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Zimmer NexGen Recall?

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Washington, DCAttorneys, knee surgeons and even former Zimmer consultants are all calling for a Zimmer NexGen recall, fast on the heels of a NexGen Complete Knee Solution recalled by the FDA last September 2010.

The reason for the FDA's recall of Zimmer NexGen complete knee solution MIS total knee procedure stemmed tibial component is eerily similar to problems now facing Zimmer with its NexGen CR-Flex artificial knee replacement: Zimmer received complaints of loosening of the implanted device requiring revision surgery.

According to the FDA, of 114 MDRs (medical device reporting) filed, all of them reported that the NexGen MIS device loosened and the patient required additional surgery to replace the device. The FDA issued the recall based on a 2010 study by two orthopedic surgeons who reviewed the NexGen MIS revision and failure rate. They determined that MIS Tibias placed without a stem component failed 24 percent of the time, compared to those with stem components which failed only 4.2 percent.

This recall leads to two obvious questions: What other Zimmer Knee Implants have these problems, and should all Zimmer artificial knees be recalled?

Zimmer doesn't have a good track record: In 2008, the manufacturer suspended sales of its Durom Cup, until it could "update the label with instructions about special surgical techniques to be followed during total hip replacements."

And just like its Durom Cup, Zimmer is blaming surgeons rather than considering that the Zimmer NexGen CR-Flex is defective. Zimmer issued a statement that negated the findings of Doctors Berger and Valle, who claimed that "loosening and revision [of Zimmer's NexGen CR-Flex Porous Femoral component] were not related to surgeon, approach or patient type." Rather, the company claimed that the surgeons simply implanted their devices incorrectly, and noted that the Australian National Joint Replacement Registry revealed a high success rate.

Zimmer is also quick to point out that NexGen has not been recalled—yet. According to the company Web site (Nexis, January 25, 2011), "Recent television and internet advertisements by plaintiff attorneys have featured misleading information regarding revision rates and alleged recalls of products in the Zimmer(Registered) NexGen(Registered) knee replacement family… It is important to note that the FDA has never ordered a recall on any of the NexGen family of products."

Zimmer has good reason for concern. According to a filing with the Securities and Exchange Commission, Zimmer sold more than 150,000 Zimmer NexGen knee implants since 2003. Furthermore, the NexGen products made up 2 percent of the company's $1.76 billion sales in 2009. Perhaps the company might want to squirrel away some of its profits for NexGen lawsuits—recall or not.

