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JFAPBC (2004) 3:17-23 ASM International

DOI: 10.1361/15477020419794 1547-7029 / $19.00

O R TH O P E D I C S by B. Aksakal, .S.Yildirim, and H. Gul

Metallurgical Failure Analysis of Various Implant


Materials Used in Orthopedic Applications

Failure is one of the most


important aspects of implant
materials behavior and directly
influences the choice of materials
and production methods in
manufacturing.

Introduction
This study investigated implants
made of titanium alloy Ti6Al4V and
316L steel that were obtained from
revision operations between 1993 and
2002. The operations were required
because of various types of implant
failures. This paper illustrates nine
cases of metallurgical failures of a total
hip prosthesis, femoral compression
plates, femoral nail plates, spinal rods,
vertebral implants, and intramedullar
nails fabricated from stainless steel
and titanium alloy. The most common
causes of the implant failures eval-
uated were stress-corrosion fatigue
and wear. The other contributing
factors for the implant failures were
production errors, existence of
inclusions, stress gaps from manu- implant failure analysis is a complex provides information for improve-
facturing routes, and loosening of area of study. Despite the care taken ments in design, operating procedures,
implant material from bone due to in their design, installation, operation, and the use of components. The
lack of osseointegration. and machining, components fail. causes of failure of implant com-
Failure is one of the most impor- Although only a small fraction of im- ponents can be broken down into
tant aspects of implant materials plants fail, failure is a common occur- several categories: misuse; assembly or
behavior and directly influences the ence because of the large number of implantation errors; design errors,
choice of materials and production implants; thus, failure analysis re- including improper selection of
methods in manufacturing. Because mains an extremely important sub- materials; corrosion; corrosion fatigue;
of the many variables involved, ject. Establishing the causes of failure and wear.

Journal of Failure Analysis and Prevention Volume 4(3) June 2004 17


Metallurgical Failure Analysis of Various Implant Materials (continued)

According to statistical data, ap- processes. The implants are coated for and showed that manufacturing de-
proximately 100 million metallic better wear, with osseointegration fects and the use of nonstandard
implants were installed in humans plasma spray, sol-gel dipping, electro- materials led to failure. Implant
between 1940 and 1975.[1] The most chemical, electrophoretic, and sput- failure of a nail was investigated
important markets for medical pro- tering methods commonly used as metallurgically, and it was shown that
ducts are the United States, where surface treatments. [4-13] The full fatigue zones around distal locking
annual revenues are approximately success of an implant depends on vari- holes and screws were predominant
$62 billion, the European Union, ous factors, such as proper indication in the failure process. [20] Edwin et
with revenue of $40 billion, and of the case, surgical techniques and al.[21] showed that closed exchange
Japan, where the revenues are approx- equipment, patient rehabilitation, nailing with fibulectomy was a
imately $20 billion.[2] biocompatibility, as well as manufac- reasonable option for treatment when
Biomedical materials must not turing routes, mechanical properties, the initial nails supporting a tibial
damage the body, must sustain mini- biological stabilization, and the sur- fracture failed.
mal damage from the body, and must rounding environment. Wear and corrosion of the counter-
provide the required strength, espec- parts in sliding hip screwplates pro-
ially high fatigue strength and tough-
Selected Cases duce debris. Corrosion changes the
ness, for joints and other applications. from the Literature chemical environment around the
The essence of a biomaterial is an Gilbert et al.[14] investigated two implant, inducing an acidic pH[22]
economic (cheap) implant with the modular hip implants with a cobalt- and thus increasing the likelihood of
mechanical, physical, and chemical alloy head and a
properties that provide structural cobalt-alloy stem Corrosion changes the chemical environment
capability without deleterious effects after a fracture around the implant, inducing an acidic pH and
on the body. Metallic materials such occurred in the neck thus increasing the likelihood of corrosion.
as stainless steel, 316L, cobalt- region of the femoral
chromium alloys, and pure titanium component. It was
and its alloys have been used for sur- concluded that the fracture occurred corrosion. Surgically removed stainless
gical implant materials. The +-type due to intergranular corrosive attack steel sliding hip screwplates have
titanium alloy, such as Ti6Al4V, has and cyclic fatigue loading of the stem. shown significant wear, corrosion, and
been most widely used as an implant A numerical method (finite element) damage to the surrounding tissue.[23]
material for artificial hip joints and was developed by Chaodi et al. to Similar work with implant alloys
dental implants due to its high predict the progressive failure of a such as titanium and 316L steel[24-
26]
strength and excellent corrosion resis- thick, laminated composite femoral has supported these observations.
tance. Pure titanium and other +- component for total hip arthroplasty Additionally, Toshikazu and Mit-
type titanium alloys were originally under in vivo loading conditions.[15] suo[27] showed a relationship between
designed for use as general structural fatigue damage and mechanical
Jaffe and Scott[16] considered the
materials, especially for aerospace properties in Ti6Al4V alloy.
relationship between fatigue and
structures, but have also been adapted A review work by McGee et al.[28]
hydroxyapatite coating thickness.
for biomedical applications. The showed that early loosening is related
Lynn and DuQuesney [17] showed
development of titanium alloys espec- to poor initial fixation and design,
that residual stress generated during
ially intended to be used in living and that late loosening of a joint
plasma spray coating helps to initiate
bodies began with the introduction replacement is related to wear of the
cracks and enhance crack propagation.
of new alloys using biocompatible [18] prosthetic components. Berger et
Howie et al. showed the biological
stabilizer elements, such as iron, al. [29] showed another failure case
effects of cobalt-chromium in animal
tantalum, zirconium, tin, and occurring due to dissolution of hy-
cells and pointed out that in vitro and
niobium.[3] droxyapatite of coated implants.
in vivo findings should be compared
The manufacturing of implant with the results from human studies. These selected studies illustrate the
materials generally requires advanced Akoy et al.[19] also investigated a frac- number of variables involved in the
casting and/or continuous forging tured partial Thompson prosthesis implant failure process. However, it

