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| The Sulzer
Inter-Op™ acetabular shells
subject to the recall are as follows: |
| Shell Product |
Catalog Numbers |
Lot Numbers Beginning # |
Lot Numbers Ending # |
| Hemispherical |
4360-00-039 through
4360-00-065 |
1307848 |
1465372 |
| Rim Flare |
4361-00-039 through
4361-00-071 |
1398234 |
1465247 |
| Revision |
4362-00-043 through
4362-00-081 |
1397531 |
1465242 |
| Protrusio |
4363-00-053 through
4363-00-081 |
1403576 |
1453540 |
|
List of Symptoms
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| The
following are indications of problems with a Sulzer Inter-Op™ hip
implant: |
| Up
to 6 weeks after hip replacement surgery: |
- The patient may be progressing well or reporting groin or
anterior trochanteric pain;
- The patient may have increased thigh pain;
- The patient has significant startup pain with ambulation
(walking) or, rising from a seated position, may have buttock
pain; and
- An x-ray may show possible component migration.
|
| 6
weeks to 3 months after hip replacement surgery: |
- The patient may experience significant pain with weight
bearing, and may require a cane or crutch; and
- The patient may be unable to exert resistance in a straight
raised leg test and a side-lying abduction test.
|
Note: None of the listings below have paid to have
their letters or links placed here, I place them all here solely for the
purpose of research on the hip recall.
~ Linda May-Bowser~
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Jan 26, 2001
Dear Mrs. May-Bowser:
We at Sulzer Orthopedics are aware of the public service you provide to
the orthopedic patient community by promoting the sharing of information
between patients on your site http://www.totallyhip.org.
Your personal story, and your commitment to helping patients learn more
about hip surgery, has clearly helped a great number of people.
We know that the recent voluntary recall of selected manufacturing lots of
the Inter-Op acetabular shell has caused great concern. We want to
let you know that we are committed to working with patients and surgeons
to address all of the concerns raised by this recall.
The reason for the voluntary recall of selected lots of the Inter-Op
acetabular shell is that we were able to find a slight residue of a
lubricant on the exterior porous surface of the shell which we believe can
impede the bone from bonding to the shell. Upon learning this, we
immediately recalled all the affected products. Approximately 25,000
shells were affected ; 17,500 of these were implanted in patients.
Normally, the bone would form an integrated bond with the shell; however,
it appears that bone does not always bond with shells when the lubricant
residue is present. Reported symptoms include severe groin pain and
inability to bear weight on your leg. These symptoms are caused by the
shell being loose from the bone. Patients experiencing these
symptoms, are urged to contact their physician. Please note that our
surgeon advisors do not recommend that patients undergo removal of the
part unless they exhibit symptoms of loosening.
We at Sulzer Orthopedics apologize for any effect that this
voluntary recall may have on patients and their families. We will do our
very best to address patients' individual needs and concerns that are a
result of this recall. We know that one concern will be the additional
costs that patients may incur because of further medical attention. Please
rest assured that Sulzer Orthopedics will reimburse patients for related
out-of-pocket expenses not reimbursed by insurance or Medicare. Sulzer
Orthopedics is dedicated to resolving any healthcare problems associated
with this implant recall.
On Jan 18, 2001, we announced that we had implemented a series of
new cleaning procedures in the manufacturing of our Inter-Op acetabular
shells.
With the introduction of the revised rigorous cleaning process, we at
Sulzer Orthopedics are confident we have solved the cause of last month's
recall.
After thorough investigation of our other products, Sulzer
Orthopedics is confident that no other products are affected by this
phenomenon.
To assist patients affected by this recall, and to answer some of the
questions patients may have, we have set up a toll free telephone number.
The number is 800-888-4676 ext. 232. We have also used our
website to inform people about the recall and the steps we have taken to
work with patients, and to identify and solve the problem.
Best regards,
Amanda Rose, Sulzer Orthopedics Inc.
amanda.rose@sous.com
Patient Inquiries: 1-800-888-4676, ext. 232 |
Posting from Totallyhip
Discussion Board #1
Sulzer recall Summary Revisited!
