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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.
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
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
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
of Orthopaedic Implants, NBS special publ.
plate occur mainly near the fracture pression plates occurred by a 472, National Bureau of Standards, MD,
origin (Fig. 10). fretting-fatigue mechanism under 1976, pp. 11-21.
From the analysis, it can be con- the action of low nominal stresses 6. P. Ducheyne, J. Beight, J. Cuckler, B.
cluded that implant failures most and unidirectional bending. Evans, and S. Radin: Effect of Calcium
Phosphate Coating Characteristics on
often result in ductile fracture forms The failure of femoral compression
Early Post-Operative Bone Tissue
due to excessive dynamic loading in titanium plates occurred by corro- Ingrowth, Biomaterials, 1990, 11, pp. 531-
which a high amount of plastic sion fatigue promoted by the pres- 40.
energy is absorbed. Inadequate im- ence of intense localized corrosion 7. S. Ban and S. Maruno: Effect of Temp-
plant material as well as nonstandard and intergranular cracking. erature on Electrochemical Deposition of
composition and manufacturing pro- The failure of hollow spinal rods
Calcium Phosphate Coatings in a Simu-
cesses, improper design and heat lated Body Fluid, Biomaterials, 1995, 16,
occurred by overload caused by the pp. 977-81.
treatment, and faulty coating meth- intense formation of pitting corro-
ods are the main reasons for failure. 8. J.A. Jansen, J.G. Wolke, S. Swann, J.P.
sion during service. The pitting was Van der Waerden, and K. deGroot:
associated with the presence of Application of Magnetron Sputtering for
Conclusions superficial manufacturing routes. Producing Ceramic Coatings on Implant
Through metallurgical SEM anal- Materials, Clin. Oral Implants Res., 1993,
ysis, it was found that 42% of failures As a result of the analysis of various 4, pp. 28-34.
occurred due to corrosion plus ero- implant materials, the main reasons 9. C.S. Kim and P. Ducheyne: Compo-
sion-corrosion, 16.5% were due to in- for failure are corrosive attack, manu- sitional Variations in the Surface and Inter-
clusions and stress gaps that could be facturing defects, and nonstandard- face of Calcium Phosphate Ceramic
caused failures. Biocompatible Coatings on Ti and Ti-6Al-4V due to
correlated to fatigue, 16.5% had traces Sintering and Immersion, Biomaterials,
of production impurities, and 25% inorganic materials, such as hydroxy- 1991, 12, pp. 461-69.
showed fatigue via ductile-type fail- apatite coating with some binders,
10. P. Cheang and K.A. Khor: Addressing
ures. The results/reasons correlation would make the dissolution of metal Processing Problems Associated with Plas-
can be summarized as follows: ions difficult and so may delay corro- ma Spraying of Hydroxyapatite Coatings,
sion and wear and also minimize the Biomaterials, 1996, 17, pp. 537-44.
In the investigation of a total hip loosening of implants from bone. 11. C.P.A.T. Klein, J.G.C. Wolke, J.M.A. de
prosthesis, the fracture was multi- Blieck-Hogervorst, and K. deGroot:
origined, probably due to the pres- References Features of Calcium Phosphate Plasma-
ence of manufacturing defects in 1. G.K Smith and J. Black: Models for Sprayed Coatings: An In Vitro Study, J.
both surfaces of the device; was Systemic Effects of Metallic Implants, Biomed. Mater. Res., 1994, 28, pp. 961-
Proc. Int. Symp. on Retrieval and Analysis 67.
associated with poor design of the
of Orthopaedic Implants, NBS special publ. 12. K. Ishikawa, M. Kon, S. Tenshin, and N.
component; and introduced points 472, National Bureau of Standards, MD, Kuwayama: Effect of Preparation Condi-
of high stress concentration. 1976, pp. 23-30. tions in Aqueous Solution on Properties
2. C.R.F. Azevedo and E. Hippert, Jr.: of Hydroxyapatite, Dent. Mater., 1990, 9,
Failure Analysis of Surgical Implants in pp. 58-69.
Brazil, J. Eng. Failure Analys., 2002, 9, 13. P. Ducheyne, W. Van Raemdonck, J.C.
pp. 621-33. Heughebaert, and M. Heughebaert:
3. C.R.F. Azevedo: Failure Analysis of a Structural Analysis of Hydroxyapatite
Commercially Pure Titanium Plate for Coatings on Titanium, Biomaterials, 1986,
Osteosynthesis, J. Eng. Failure Analys., 7, pp. 97-103.
2003, 10, in press. 14. J.L. Gilbert, C.A.Buckley, et al.: Inter-
4. G. Pitrowski: Clinical Biomedics, Proc. granular Corrosion-Fatigue Failure of
Int. Symp. on Retrieval and Analysis of Cobalt-Alloy Femoral Stems, J. Bone
Orthopaedic Implants, NBS special publ. Joint Surg. Am., 1994, 76(1), pp.110-15.
Fig. 10 Intergranular cracking by selective 472, National Bureau of Standards, MD, 15. L. Chaodi, G. Christopher, et al.: Pro-
attack on the external surface of the 1976, pp. 41-49. gressive Failure Analysis of Laminated
plate near the fracture origin 5. D.F. Williams: A Review of Metallurgical Composite Femoral Prostheses for Total