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READER COMMENTS

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on
I am from Denmark, I have the same knee as Venita and Debra and I agree with Debra we ar alot of patients in Denmark having the same problems as her. I have had my knee for 3 years now, just 2 days after my operation I got problems, allergy against the components in the track, it was nickel, chromium, cobolt and epoxy, I have it all over my body. I am tested by a Dermatolog, I have the same as Debra Beckey and much more, course the bone cement SmartMix with Gentamicin they also used for holding the knee have given me bone-cement-allergy, and that is also very bad.
Preoperative Identification of a Bone–Cement
Allergy in a Patient Undergoing Total Knee
Arthroplasty
Kevin Kaplan, BS,* Craig J. Della Valle, MD,* Kathleen Haines, MD,†
and Joseph D. Zuckerman, MD*
Abstract: Allergy to polymethyl methacrylate bone–cement or its components is
unusual. Because of the potential for an inflammatory response in an allergic patient
and the possibility of pain and loosening if a cemented implant is used, it is
imperative to identify patients with this allergy to modify their treatment. We report
the case of an otherwise healthy 60-year-old woman who needed a total knee
arthroplasty and who had an allergy to methyl methacrylate bone–cement identified
preoperatively. The appropriate evaluation for a patient who is suspected to have an
allergy to bone–cement or its components is reviewed. Key words: allergy, bone–
cement, knee, arthroplasty.
Copyright 2002, Elsevier Science (USA). All rights reserved.
Hypersensitivity reactions to the various components
used in total joint arthroplasty, including
metallic components and bone–cement, have been
described [1–4]. Allergy to polymethyl methacrylate
bone–cement or its components is unusual but
has been reported in several different settings, including
dentistry, orthopaedic surgery, the printing
industry, and as a reaction to cosmetics [5–7]. Because
of the potential for an inflammatory response
in an allergic patient and the possibility of pain and
loosening if a cemented implant is used, it is imperative
to identify patients with this allergy to modify
their treatment. We report the case of an otherwise
healthy 60-year-old woman who needed a total
knee arthroplasty and who had an allergy to methyl
methacrylate bone–cement identified preoperatively.
The appropriate evaluation of a patient who
is suspected to have an allergy to bone–cement or
its components is reviewed.
Case Report
A 60-year-old woman presented with a 10-year
history of progressively worsening right knee pain.
The patient described pain and a giving-way sensation
of the right knee with a significant increase in
severity over the past year. Treatment provided by
her primary care physician included anti-inflammatory
medications and hyaluronate injections, which
initially were effective, but her pain and disability
recurred.
From the Departments of *Orthopaedic Surgery and †Rheumatology,
New YorkUniversity–Hospital for Joint Diseases, New YorkCity, New
York.
Submitted October 30, 2001; accepted January 16, 2002.
No benefits or funds were received in support of this study.
Reprint requests: Joseph D. Zuckerman, MD, Department of
Orthopaedic Surgery, 14th Floor, New York University–Hospital
for Joint Diseases, 301 East 17th Street, New York City, NY
10003.
Copyright 2002, Elsevier Science (USA). All rights reserved.
0883-5403/02/1706-0020$35.00/0
doi:10.1054/arth.2002.33571
The Journal of Arthroplasty Vol. 17 No. 6 2002
788
Physical examination revealed an antalgic gait
with 5° varus alignment of the right knee. Tenderness
was noted on patellar compression and over
the medial joint line with pain at the extremes of
flexion. Range of motion was 0° to 105°. There was
no significant collateral or cruciate ligament laxity.
Radiographic examination showed advanced degenerative
arthritis with significant involvement of
the medial and patellofemoral compartments. A
right total knee arthroplasty was indicated.
Further history revealed that the patient had
experienced an allergy to artificial acrylic-based fingernails.
She explained her hands were extremely
irritated and the nails were removed after a brief
period. The patient also had experienced blisters in
her mouth as a reaction to a temporary filling that
was placed before the permanent filling. The patient’s
dentist diagnosed her with an allergy to
methyl methacrylate. The patient reported no other
known allergies to metals or to hair coloring.
To confirm the methyl methacrylate allergy,
patch testing was done with a test panel of bone–
cement components (Palacos Bone Cement; Biomet,
Warsaw, IN). This panel included 2% and 4%
weight-to-weight mixtures of the liquid monomer
methyl methacrylate (also contains N,N-dimethylp-
toluidine, hydroquinone, and chlorophyll) in petrolatum,
methacrylate copolymer powder (also
contains di-benzoyl peroxide, zirconiumdioxide,
and chlorophyll), a patch of solidified bone–cement,
and a control consisting of petroleum jelly.
On examination 72 hours later, erythema and induration
were noted in the areas exposed to the
polymerized bone–cement and to the 2% and 4%
mixtures of liquid monomer methyl methacrylate.
The methacrylate copolymer powder and control
elicited no reaction. Because the patient reacted to
the liquid methacrylate monomer and to the polymerized
bone–cement, we decided the use of a
cemented total knee arthroplasty was contraindicated.
The patient underwent a right total knee arthroplasty
using noncemented, porous ingrowth components.
Her postoperative course was uneventful,
and at 2 years postoperatively, the patient was
walking unlimited distances without assistive devices.
Active range of flexion was 0° to 125°. She
was able to do all of her activities of daily living.
Discussion
Allergy to methyl methacrylate bone–cement or
one of its components should be considered a contraindication
to the use of cemented implants.
Haddad and Cobb et al [8] described 7 patients with
a history of rapid aseptic loosening of cemented
total hip arthroplasties who displayed a hypersensitivity
reaction to N,N-dimethylparatoluidine (an
accelerator found in the liquid methacrylate monomer
component of bone–cement). An allergy to 1
of the constituents of bone–cement may cause an
enhanced inflammatory reaction and accelerate the
process of aseptic loosening. Although there are few
long-termstudies in the literature reporting the
outcome of implantation in methyl methacrylate–
allergic patients, we believe that cemented implantation
in such patients places themat risk for a
systemic inflammatory response (which may
present in a variety of patterns [9]) and implant
failure resulting fromaseptic loosening. In the case
presented, the patient had a hypersensitivity to the
liquid methacrylate monomer (and polymerized
bone–cement), although it is unclear to which