18 Volume 4(3) June 2004 Journal of Failure Analysis and Prevention


is important to note that most im- removed the failed materials, they cases were due to lack of osseointe-
plants are successfully used and that were investigated metallurgically gration.[1,2] Many failures occur be-
although there are numerous failures, through a scanning electron micro- cause of bad design, misuses, improper
failure is a relatively rare event. scope (SEM). The type of implant production, and nonstandard com-
materials, their survival time in the positions and/or mechanical proper-
Materials and Methods body, their chemical composition, and ties, for example, the implant fails to
The experimental procedures used the reasons for failure are summarized fulfill the requirements of an Inter-
to investigate the failures reported in Table 1. The analysis showed that national Organization for Standard-
here include visual inspection and the reasons for implant failures were ization (ISO) standard.
both macroscopic and microscopic corrosive attack, improper manufac- Metal fatigue has been studied
characterization. The materials turing, and fatigue. extensively, and the fatigue strengths
studied in this work were six implants of common metallic implant alloys
that were extirpated from revision Results and Discussion used in orthopedic applications, such
patients. None of the patients had Surgical implants are exposed to as stainless steel, cobalt, and titanium
septic symptoms. These implants aggressive working conditions in alloys, and their relations to their
were located in patients for an average terms of corrosion, wear, and mech- microstructure, surface, and corrosion
time period of 2 to 3 years (minimum, anical loading (static and dynamic). properties have also been reported.[32-
6 months; maximum, 7 years). The The possibility of premature failure 34]
Despite numerous investigations,
application time together with the exists, and such failures are influenced the occurrence of such failures is still
causes of failure are summarized in by factors such as materials selection, a major problem. A variety of micro-
Table 1. manufacturing practice, medical graphic features were observed on the
installation procedure, postoperative fractured or mechanially damaged
Failed implant materials removed
complications, and patient mis- surfaces and through microscopic
from patients undergoing coxarthrosis
use.[30,31] The systematic investigation indications. These features include
and scoliosis revision operations were
of retrieved surgical implants in- intergranular/transgranular cracking,
the core of the investigations. A total
creases the knowledge regarding fatigue striations, and cleavage or
hip prosthesis was implanted in 1993,
clinical implant performance, demon- cleavagelike surface topography.
and after 7 years, a fracture occurred
strates interactions between implants
in the femoral stem. In three other Several implant failure cases that
and the body, provides a basis for the
cases, fractures occurred in less than occurred in the authors patients over
development of biocompatible im-
2 years. Observations showed that for a 9 year period are shown in Fig. 1.
plant materials, encourages design
nearly all fracture cases, improper Between 1993 and 2002, 37 osteo-
optimization, and assists medical
osseointegration accelerated the synthesis reimplantations were made;
device research.
implant failure. In a case of implanta- in six of the cases, the implant
tion due to scoliosis, a spinal rod fail- Statistical analysis shows that 5 to loosened due to biological wear, and
ure occurred 3 years after the opera- 10% of the 6.2 million implants crack three of the cases were due to infec-
tion. After the revision operations while in service and that many of the tion. A total hip prosthesis was
Table 1 Type of Implant Material, Chemical Composition, Survival Time
in Body, and Reasons for Failure

Type of Implant Composition Survival Time, yr Failure Reason


Total hip prosthesis 17Cr-14Ni 7 Inclusions, shrinkage cavities,
segregations
Intramedullar nails 15Cr-10Ni-15Nb 1.5 Wear, fatigue
Spinal rods 17Cr-15Ni-3Mn 3 Corrosive attack, pitting, wear
Compression plates Ti-6Al-4V 1 Inclusions,
multiorigined ductile fracture
Vertebral implant 316L 2 Erosion-corrosion, stress corrosion Fig. 1 Several implant failures that occurred
Femoral nail plate 316L 2.5 Wear, fatigue, stress corrosion in the authors patients

