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Pseudotumors in Total
Joint Arthroplasty
Johannes Michiel van der Abstract
Merwe, MBChB, FRCSC » The true incidence of pseudotumors in association with total joint
arthroplasty is underestimated.

» Pseudotumors occur with metal-on-metal, metal-on-polyethylene,

Investigation performed at the
and metal-on-ceramic articulations.
University of Saskatchewan,
Saskatoon, Saskatchewan, Canada
» Metal ion levels should not be the only factor in decision-making
regarding revision surgery.

» Revision surgery is only indicated in symptomatic patients with

clinical and radiographic findings and elevated metal ion levels.

» Revision to a non-metal articulation is strongly suggested.

P
seudotumors can present as any
mass (cystic or solid) that is in
continuity with a prosthetic
joint and cannot be attributed
to an infection, a malignancy, a bursa,
or scar tissue1,2. Other terms that are
commonly used to describe a pseudotu-
mor are aseptic lymphocyte-dominated
vasculitis-associated lesion (ALVAL), bur-
sae, and adverse reactions to metal debris
(ARMD)3. Pseudotumors are present
in metal-on-metal (MoM), metal-on-
polyethylene (MoP), and metal-on-
ceramic (MoC) articulations4. The recent
randomized controlled trial by Bisseling
et al. demonstrated pseudotumors in all 3 of
the aforementioned groups. However,
there were more solid lesions in MoM
articulations; the other types of articula-
tions were associated more with bulging
periprosthetic fluid collections4.
ARMD is an umbrella term that
encompasses metallosis, ALVALs, and
pseudotumors (Fig 1). Metallosis is the
abnormal macroscopic staining of soft tis-
sues and is associated with abnormal wear5
(Figs. 2-A and 2-B). ALVAL is a histological
diagnosis and describes unique cellular
changes that occur periprosthetically in
response to metal particles6.
Incidence
The incidence of pseudotumors ranges
from 1% to 4% in patients who underwent
MoM hip arthroplasties7-9. The true inci-
dence is most likely underestimated due to
undiagnosed pseudotumors in asymptom-
atic patients. Women have a greater inci-
dence (9.4%) compared with men (0.5%).
The incidence of pseudotumors is also
thought to increase with time since the
arthroplasty8. Higher incidences have been
reported (as high as 39% in the study by
Bosker et al.2), possibly because of routine
screening protocols for asymptomatic
patients. In May 2011, the U.S. Food and
Drug Administration (FDA) ordered the
postmarket surveillance of MoM hip
replacement systems10. Unfortunately,
there is also a downside to routine screen-
ing: it can lead to the identification of
lesions in otherwise asymptomatic patients,
which might cause a higher rate of revision
in patients with lesions that might have
remained asymptomatic. Routine screen-
ing also can lead to increased costs to the

COPYRIGHT © 2021 BY THE Disclosure: The author indicated that no external funding was received for any aspect of this work.
JOURNAL OF BONE AND JOINT The Disclosure of Potential Conflicts of Interest form is provided with the online version of the
SURGERY, INCORPORATED article (http://links.lww.com/JBJSREV/A680).

JBJS REVIEWS 2021;9(4):e20.00125 · http://dx.doi.org/10.2106/JBJS.RVW.20.00125 1

 | P s e u d o t u m o r s i n To t a l J o i n t A r t h r o p l a s t y

Fig. 1
ARMD is the umbrella term that encompasses
the histological, radiographic, and intraoper-
ative findings. ARMD 5 adverse reactions to
metal debris, and ALVAL 5 aseptic
lymphocyte-dominated vasculitis-associated
lesion.