component of the monomer she was specifically
hypersensitive because direct testing of the various
monomer components was not done.
The currently accepted model of contact allergy
describes a delayed-type hypersensitivity reaction
that develops in a genetically susceptible individual
[9]. A hapten, such as N,N-dimethylparatoluidine,
conjugates with a body protein, which creates a
neoantigen capable of stimulating an immune response.
This unique antigen is processed by dendritic
cells or macrophages and presented to T cells,
generating a cell-mediated, inflammatory response
[9,10].
Acrylates, which are grouped under the more
generic name of acrylics, have a chemical structure
allowing excellent adhesive capability. This material
is used extensively in dental and orthopaedic procedures.
Patients may come in contact with acrylics
in cosmetics, paint, hearing aids, inks, surgical tape,
rubber stamp making, and various other materials
[11–15]. A thorough patient history is likely to
uncover any exposure to these materials. In this
case, our patient described prior exposure to acrylic
fingernails and acrylics in a temporary dental implant,
which enabled us to confirmthe allergy and
modify her treatment.
Contact dermatitis resulting from exposure to
methyl methacrylate was reported in 1941 [16].
Several reports in the early 1970s involving dermatitis
and loosening of the prosthesis alerted physicians
to the possible role of a delayed-type hypersensitivity
reaction to methyl methacrylate [17].
Monteny, Oleffe, and Donkerwolke [17] reported a
case of a 76-year-old patient with a cemented endoprosthesis
who experienced an allergy to methyl
methacrylate monomer. Patch testing in this patient
Bone–Cement Allergy in TKA Patient • Kaplan et al. 789
was strongly positive at several different concentrations
of methyl methacrylate monomer. These authors
hypothesized that methyl methacrylate
monomer, when pushed into the injured bone
blood vessels during implantation, acts as the allergen
to which the patient mounts an immune response.
Monteny, Oleffe, and Donkerwolke et
al [17] did not report the long-termfollow-up or
treatment of this patient.
Romaguera, Grimalt, and Vilaplana [18] reported
a case of a 31-year-old patient with a fracture of the
left femur who developed a deep infection after
surgery that was treated with methyl methacrylate
beads containing gentamicin. Fifteen days postoperatively,
an eczematous patch was found on the
patient’s thigh. Later the patient experienced generalized
urticaria and edema of the eyelids. The
patient had no previous allergic history but had a
family history of atopy. Patch tests were positive to
several concentrations of methyl methacrylate. On
removal of the beads, the lesions disappeared.
Foussereau and Cavelier et al [19] and
Romaguera and Vilaplana et al [20] reported 2
separate cases of contact sensitivity to methacrylates
in limb prostheses. Foussereau and Cavelier
[19] reported a patient who experienced a reaction
froman above-the-knee prosthesis, whereas
Romaguera and Vilaplana [20] described contact
sensitivity in a patient using a newly varnished
prosthesis contaminated with acrylates. Other examples
of allergy to methyl methacrylate in various
settings have been reported in the literature. Kassis,
Vedel, and Darre [21] reported 2 cases of contact
dermatitis in nurses working with acrylic bone–
cement. Freeman, Lee, and Gudmundsen [22] reported
4 cases of contact reactions to sculptured
acrylic fingernails. Methyl methacrylate, because of
its success as a potent adhesive, can be encountered
in different settings leading to possible sensitization.
In patients with suspected allergy, we recommend
the following approach. A complete patient
history and physical examination are essential and
can provide fundamental information regarding a
possible allergy. In addition, obtaining records from
the patient’s previous physicians may be useful in
suspected allergy patients. In our case, the patient
reported an allergy to acrylic fingernails and to a
temporary dental implant. Work-up for an allergy
to polymethyl methacrylate bone–cement or 1 of its
components includes evaluation of a patch test.
This test gives the most accurate information on the
patient’s allergy status. Evaluation can use a standard
methacrylate series ((Meth)Acrylate Series
MA-1000: Adhesives, Dental & Other/(Meth)Acrylate
Series MN-1000: Nails-Artificial/Dental Series;
Chemotechnique Diagnostics, Tygelsjo, Sweden)
followed by placement of the antigens on the patient’s
back. The test site is examined at 72 hours to
detect a delayed-type hypersensitivity reaction,
manifested by edema, erythema, and vesicles [9].
An alternative method to conduct the patch test, as
was used in our patient, involves formulating a 2%
weight-to-weight mix of diluted liquid methacrylate
monomer, the methacrylate copolymer powder,
and polymerized bone–cement each in petrolatumand
applying these to the skin. Further
treatment of the patient should be based on conclusions
drawn fromthe history, physical examination,
and results of the patch testing.
The literature does not definitively report the
prevalence of patients allergic to methacrylate. A
study in 1980 reported, however, that in a cohort of
42 patients undergoing implantation of hip prostheses
using cement containing methyl methacrylate,
approximately 25% of the cohort showed a positive
patch test 6 months after the operation [23]. With
continual advances in cosmetics, dentistry, and various
other industries, exposure and sensitization to
methyl methacrylate may be rising. It is important
to conduct a complete patient history and physical
examination to detect this potential allergy before
implantation of components with cement.
References
1. Waterman AH, Schrik JJ: Allergy in hip arthroplasty.
Contact Dermatitis 13:294, 1985
2. Deutman R, Mulder TH, Brian R, Nater JP: Metal
sensitivity before and after total hip arthroplasty.
J Bone Joint Surg Am59:862, 1977
3. Rooker GD, Wilkinson JD: Metal sensitivity in patients
undergoing hip replacement: a prospective
study. J Bone Joint Surg Br 62:502, 1980
4. Haddad FS, Levell NJ, Dowd PM, et al: Cement hypersensitivity:
A cause of aseptic loosening? J Bone
Joint Surg Br 77:329, 1995
5. Johnson DR, Mathias CGT: Case report: A dentist
with allergic contact dermatitis caused by ethylene
glycol dimethacrylate. Am J Contact Dermatitis 4:90,
1993
6. Fisher AA: Parasthesia of the fingers accompanying
dermatitis due to methylmethacrylate bone cement.
Contact Dermatitis 5:55, 1979
7. Malten KE, Sewtter E: Contact dermatitis from acrylated
resins in UV Ebecryl printing inks. AmJ Contact
Dermatitis 3:142, 1992
8. Haddad FS, Cobb AG, Bentley G, et al: Hypersensitivity
in aseptic loosening of total hip replacements:
the role of constituents of bone cement. J Bone Joint
Surg Br 78:546, 1996
9. Guin JD: Practical contact dermatitis. McGraw Hill,
New York, 1995.