Thu Feb 15 09:48:25 2001
This is Bill's hard work on the recall matter posted again for those new
to www.totallyhip.org
Let's Try to Summarize Recall, Revision, Recourse, etc.
Wed Feb 7 16:26:55 2001
I joined the fray on the Sulzer Recall in early December and have
monitored and commented on this site since that time. It seems that every
day a new victim shows up with the same questions and concerns us
"vets" had two months ago and one of us advises the concerned
new victim to read inputs on this site. I thought it would be a good idea
to recap for the new victim what I think I know and invite your input,
update, and corrections as you see fit. SOooooo.....here goes.
1. Sulzer Medica announced on 8 Dec 2000 that it's subsidiary, Sulzer
Orthopedics(SO), had recalled certain lot numbers of the Inter-Op
Acetabular shell due to a manufacturing residue that affected bone shell
bonding . I believe SO actually put the recall letter out to the OS
community on 5 Dec 2000. Their OS letter contained the effected lot
numbers, identified physical symptoms associated with a bad shell along
with a time table of when symptoms would normally show up, and provided
instructions for the type of x-ray to use that would verify bone/shell
loosening. Sulzer also provided a patient toll free number.
2. Although not instructed to do so by Sulzer, it was implied that OS's
should contact the affected patients. Evidently, some did and some didn't.
3. Sulzer stated that they became aware of the problem in September 2000,
60 reported cases at that time, but did not initiate the recall until
December 2000. Posts on this site imply that some OS's stopped using the
Sulzer shell as early as September 2000 suspecting something was wrong but
did not know what it was.
4. Sulzer implied that if a patient was going to have a problem it would
show up in three months post op. Posts on this site have indicated that
problems have materialized well past three months.
5. Indications are that revision surgery has been more difficult than the
original surgery. Blood loss seems to be prevalent and scar tissue has
presented a problem.
6. Patients who had their shell secured with screws, one or two, are
having difficulty getting x-rays to validate loosening.
"Screwed" patients seem to have less pain and OS's prioritize
them at the bottom of the totem pole.
7. The FDA has been noticeably absent in this entire process.
8. Some OS's are using Sulzer shells manufactured with the new cleaning
process or recycled shells that have been re-cleaned.
9. Some OS's refuse to use the Sulzer product.
10. So far, those who have received revision surgery have gotten immediate
relief.
11. The recall debacle has received national, and probably international,
attention. ABC nightly news and CNN have featured the situation during
prime time.
12. Product liability suits have sprung up all over. This to has received
attention in newspapers around the country.
Whhhhh.....ew. Help me out.
13. The two web sites of interest for contacting the manufacturer are; www.Sulzermedica.com
Has a recall letter info and the latter has a FAQ section that is very
informative.
14. The symptom time table provided by SO does not apply to everyone. Some
patients have experienced problems immediately after surgery and some have
gone several months before symptoms showed up.
15. Not all revision surgeries have been difficult. Not sure what this
means but earlier I stated that they were.
16. I did not know this but evidently Sulzer provided OS's
with two recall letters; one for affected patients with surgery dates
between Oct 99 and June 00 and those who had surgery between July 00 and
the Dec 00 recall date. Not sure why this was done since a June/July date
has not surfaced. Mid September 00 was the date Sulzer says they started
receiving reports on post operative loosening of the shells. So what is
the importance of splitting patient letters between June and July 00? Why
not one letter for all who received the shells since Oct 99. Hmmm... Do I
smell a rat?
17. Earlier I mentioned that the FDA has been suspiciously absent from
this debacle. I cannot find any info on their national web site about the
recall nor where they approved Sulzer's new manufacturing process that
supposedly fixed the problem. I brought this up for two reason: first,
Sulzer said they notified the FDA of the recall and the fix for the
problem. If this is true why hasn't the FDA provided that info to the
public? Secondly, does the FDA carry some liability in this issue from a
public health hazard perspective for lack of notification. Reference the
new process, a post on this site implied that some surgeons were using Sulzer
shells that have the new cleaning process. If the FDA has not approved the
new process isn't that like having the Fox repair the hole in the chicken
house.