health system and unnecessary emo-
tional distress for patients.
Currently, at my institution, we are
performing routine screening for all
patients who received an MoM hip
arthroplasty. This involves a thorough
physical examination and history taking.
Diagnostic investigations are not insti-
tuted until patients become sympto-
matic or have localized findings.
Routine screening is not the only
reason that can explain the increased
incidence of asymptomatic pseudotu-
mors. Other reasons include
manufacturing, surgeon, and patient
factors. Manufacturing factors include
shorter and smaller femoral necks and
tapers, which reduce flexural rigidity.
Surgeon factors include the use of larger
femoral heads to increase stability, the
mismatching of components, and poor
assembly force. Patient factors include
the increase in obesity rates that is seen in
most populations as well as increased
activity levels after implantation. All of
these factors do contribute to larger
forces being applied at the head-neck
junction, which can lead to corrosion11.
Etiology
There is no clear consensus regarding the
etiology of pseudotumors, but current
theories vary between cellular toxicity
from excessive wear debris in poorly
aligned components to an abnormal
reaction to moderate wear debris and
hypersensitivity to metal. Particle size,
type, and volume differ between a well-
functioning MoM implant and a poorly
positioned implant. Malpositioned
components tend to have higher volu-
metric wear, with larger particles sizes
and higher cobalt (Co) content12.
The Co particles and ions are
responsible for cell toxicity. It is well
accepted that blood metal ion levels are
related to wear3. The release of metal
ions in solution from Co nanoparticles

Fig. 2-A Fig. 2-B

Figs. 2-A and 2-B Substantial corrosion following catastrophic failure of a total hip arthroplasty.

