com- ter. Particulates are generated by interaction
promise a critical locking action of the taper socket joint. between components, as well as between the com-
The Porous Coated Total Hip System consists of The head/neck component should be changed only ponents and bone, primarily through wear mecha-
femoral components, proximal pads, taper sleeves, dis- when clinically necessary. Do not resterilize femoral nisms of adhesion, abrasion, and fatigue.
tal sleeves, acetabular shells and liners, fixation screws prostheses with ceramic heads seated on the stem. Secondarily, particulates can also be generated by
and pegs, and hole covers. The porous coated products Acetabular Components third-body wear. Osteolysis can lead to future com-
promote biological ingrowth. All implantable devices are plications necessitating the removal and replace-
for single use. Acetabular components are two-piece implants consist- ment of prosthetic components. See Important
ing of a titanium shell and a polyethylene liner. Physician Information Section for more
Materials Cancellous screws may be inserted through the screw information.
Femoral components, proximal pads, taper sleeves, dis- holes in the shell to aid in cup fixation. Tapered pegs
may also be used with Reflection V shells to provide 3. Loosening, bending, cracking, or fracture of the
tal sleeves, acetabular shells, fixation screws and pegs, prosthetic components.
adjunctive fixation when desired. Tapered hole covers
and hole covers are Titanium 6 Aluminum 4 Vandium
are available for Reflection V shells. Threaded hole cov- 4. Dislocations, subluxation, decreased range of
Alloy (ISO 5832/3). The femoral components, proximal ers are available for Reflection I and V shells. motion, or lengthening or shortening of the femur,
pads, porous coated distal sleeves, and acetabular caused by improper neck selection, positioning,
shells have a coating of commercially pure (C.P.) Femoral Components, Universal Heads, Zirconia
looseness of acetabular or femoral components or
titanium beads (ASTM F 67 and ISO 5832/2). Ceramic Heads, and Zirconium Alloy Heads are
extraneous bone; also penetration of the femoral
designed for use with any Smith & Nephew Richards prosthesis through shaft of femur, fracture of the
Acetabular liners are manufactured from UHMWPE UHMW polyethylene acetabular component or UHMW acetabulum, especially with prior hip surgery,
(ASTM F 684). polyethylene-lined, metal backed acetabular component and/or excessive reaming.
The specific component material is provided on the out- having an appropriately sized inside diameter.
5. Fracture of the pelvis or femur. Postoperative
side carton labels of the components. INDICATIONS, CONTRAINDICATIONS, AND pelvic fractures are usually stress fractures.
ADVERSE EFFECTS Femoral fractures are often caused by defects in
Some of the alloys needed to produce orthopaedic
implants contain some metallic components that may be General the femoral cortex due to prior screw holes, misdi-
carcinogenic in tissue cultures or intact organisms under rected reaming, etc. Intraoperative fractures are
The general principles of patient selection and sound usually associated with old congenital deformity,
very unique circumstances. Questions have been raised surgical judgment apply. The specific components cho- improper stem selection, improper broaching, and
in the scientific literature as to whether or not these sen will be largely dependent on the patient’s age, gen- severe osteoporosis.
alloys may be carcinogenic in implant recipients. eral condition, condition of available bone stock, any
Studies conducted to evaluate this issue have not iden- prior surgery, and anticipated further surgeries. 6. Infection, both acute postoperative wound infec-
tified convincing evidence of such phenomenon, in spite Prosthetic replacement is generally indicated only for tions and late deep wound sepsis.
of the millions of implants in use. patients who have reached skeletal maturity. 7. Neuropathies: femoral, sciatic, peroneal nerve, and
Indications lateral femoral cutaneous neuropathies have been
Femoral Components reported.
Femoral components are available in a variety of sizes to Porous Coated Total Hips Systems are indicated for
uncemented use in skeletally mature individuals under- 8. Wound hematoma, thromboembolic disease
provide a snug fit in the intramedullary canal. Femoral including venous thrombosis, pulmonary embolus
going primary surgery for rehabilitating hips damaged
components are porous coated proximally for biological or myocardial infarction.
as a result of trauma or noninflammatory degenerative
ingrowth. Modular stems also accept a porous coated joint disease (NIDJD) or any of its composite diagnoses 9. Tissue reactions: lysis, macrophage and particles
distal sleeve for distal biological growth. Femoral com- of osteoarthritis, avascular necrosis, traumatic arthritis, and foreign body reaction adjacent to implants,
ponents are available in either a small or large taper. The slipped capital epiphysis, fused hip, fracture of the resulting from foreign material in tissues. Also,
large tapers are machined to mate and lock with either pelvis, and diastrophic variant. myositis ossificans, especially in males with hyper-
26, 28, or 32 mm metal or ceramic heads. The large trophic arthritis, limited preoperative range of
Some of the diagnoses listed above and below may also motion and/or previous myositis.