Journal of Failure Analysis and Prevention Volume 4(3) June 2004 19


Metallurgical Failure Analysis of Various Implant Materials (continued)

replaced because of pain. After re- Figure 2(a) shows a fractured spinal The SEM micrograph in Fig. 3
moving the prosthesis, it was seen that rod postoperated from a 2-year-old shows that the fracture surface that
the implant was broken at the stem. boy due to thoracal scoliosis. Figure caused the failure is due to a combined
Segregation, inclusions, and micro- 2(b) is an intramedullar nail osteo- effect of inclusions and perhaps a
constituents are aligned and elongated synthesis femur diaphyseal fracture shrinkage cavity from casting. Intra-
in directions determined by the metal failure postoperated from a 2-year- medullar rods failed in the body and
flow, resulting in mechanical fibering. old boy. A plate (jewet) osteosynthesis were replaced. After microstructural
Centerline segregation in the ingot and subtrochanteric fracture failure examination, it was determined that
caused center cracks in forging oper- postoperated from a 3-year-old boy failure occurred due to low fatigue
ations, and this acted as a stress con- is shown in Fig. 2(c), while Fig. 2(d) strength. The SEM fractograph in
centrator or crack initiator. shows a postoperated osteosynthesis Fig. 4 shows striation lines and secon-
Radiographs of some of the failed femur diaphyseal fracture failure from dary fatigue cracks. In addition, a
implants are shown in Fig. 2(a-d). a 2-year-old boy. fretting effect also took place, and this
is an indication of wear assisted by
selective attack. Figure 5 shows an
intergranular fracture surface with a
triple point at the grain juncture due
to stress corrosion. For hexagonal
close-packed metals, the dislocation
structure and cyclic behavior are more
sensitive to crystal orientation than
are cubic metals because their aniso-
tropic properties produce diverse
microfractographic features.[35-37]
Figure 6 shows the fracture surfaces
of a vertebral implant made of 316L,
where stress corrosion caused brit-
tleness and resulted in brittle fracture.
Some of the factors that cause stress
corrosion are misalloying, aggressive
body environment, and residual
stresses. The latter caused this type
of failure. In nearly all prosthetic
devices, and particularly those having
multicomponents, the regions of stress
concentration often coincide with
crevice areas, where localized corro-
sion is more likely. [32] The adverse
effects of implant-derived wear par-
ticles on periprosthetic tissues are also
important in bone loss and loosening
of implant prostheses. Early loosening
is related to poor initial fixation and
design; late loosening, which is the
major problem and principal cause of
failure, is related to wear of the pros-
Fig. 2 Radiographs of failed implants. (a) Spinal rod failure. (b) Intramedullar nail fracture and thetic components.[28]
osteosynthesis failure. (c) Subtrochanteric plate (jewet) fracture failure. (d) Femur diaphyseal
fracture failure of a compression plate The conjoint degradation processes

20 Volume 4(3) June 2004 Journal of Failure Analysis and Prevention


of corrosion and wear of metal sur- 13Zr and highest for Ti6Al4V.[24] spinal hollow rod was removed from
faces is clearly of great importance in The clinical consequences of at least another patient. Through SEM
the design of orthopedic prostheses. partially corroding implants are well observations, it was seen that a typical
In a situation in which corrosion and known. The release of solutes, that is, pitting-type failure occurred due to
wear are both possible degradation corrosion products, at an implant site corrosive attack, which originated the
mechanisms, each could have a pro- may cause histological changes in the fracture from inside the hollow rod,
found effect on the other. However, local tissue by either direct toxic as shown in Fig. 8.
overall degradation when both corro- effects or a local hypersensitivity reac- The failure during use of a titanium
sion and wear processes are occurring tion, because elemental nickel, cobalt, reconstruction plate for osteosynthesis
is shown to be lowest for Ti-13Nb- and chrome as well as their com- was investigated through SEM, and
pounds are known allergens.[25] In Fig. the fractured surfaces are shown in
7, a typical surface resulting from Fig. 9(a-c). From the micrographs, it
erosion-corrosion damage is seen. A can be observed that the crack ori-
ginated from inclusions (Fig. 9a),
appears mainly in brittle regions (Fig.
9b), and resulted in multiorigined
ductile fracture with dimples (Fig.

Fig. 3 Scanning electron micrograph showing


combined effect of inclusions and
shrinkage cavity during casting
Fig. 6 Scanning electron micrograph of stress
corrosion

Fig. 4 Scanning electron micrograph showing


fatigue striations and secondary fatigue
cracks Fig. 7 Typical surface resulting from erosion-
corrosion damage c

Fig. 9 (a) The crack originated from


Fig. 5 Intergranular fracture surface showing inclusions. (b) The crack propogated
a triple point at the grain juncture due Fig. 8 Pitting-type failure occurred due to and resulted in multiorigined style.
to stress corrosion corrosive attack (c) Ductile fracture with dimples

Journal of Failure Analysis and Prevention Volume 4(3) June 2004 21


Metallurgical Failure Analysis of Various Implant Materials (continued)

9c). Selective attack and intergranular The study revealed that the failure Failure Modes in Orthopaedic Implants,
cracking on the external surface of the of the stainless steel femoral com- Proc. Int. Symp. on Retrieval and Analysis
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cluded that implant failures most and unidirectional bending. Evans, and S. Radin: Effect of Calcium
Phosphate Coating Characteristics on
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which a high amount of plastic sion fatigue promoted by the pres- 40.
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composition and manufacturing pro- The failure of hollow spinal rods
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