2 APRIL 2021 · VOLUME 9, ISSUE 4 · e 20.00125


in greater numbers compared with
chromium (Cr) nanoparticles could
explain why Co is more cytotoxic. In
contrast, Kwon et al. concluded that it is
the Co nanoparticles that cause the
cytotoxicity rather than the Co ions13.
Individual biologic response to these
nanoparticles varies and, therefore, if a
susceptible patient is exposed to an ele-
vated concentration of nanoparticles
that is higher than the individual’s
threshold, the formation of pseudotu-
mors can occur.
Histology
There is conflicting evidence that pseu-
dotumors and pseudotumor-like lesions
are caused by a reaction to high wear (in
large-head MoM articulations) or are a
type-IV metal hypersensitivity reaction
(in trunnionosis or small-head MoM
articulations). Histological features
of ALVAL have also been described in
non-MoM bearing surfaces and dem-
onstrate a physiological response to
metal wear debris. This can occur to
some degree in all implanted metal
femoral components14,15. Gill et al.3
found that the common histological
findings in failed MoM prostheses are
likely due to a cytotoxic reaction, a de-
layed hypersensitivity reaction (type-IV
hypersensitivity reaction), or a combi-
nation of both. For a type-IV hyper-
sensitivity reaction to occur, there needs
to be an antigen (metal particle), co-
stimulatory molecules, antigen-
presenting cells (macrophages), and
T lymphocytes. T lymphocytes and
macrophages produce cytokines
(interleukin-1 [IL-1], tumor necrosis
factor-a [TNF-a], IL-2, interferon
[IFN], and receptor activator of nuclear
factor kappa-B ligand [RANKL]). These
cytokines trigger an inflammatory reac-
tion that could lead to tissue destruction
and pseudotumor formation3,16. This is
in stark contrast with a type-II hyper-
sensitivity reaction (infection) where
neutrophil granulocytes are present in
each high-power field.
Campbell et al. studied the histol-
ogy of pseudotumor-like tissues in the
high-wear group and the group with
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metal hypersensitivity and concluded
that these lesions can occur in both
instances17. Metal hypersensitivity was
classified as patients having pain without
a clear reason (e.g., aseptic or septic
loosening, impingement) and pain res-
olution with component removal. They
found that the most extensive damage to
the surrounding tissues and the densest
lymphocyte aggregates occurred in
patients with metal hypersensitivity
with low wear.
Willert et al.6,14 described the his-
tological appearance of the peri-
prosthetic tissues as characteristic of
diffuse, perivascular, and intramural
infiltration of lymphocytes (ALVALs).
There was only a small amount of metal
wear debris noted in the tissues. They
postulated that the low but continued
release of metal ions leads to an immu-
nological response that causes prolif-
eration of sensitized T lymphocytes.
These cells express and release proin-
flammatory cytokines, which in turn
leads to endotheliosis and recruitment
and activation of monocytes and/or
macrophages. This could cause degra-
dation of the matrix and subsequent
osteolysis, with loosening of the
components.
However, there is variability in the
amount and distribution of metal debris.
As noted by Davis and Morrison, mac-
rophages and lymphocytes were present
in all of their cases, but large infiltrates of
macrophages (cases of high wear with
high concentrations of metal ions) ten-
ded to have smaller lymphocyte aggre-
gates and vice versa9. ARMD do cause
ulceration and destruction of the syno-
vial lining, but the degree of damage is
more extensive with low-wear metal ion
release (cases of metal hypersensitivity)9.
In an earlier article by Willert and
Semlitsch6, an “equilibrium state” was
described. They postulated that the
periprosthetic lymphatics can clear wear
debris that is generated by the joint
articulation. If the amount that is cleared
equals the generated amount, then an
“equilibrium state” is achieved. If more
debris is generated than can be cleared,
some of the wear debris will spill over
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into the effective joint space. They
concluded that certain patients will
therefore develop adverse tissue reac-
tions while others seem to have a mild or
no reaction.
Co-Cr-Mo (molybdenum) alloys
are resistant to corrosion due to a ther-
modynamically stable oxide layer that is
highly enriched in Cr18. When this layer
is damaged, Cr is rapidly transformed
into Cr oxide, while Co and Mo diffuse
from the metal. Particles produced at
this bearing surface can then either enter
the synovial fluid or the surrounding
tissues (Fig. 3). Intra-articular metal
particles are believed to cause synovial
ulceration with an increased infiltration