taper femoral components may also be used with bipolar
increase the chance of complications and reduce the
components or unipolar heads. The small tapers mate chance of a satisfactory result. 10. Trochanteric nonunion: usually associated with
directly with a 22 mm metal head and with a taper sleeve early weight bearing and/or improper fixation of the
which in turn mates with either 26, 28, or 32 mm metal or Contraindications trochanter, when a transtrochanteric surgical
ceramic heads, bipolars, or unipolars. 1. Conditions that would eliminate or tend to eliminate approach is used.
Taper Sleeves adequate implant support or prevent the use of an 11. Intrapelvic protrusion of acetabular component.
appropriate size implant, e.g.:
A taper sleeve is required to be impacted on the small 12. Although rare, metal sensitivity reactions in
a. blood supply limitations; patients following joint replacement have been
taper femoral components prior to impacting femoral
heads of 26, 28, or 32 mm. A taper sleeve is required to b. insufficient quantity or quality of bone support; reported. Implantation of foreign material in tissues
can result in histological reactions involving
attach a unipolar head. Unipolar taper sleeves are avail- c. infections or other conditions which lead to macrophages and fibroblasts.
able in both small and large tapers. Never place more increased bone resorption.
than one taper sleeve on a femoral component. 13. Fatigue fracture of the implant can occur as a result
2. Mental or neurological conditions which tend to of trauma, strenuous activity, improper alignment,
Femoral Heads impair the patient’s ability or willingness to restrict or duration of service. Implants can loosen or
activities, especially during the healing period, e.g., migrate due to trauma or loss of fixation.
Cobalt Chromium and Zirconium alloy heads and drug use, mental illness, senility, and other neuro-
ceramic heads are available in a variety of diameters logic conditions. 14. Damage to blood vessels.
and neck lengths for proper anatomic and musculature 15. Temporary or permanent nerve damage resulting
fit. The following Zirconium Alloy Metal Heads and 3. Physical conditions or activities which tend to place
extreme loads on implants, e.g., Charcot joints, in pain or numbness of the affected limb.
Zirconia Ceramic Heads are available for use with 16. Traumatic arthrosis of the knee from intraoperative
muscle deficiencies, multiple joint disabilities, etc.
porous coated femoral components: positioning of the extremity.
4. Skeletal immaturity.
 17. Delayed wound healing. tates precise operative technique and the use of 4. Postoperative therapy should be structured to
18. Aggravated problems of the affected limb or con- specified instruments. Intraoperative fracture of the regain muscle strength around the hip and a grad-
tralateral extremity caused by leg discrepancy, femur can occur during seating of the prosthesis. ual increase of activities.
excess femoral medialization, or muscle deficiency. Bone stock must be adequate to support the 5. Periodic X-rays are recommended for close com-
device. parison with immediate postop conditions to detect
19. Periarticular calcification or ossification, with or
without impediment to joint mobility. 8. If titanium screws or tapered pegs are used for long-term evidence of changes in position, loosen-
supplemental fixation of the acetabular component, ing, bending, and/or cracking of components or
20. Inadequate range of motion due to improper selec- use caution while drilling holes and inserting the cement or bone loss. With evidence of these con-
tion or positioning of components, by femoral bone screws or tapered pegs to avoid vessels, ditions, patients should be closely observed, the
impingement, and periarticular calcification. nerves, and visceral structures. A drill guide is rec- possibilities of further deterioration evaluated, and
WARNINGS AND PRECAUTIONS ommended for drilling holes and a depth gauge the benefits of early revision considered.
should be used to determine the proper length of 6. Prophylactic antibiotics should be recommended to
Loosening, bending, cracking, and/or fracture of bone screws. Clean holes with lavage and suction
implants and other complications may result from failure the patient similar to those suggested by the
prior to inserting screws or pegs. Perforation of the American Heart Association for conditions or situa-
to observe the following warnings and precautions. pelvis with dome fixation screws or rim screws is to
The patient should be warned of surgical risks, and tions that may result in bacteremia.
be completely avoided. Care is to be used when
made aware of possible adverse effects. The patient determining and selecting the proper length of 7. Failure of the porous coating substrate interface
should be warned that the device does not replace nor- screws used. Perforation of the pelvis with screws may result in bead separation or delamination.