Today I am going to have a revision of the Zimmer and the doctors in Denmark are giving me another type of knee without bone cement. They told me that the damage the Zimmer knee have done to my health I will have the rest of my life and I am only 57 years. So for 3 years some of the doctors in Denmark have lied to me, about the knee and the bone cement.

Posted by

on
yes i have had to quite work because of this knee i was thinking i could go back to work but knee want bend at all and its very painful dr said i could break my leg by just standing so i just set now i have gained 100 pounds because i;m afraid to move and the pain and now my other knee is gone but i;m not letting it go i well go to a wheel chair before i will go though another surgery i am terrified now i have had 3 surgerys in the knee and it still does'nt work scraed to death can't get any help to sue them to get my life back .

Posted by

on
I think that all Zimmer NexGen Knee Replacements should be recalled! I have suffered emotionally, mentally, and physically from this defective product. Everyday of my life is a constant struggle dealing with swelling, throbbing, locking, buckling, and even feeling the rod in the lower leg. I have pain when I bend, sit, stand, and sometimes just moving around. I have pain in the knee area that have brought tears to my eyes, because I don't know what to do. Heating pads, icing, physical therapy, and even water therapy has not helped. Doctor's say" you just have to live with the pain". NO, NO, NO! I should not have constant pain. This is not normal. I've had this surgery in 2004, and now it is 2011. A seven year problem that I've dealt with. Sometimes, I suffered silently, and yes, I have asked for help. They-(the Doctor's), I think knew for awhile about this forgoing problem and didn't alert to concern for these patient's, as well as the company who put this defective medical product out. Well, I refuse to hold my tongue anymore and take a stand on this issue. This company before it is all over, will have a rude awakening, not only from myself, but from others and need not be afraid to speak up and put a voice against this company. I'm sure there are others who have pain and are afraid to get legal help. Hey! DEFECTIVE IS DEFECTIVE! Just please get help for your problem!

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