of lymphocytes in the subsynovial
layer19. This is a characteristic feature of
MoM bearings. Metal particles corrode,
releasing metal ions. In the synovial
fluid, the metal ions are released in large
volume, which is in contrast to the metal
particles in the surrounding tissues. This
is the reason why metal ions need higher
concentrations in the synovial fluid to
cause the same effect as metal ions in the
surrounding tissue20. There are theories
that propose that the CoCr particles are
phagocytosed by macrophages (Fig. 3).
Once phagocytosed, they corrode
quickly because of the acidic environ-
ment in the phagolysosome. This causes
a release of metal ions, which are toxic to
the macrophages. Lysis of the cells
occurs, releasing all of their contents,
with a subsequent vicious cycle of
necrosis21. This is in strict contrast to
polyethylene particles, which elicit a
foreign-body granulomatous-response-
simulating infection. Metals cannot be
eliminated from tissues by metabolic
degradation; they are eliminated only by
renal or gastrointestinal excretion22.
Metal particles and ions do not only
work locally; they can also cause damage
farther away from the affected joint
because of the concept of the “effective
joint space.” Nanoparticles have the
ability to disseminate systemically and
affect many organs, causing a variety of
symptoms (e.g., tinnitus, vertigo, deaf-
ness, blindness, convulsions, cardiomy-
opathy, and hypothyroidism)3.
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Risk Factors for ARMD
There are conflicting studies that dem-
onstrate and refute the argument that
the increased horizontal lever arm re-
sulting from a larger head size could lead
to increased taper wear rates in MoM
bearings that are $36 mm in size14,23.
Head-neck taper corrosion has been
associated more with the taper design
(taper cone angle, taper surface rough-
ness, and taper geometry), the alloy
combinations, and the length of
implantation14. A reduced “arc of cover”
in the acetabular cup design is known to
result in inadequate head coverage,
which leads to poor fluid film lubrica-
tion and subsequent edge-loading with
high wear rates23. Edge-loading is also
increased with high cup inclination
angles (.50°) and insufficient version
angles23.
Other risk factors include in-
creased activity levels, serum Co levels
of .5 mg/L, metallurgy, component
modularity, allergies to metal, and
4 APRIL 2021
tapered femoral-neck damage that can
occur from frictional torque at the
bearing surface. Women tend to have a
higher incidence of pseudotumors.
Bone size and native anatomy (dysplasia
that can lead to cup malpositioning) are
thought to be the main factors for this
finding2,23. Obesity did not influence
blood Co and Cr levels, but low body
mass index (BMI) has been proposed as a
potential risk factor.
Trunnionosis
Modular components and cone tapers
create 2 potential interfaces for me-
chanically assisted corrosion (Figs. 2-A
and 2-B). Corrosion has been demon-
strated in similar and dissimilar metal
alloys at the head-neck junction5. Cor-
rosion of the trunnion is secondary to
repeated cyclical loading. This can lead
to gross trunnion failure (GTF)24. GTF
is defined as considerable corrosion at
the head-neck junction that can be
visually appreciated and can lead to dis-
Fig. 3
The cyclical pathway by which metal particles
formed from MoM articulations lead to tissue
destruction and the eventual formation of
pseudotumors. The blue arrows indicate met-
allosis while the green pathway illustrates the
“hypersensitivity theory” (mainly seen in the
context of corrosion and wear at the modular
interfaces) and the orange pathway demon-
strates the “high-wear” theory. ALVAL 5
aseptic lymphocyte-dominated vasculitis-
associated lesion, and ARMD5 adverse reac-
tions to metal debris.
sociation of the head-neck interface12. It
has been postulated that trunnionosis is
more common in men and in patients
with an increased BMI12. Components
with tapers made of more flexible alloys
with a higher horizontal offset, larger
femoral heads, and a low neck angle are
all possible causes for increased corro-
sion. Trunnionosis is a consequence of 3
factors: taper and implant design, the
loading situation in each patient, and the
assembly by the surgeon11.
Diagnostic Tests
It is important to complete a thorough
workup (i.e., a detailed history and
physical examination). The physical
examination should include a systemic
review to identify signs and symptoms of
arthroprosthetic metallosis.
Serum markers (erythrocyte sedi-
mentation rate and C-reactive protein
level) are of limited value in diagnosing a
periprosthetic joint infection (PJI) with
MoM implants. The markers can be
· VOLUME 9, ISSUE 4 · e 20.00125