mal, healthy bone, and that the implant can break or that are too long can rupture blood vessels causing IMPORTANT PHYSICIAN INFORMATION
become damaged as a result of strenuous activity or the patient to hemorrhage. ONLY USE REFLEC-
trauma, and has a finite expected service life and may TION TITANIUM BONE SCREWS, TAPERED Bone resorption is a natural consequence of total joint
need to be replaced in the future. Refer to the surgical PEGS, AND HOLE COVERS with the Reflection arthroplasty due to changes in bone remodeling pat-
technique for additional warnings and precautions. Acetabular Component and ONLY USE OPTI-FIX® terns. Bone remodeling is mediated by the changes in
TITANIUM BONE SCREWS with the Opti-Fix stress distribution caused by implantation. Extensive
Preoperative resorption around the prosthesis leads to implant loos-
Acetabular Component. Bone screws must be
1. Use extreme care in handling and storage of completely seated in the holes of the shell to allow ening and failure. Progressive bone resorption due to
implant components. Cutting, bending, or scratch- proper locking for the acetabular component liner. reasons other than stress shielding or infection has
ing the surface of components can significantly The threaded center hole in Reflection shells does been termed osteolysis. It is generally agreed that oste-
reduce the strength, fatigue resistance, and/or not accept screws or pegs, but it does accept the olysis is the result of localized foreign body reaction to
wear characteristics of the implant system. These, threaded hole cover. The Reflection FSO only particulate debris generated by cement, metal,
in turn, may induce internal stresses that are not accepts cancellous Universal Screws, not pegs or UHMWPE, and ceramic. Regarding the etiology, it had
obvious to the eye and may lead to the fracture of hole covers. Tapered pegs can only be used with been hypothesized that particulate debris generated by
the component. Implants and instruments should Reflection V shells. the components of a prosthesis migrate into the synovial
be protected during storage from corrosive envi- cavity and the bone implant interface, where they recruit
ronments such as salt air. Do not allow the porous 9. If the tapered pegs need to be removed from the macrophages and stimulate phagocytic action. The
surfaces to come in contact with cloth or other fiber shell after impaction of the pegs, do not reuse the degree of recruitment is determined by the size, distrib-
releasing materials. pegs or the peg shell holes. Use new pegs and dif- ution, and amount of particulate debris (rate of debris
2. An adequate inventory of implant sizes should be ferent shell holes. generation). The phagocytic action results in the release
available at the time of the surgery, including sizes 10. With the congenitally dislocated hip, care should of cytokines and intercellular mediators (IL-1, 2, PE2)
larger and smaller than those expected to be used. be taken to prevent sciatic nerve palsy. Also note which encourages osteoclastic bone resorption. Clinical
Extra implant components are recommended. All that the femoral canal is often very small and and basic research is continuing in order to provide sci-
packages and implants should be thoroughly straight and may require an extra-small straight entific basis for the causes of this phenomenon and
inspected prior to surgery for possible damage. femoral prosthesis; however, a regular sized pros- potential ways to reduce its occurrence.
3. Patient conditions and/or predispositions such as thesis should be used when possible. Note that the Osteolysis can be asymptomatic and therefore routine
addressed in Contraindications, above, should be true acetabulum is rudimentary and shallow. A periodic radiographic examination is vital to prevent any
avoided. false acetabulum should not ordinarily be utilized serious future complication. Presence of focal lesions
as a cup placement site for anatomical and biome- which are progressive may necessitate replacement of
4. Allergies and other reactions to device materials, chanical reasons.
although infrequent, should be considered, tested the prosthetic component(s).
for (if appropriate), and ruled out preoperatively. 11. If components are to be left in place at revision PACKAGING AND LABELING
surgery, they should first be thoroughly checked for
5. Surgical Technique brochures, available on signs of looseness, cement condition, etc., and Implants should be accepted only if received by the hos-
request at no charge, should be reviewed by the replaced if necessary. pital or surgeon with the factory packaging and labeling
surgeon prior to initial surgery. intact. If the sterile barrier has been broken, refer to the
12. Care should be taken not to scratch, bend, or cut Resterilization section below.
6. Intraoperative fracture or breaking of instruments metal components during surgery for the reasons
can occur. Instruments which have experienced stated in Number One of the Preoperative Section STERILIZATION
extensive use or excessive force are susceptible to of Warnings and Precautions, above. The compo- All metal components are provided sterile and have
fracture. Instruments should be examined for wear nent should be firmly seated with the component been sterilized by a minimum of 25 kilo Grays of gamma
or damage prior to surgery. insertion instruments. irradiation. Plastic components have been sterilized by
Intraoperative 13. Once removed from the patient, implants previ- ethylene oxide gas. All components are supplied in pro-
1. The correct selection of the implant is extremely ously implanted should never be reused, since tective trays. Inspect packages for punctures or other
important. The appropriate type and size should be internal stresses which are not visible may lead to damage prior to surgery.
weighed against anatomical and biomechanical early bending or fracture of the components. RESTERILIZATION
factors such as patient age and activity levels, 14. Prior to closure, the surgical site should be thor-
weight, bone and muscle conditions, and others; Metal Components
oughly cleaned of bone chips, extraneous cement,
generally, the largest cross-section components Metal components may be resterilized, if necessary, by
etc. Ectopic bone and/or bone spurs may lead to
which will allow adequate cement and/or bone sup- steam autoclaving in appropriate protective wrapping,
dislocation or painful or restricted motion. Range of
port to be maintained is preferred. Failure to use after removal of all the original packaging and labeling.
the optimum size components may result in loos- motion should be thoroughly checked for early con-
tact or instability. Malpositioning of either the Protect prosthesis, particularly mating surfaces, from con-
ening, bending, cracking, or fracture of the compo- tact with metal or other hard objects. The following
nents, cement, and/or bone. femoral or acetabular component can result in
instability and dislocation. process parameters are recommended for these devices:
2. Correct selection of the neck length and cup, and Prevacuum cycle, 4 minutes at 132O C to 135O C, followed
stem positioning, are important. Muscle looseness 15. Small taper stems sizes 8S–12L must have a min- by 20 minutes of drying time.
and/or malpositioning of components may result in imum neck length of +8 when used with a bipolar
If porous coated implants are inadvertently contaminated,
subluxation, dislocation, and/or fracture of compo- component; and small taper stem sizes 12S–16L
return the unsoiled prosthesis to Richards for resteriliza-
nents. Increased neck length and varus positioning must have a minimum neck length of +4 when
tion. DO NOT RESTERILIZE porous coated implants. The
will increase stresses which must be borne by the used with a bipolar component.
porous coating requires special cleaning procedures.
stem. Postoperative
Plastic Components
3. Prior to seating the liner component into the shell 1. Postoperative directions and warnings to patients
of modular acetabular components, surgical debris Plastic components may be resterilized by ethylene
by physicians, and patient care, are extremely
must be cleaned from the interior of the shell. oxide gas, using the following procedures:
important. Gradual weight bearing is begun after
Debris may inhibit the liner from locking into the surgery in ordinary total hip arthroplasty. However, Sterilant Temperature Humidity Maximum Concentration Exposure
shell component. Failure to properly seat the liner with trochanteric osteotomy or certain complex Pressure Time
into the shell can lead to dissociation of the liner cases, weight bearing status should be individual- 88% Freon 130 C
O
90–100% 21 psia 550–650 mg/L 105 minutes
from the shell. ized with the non or partial weight bearing period 12% EtO or 40–60%
4. A +12 mm XX-long or longer femoral head extended. 100OC 50% 21 psia 650 mg/L 6 hours
should not be used with any of the small taper 2. Patients should be warned against unassisted
stems. Suggested aeration time is 12 hours at 50 C with power
O
activity, particularly use of toilet facilities and other
aeration. Consult aerator manufacturer for more specific
5. Distal sleeves should not be used to bridge activities requiring excessive motion of the hip.
instructions.
cortical defects that lie within 25 mm of the tip 3. Use extreme care in patient handling. Support
of the base stem. INFORMATION
should be provided to the operative leg when mov-
6. 32 mm heads with a –3 mm neck length are not ing the patient. While placing the patient on bed- For further information, please contact Customer
available for use with the small taper stems. pans, changing dressings, clothing, and similar Service at 1-800-238-7538.
activities, precautions should be taken to avoid
7. Tight fixation at the time of surgery is critical to the placing excessive load on the operative part of the
success of the procedure. The femoral component body.
stem must press fit into the femur, which necessi-

3433446 CAUTION: (U.S.A.) Federal law restricts this device to sale by or on the order of a physician. 3/95
 Smith & Nephew, Inc. • 1450 Brooks Road • Memphis, TN 38116 U.S.A.
(901) 396-2121 • For information: 1-800-821-5700 • For orders and order inquiries: 1-800-238-7538

Reflection, MicroStable, ExtrusionLock, and Opti-Fix are trademarks of Smith & Nephew, Inc. U.S. Patent Numbers 5,226,917 and 5,310,408.
©1996 Smith & Nephew, Inc. 7/95 7138-0127