falsely elevated without an infection.
Therefore, it is more useful to rule out an
infection. Synovial fluid aspiration
should be performed manually because
inclusion of the metallic debris that is
present could otherwise lead to errors
due to contamination23. Newer PJI
detection methods (e.g., the leukocyte
esterase test, the alpha defensin test, and
the polymerase chain reaction [PCR]
test) may start to play a more important
role in diagnosing infection in these sit-
uations. Even though serum marker
analyses do have limitations, these tests
should be performed to determine the
patient’s baseline values.
Radiographs are mainly used for
component position assessment and
evaluation of osseous lesions. They are
not sensitive enough to evaluate cystic or
soft-tissue masses. The one exception is
the incipient failure of a flexible stem,
with the characteristic radiographic
finding of a slight oblique angle between
the femoral head and the neck taper and/
or a faint radiodensity around the hip
capsule, similar to heterotopic
ossification25.
The different modalities that are
used to screen for cystic or solid soft-
tissue masses are ultrasonography,
computed tomography (CT), and mag-
netic resonance imaging (MRI). Ultra-
sonography is a safe and easily available
method. It can assess for small lesions
close to the prosthesis where metal
scatter might make the use of CT and
MRI less appealing. It can distinguish
between cystic and solid masses and help
guide biopsy and aspiration. Ultraso-
nography is operator-dependent and,
therefore, some institutions do not use it
as a first-line screening modality2. There
is a propensity for low-grade cystic
pseudotumors to be nonprogressive in
asymptomatic patients and, therefore,
ultrasonography can be considered as a
modality of choice in these situations23.
CT is less operator-dependent and
more readily available compared with
metal artifact reduction sequence
(MARS) MRI. CT can be helpful in
patients who cannot undergo MRI9. It
might be useful to use iodinated contrast
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to localize and characterize periarticular
cystic pseudotumors. Comparing the
enhanced and unenhanced images is
necessary because one would expect a
paucity of actual enhancement for solid
lesions. Internal debris can mimic
enhancement if no unenhanced images
are available for comparison9.
MARS MRI can differentiate
equivocal cases that have been identified
on ultrasonography or CT and assist the
surgeon in preoperative planning. Other
advantages of MARS MRI are the
superiority in soft-tissue contrast and the
absence of ionizing radiation. There are
many different methods of reducing
metal artifacts. Unfortunately, they are
time-consuming and will reduce image
quality. There are classification systems
that have been developed for peri-
prosthetic soft-tissue masses that are
identified on MRI. They mainly dis-
tinguish between solid and cystic
lesions. Solid masses are usually associ-
ated with more severe symptoms, which
explains the higher revision rates for
patients with solid masses1. Cystic
lesions predominantly present posteri-
orly to the prosthesis, while solid lesions
are more likely found anteriorly.
Arthrography should not be used
routinely, but it is considered the most
accurate way of confirming communi-
cation between the cyst and the joint. If a
mass enhances with contrast when the
hip joint is injected, it favors a diagnosis
of pseudotumor over a malignant mass.
However, a lack of contrast filling a mass
after an intra-articular injection does not
rule out a pseudotumor9.
Metal ion concentrations are con-
sistently higher in patients with MoM
articulations compared with MoP and
MoC articulations3,26. With MoM
bearings, there is increased volumetric
wear between the 2 metal surfaces,
which subsequently leads to an increased
release of metallic products (particles
and ions).
Controversial evidence exists link-
ing high-wear MoM articulations with
increased necrosis and macrophage
infiltration25. Metal ion levels (serum
and/or whole blood, synovial) have not
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been shown to correlate with intra-
operative damage, the presence of
pseudotumors, the size of pseudotu-
mors, or the amount of wear debris in the
synovial fluid23.
Initial reference values for metal
ions were obtained by looking at
“exposure equivalents of carcinogenic
substances” for industrial workers as well
as the Mayo Medical Laboratories
Interpretive Handbook27. Co levels of 5
mg/L in whole blood and Cr levels of 17
mg/L in erythrocytes were determined as
reference values. Multiple studies sub-
sequently tried to establish acceptable
levels. Hart et al. demonstrated that Co
and Cr levels of 0.5 mg/L would not be
100% sensitive, and levels as high as 15
mg/L would only provide 98% speci-
ficity28. By using 7 mg/L (or 7 ppb), a
high specificity (Co, 93%; Cr, 94%) as
well as modest sensitivity (Co, 70%; Cr,
52%) can be obtained. By lowering the
threshold to $5 ppb, the sensitivity
decreased to 63% but the specificity
increased to 86%23. Metal ions have
been reported to decline to near-normal
levels within 3 months following revi-
sion to non-metal bearing surfaces23.
The Medicines and Healthcare products
Regulatory Agency (MHRA) adopted
these values. Mean Co levels in a well-
functioning MoM arthroplasty range
between 0.2 and 4.0 mg/L23.
Peak serum levels of Co and Cr
occurred at 6 to 12 months postopera-
tively, depending on femoral head size,
with large-diameter femoral heads
showing a peak in concentration at 6
months and smaller femoral heads
peaking at 12 months. This was thought
to be secondary to the “run-in phase.”
These peaks gradually declined over the
next 15 months16,27.
There are currently no interven-
tion thresholds for systemic Co toxicity,
but the majority of cases with systemic
adverse effects have Co levels of .100
mg/L23. Co toxicity is very rare; it has
been reported in patients who under-
went revision surgery for a failed
ceramic-on-ceramic (CoC) total hip
arthroplasty to an MoP articulation.
These patients can present with
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neurological damage, hypothyroidism,
and cardiomyopathy, which may not
resolve completely even after removal of
the prosthesis29.
Metal ions levels are an adjunct and
should never be used in isolation when
contemplating revision surgery. It is
important to do metal ion testing in
similar samples (serum and/or whole
blood) and in the same laboratory in
order to minimize variability among
results26.
Treatment
One of the main indications for the
revision of MoM articulations is when
patients become symptomatic and have
elevated metal ion levels. Symptoms
from pseudotumors emerge slowly and
initially are mild. These symptoms can
include groin pain, hip discomfort,
paresthesia, antalgic gait, and/or a pal-
pable mass. Arterial occlusion can pre-
sent with ischemic pain in the limb,
while an occluded vein may provoke
marked swelling of the extremity.
MARS MRI permits a confirmation of
the corresponding or concomitant
complications of pseudotumor forma-
tion. Pain is thought to be the strongest
predictor of pseudotumor presence.
Patients also often note a clicking or
clunking sensation in the hip, stiffness,
reduced range of motion, abductor
weakness, and even a rash.
Another reason for surgical inter-
vention is when an enlarging pseudotu-
mor demonstrates muscle necrosis. If a
patient’s symptoms become persistent,
unmanageable, and progressive and are
combined with radiographic findings
(e.g., implant loosening, pseudotumors)
or elevated metal ion levels, revision
surgery should be considered.
Willert et al. concluded that none
of their 5 patients who underwent revi-
sion to a second MoM articulation had
resolution of their symptoms14. The
symptoms only resolved after revision
without an all-metal bearing surface.
This suggests that an immunological
response persisted and that the patients
were sensitized to the debris of the MoM
articulation.
6 APRIL 2021
In my institution, during revision,
we debride all of the necrotic tissue
meticulously, taking care to protect the
neurovascular structures. This can be
thought of in the same way as an onco-
logical procedure where the surgeon aims
for clear margins to reduce the risk of
recurrence. The abnormal tissue from the
pseudotumor can be tenaciously adher-
ent to the adjacent vessels (femoral artery
and/or vein) or the neurological struc-
tures (sciatic, femoral, or lateral femoral
cutaneous nerves). The usefulness of
MARS MRI during surgical planning
might be hampered due to the proximity
of the artifactual features of the implants.
Proper exposure is crucial for the success
of the surgery. Surgeons should be ready
to perform multiple approaches to help in
removing the pseudotumor and protect-
ing the neurovascular structures. When
working in close proximity to the vessels,
a prudent course is collaboration with a
vascular surgeon. Patients should also be
informed about the potential risks that
are associated with removal of the
pseudotumor.
At my institution, during revision
surgery, we use a bearing surface with an
altogether different tribological pairing,
and we avoid all CoCr components. We
commonly use a ceramic femoral head
with a titanium sleeve that articulates
with a highly cross-linked polyethylene
liner. This is mainly to lessen the risk of
recurrence that is associated with trun-
nionosis. CoC articulations are another
option. Previous concerns with CoC
articulations (fracture and squeaking)
are becoming less of a problem with the
newer components. Periarticular infil-
tration of the pseudotumor can lead to
dehiscence of the thigh and gluteal
muscular compartments, which could
lead to instability with subsequent dis-
locations. If instability is determined
intraoperatively, we use a constrained
device (namely, a constrained tripolar
socket). Patients are not restricted in
their weight-bearing status postopera-
tively but are instructed to maintain hip
precautions for 3 months.
The risk of revision for an MoM
hip resurfacing that presents with a
pseudotumor has been quoted to be as
high as 70%30. Half of the patients who
underwent these revisions developed
major complications, and one-third
required additional revision, which was
thought to be due to the wear debris
remaining following the first revision.
After revision surgery, pseudotumor
recurrence was reported to be between
3% and 18%23. Overall pain and func-
tional status were poor and comparable
with their preoperative values. These
findings emphasized that patients
should undergo revision earlier before
substantial necrosis is present. In
patients who underwent early revision
without any signs of soft-tissue destruc-
tion, good results have been shown15.
The difficulty arises in distinguishing
the ideal patient and the ideal time for
surgical intervention.
The natural history of pseudotu-
mors is unknown; some short-term
studies have demonstrated that the
majority of cases of pseudotumor
increase in size. After revision surgery,
pseudotumors generally disappear.
Long-Term Effects
Pseudotumors can exert direct pressure
on adjacent structures. This can lead
to an array of complications, includ-
ing deep venous thrombosis, lower-
extremity edema, femoral and sciatic
nerve palsy, ureteral obstruction, and
vesicle compression9. Metal debris is of
particular concern because of its pro-
pensity to disseminate systemically.
Studies have shown potential genotox-
icity of metal ions and wear particles.
The long-term clinical consequences
of potential DNA and chromosomal
changes remain unknown, and, to
my knowledge, no studies have yet
to demonstrate clinically relevant
complications31,32. Some large cohort
studies did not show any increased risk
of cancer in patients with MoM hip
replacements at 4, 7, and 17 years of
follow-up26,33.
Nephrotoxicity becomes an im-
portant factor because the kidney elim-
inates most of the Co and the Cr. To my
knowledge, no studies thus far have
· VOLUME 9, ISSUE 4 · e 20.00125

demonstrated an association between
ion levels and renal markers in the short
or medium terms34.
One study investigated 3 patients
who had MoM hip resurfacing done prior
to becoming pregnant35. Umbilical cord
blood was obtained at delivery, and metal
ion levels were determined. Co and Cr
levels in the umbilical cord were 50% and
75% less compared with the plasma
concentrations in the mothers. All 3 of
the infants were healthy, but no long-
term follow-up was recorded.
Metal ions also have an effect on
certain bone cells. Co and Cr are toxic to
osteoblasts and mature and precursor
osteoclasts16. Multiple modalities have
been studied to treat systemic metal
toxicity (chelators, zinc dosing, and
hemodialysis), but without any evidence
to recommend them23.
Follow-up
Currently, the MHRA recommends
annual follow-up for the life of the hip
replacement in patients who underwent
MoM hip arthroplasties36. The FDA
recommends that asymptomatic
patients be screened periodically. This
should mainly involve a thorough
physical examination that should focus
on localized (i.e., swelling, masses, joint
dislocation and/or subluxation) and
systemic symptoms (i.e., cardiovascular,
neurological, renal, and thyroid). Rou-
tine radiographic and serological testing
should not be performed in asymptom-
atic patients. Patients who are at risk
should be identified and closely moni-
tored, including women and those with
small-femoral-head MoM articulations,
renal insufficiency, increased activity,
malpositioned components, and bilat-
eral implants37.
In symptomatic patients, the FDA
advises that there is insufficient evidence
to use metal ion levels in decision-
making regarding treatment and clinical
outcomes. The FDA recommends a
thorough clinical examination to deter-
mine systemic and local signs and
symptoms. Diagnostic imaging should
be considered as part of the evaluation.
The risks and benefits of each diagnostic
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modality should be taken into account
to determine the most appropriate test.
The Scientific Committee on
Emerging and Newly Identified Health
Risks has suggested that patients with
metal ion levels of .7 mg/L or patients
with levels between 2 and 7 mg/L with
clinical and radiographic concerns
should be monitored more closely with
repeat testing and regular follow-up26.
There are no consistent guidelines
regarding monitoring; therefore,
screening of patients should be
individualized.
Medicolegal Implications
Medicolegal implications can result
when a symptomatic patient has a failed
implant following arthroplasty. Sur-
geons should practice careful clinical
appraisal, good clinical and surgical
judgment, and good surgeon-patient
relationships, and they should keep well-
documented records38. Routine sur-
veillance of recalled components should
occur; patients should be counseled that
revision in an asymptomatic patient
with a recalled implant cannot be justi-
fied without objective findings.
Overview
Pseudotumors can result in a substantial
increase in health-care costs and emo-
tional distress for both patients and
physicians. Patients who are at risk
should be closely monitored. Currently,
there is no evidence suggesting carcino-
genesis and teratogenesis in humans
with MoM hip replacements. At my
institution, we evaluate at-risk patients
annually with a thorough physical
examination. Imaging is only utilized if a
patient becomes symptomatic. Metal
ion levels are used in conjunction with
the clinical and radiographic findings
and are not the only factor in decision-
making regarding revision surgery. If
patients are symptomatic or have
alarming findings on imaging, we plan
revision surgery using components that
do not contain CoCr.
Johannes Michiel van der Merwe, MBChB,
FRCSC1
|
1Adult Reconstruction, Orthopaedic
Department, University of Saskatchewan,
Saskatoon, Saskatchewan, Canada
Email address: jvvdmerwe@me.com
ORCID iD for J.M. van der
Merwe:
0000-0001-9778-9594
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