18. Symptoms associated with a bad shell can be confused with normal
recovery symptoms. This is true and some of us have been on the symptom
roller coaster: normal recovery, symptoms begin and last for several
weeks, symptoms subside but return, doc is confused, we are confused
because there is no explanation for the pain other than a bad shell, etc.,
etc., Apparently each situation is different and can be influenced by many
factors that are probably to lengthy to go into.
19. X-rays do not always show loosening. Those w/o screws seem to show
early on and those with screws do not and in some cases never do. Posts on
this site have indicated that even those that did not show loosening on
the x-ray were found to be loose during revision surgery.
Hope this is not getting out of hand. Tell me and I'll stop.
Question of the day. Has anyone experienced or heard of a revision surgery
specifically done to remove a bad cup/shell that did not verify the
cup/shell was loose. This info is important to those of us with bad cups
identified by lot number, experiencing all the symptoms of a bad cup but
x-rays do not show loosening. In this situation surgeons seem reluctant to
initiate revision surgery. |
|
February 19, 2001
Dear Ms. May-Bowser,
Here is some additional information that may be useful to some of the
Sulzer implant patients with questions about possible direct settlements
with the company.
Patients should be very careful about entering any
agreements with Sulzer to accept reimbursement for their out-of-pocket
expenses not covered by Medicare or private insurance. The reason is
that Medicare, and most private insurers, have rules that potentially
require patients to pay any such funds received to Medicare or to the
insurer to reimburse for the insurer's/Medicare's outlays for the same
incident.
The Medicare rules are called "Medicare as
secondary payer" and essentially provide that if someone else is at
fault for a patient's injury requiring medical care that Medicare would
ordinarily pay for, Medicare becomes the "secondary" payer and
the at-fault party becomes the primary payer.
If the patient enters a settlement with the party
deemed to be the primary payer, Medicare can seek to have these funds paid
over to it or has a variety of other remedies available to it.
Similarly, private insurance contracts almost always
have "subrogation" clauses that require the patient to cooperate
with the private insurer in seeking reimbursement of benefits it has paid
to doctors or hospitals that a party like Sulzer might be liable for.
Anyone considering a settlement should be aware of
these rules, which can come back to haunt someone months or years after a
settlement. The better practice is to negotiate a comprehensive
settlement in the first place that takes care of all claims including any
derivative claims of Medicare or private insurers.
Our firm represents Sulzer recall patients in the mid-Atlantic,
Washington, DC area. We represent individuals only and not
class-actions. Further information about the firm is available at
our web site, www.steinmitchell.com.
This contains links to a couple of articles by me for lawyers on drug
product liability litigation.
Keep up the great work with your web site!
Sincerely,
Patrick A. Malone
Stein, Mitchell & Mezines
1100 Connecticut Avenue
Suite 1100
Washington, DC 20036
202-737-7777
fax 202-296-8312 |
In McComb, Mississippi call:
Nancy Armstrong/Paul Guy, Jr., Armstrong & Guy
601-684-8816 or toll free 1-877-893-3797
William S. Guy/Thomas W. Brock, Law Office of William S. Guy
601-684-2793 or toll free 1-800-748-9043
Gary L. Honea, Attorney at Law
601-783-2036 or toll free 1-800-519-6220
*Free background material available upon request
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|
Feb.16, 2001
Dear Ms. May-Bowser:
My name is Stephen Cassidy and I am an attorney in San Francisco,
California. Our firm was contacted soon after the recall of the Sulzer hip
implant recall by hip implant recipients. We have taken a leading
role in educating Sulzer hip implant recipients, both those who have had
or are scheduled to have revision surgery and other that have no present
injury, but simply wish for further information.
As it has become apparent that Sulzer may have minimized the number of
people whose hip implants will fail when Sulzer announced the recall and
we have received more and more contacts, we created one of the first, and
I believe most comprehensive web sites on the recall, www.HipImplantLaw.com
I am responsible for the content on the web site, and have sought to
provide objective, useful information (not simply a solicitation for
clients as other Sulzer attorney web sites tend to be) while recognizing
that much information has yet to be uncovered. My law firm has a
team of attorneys, nurses and paralegals assigned to the case.
We have worked with a company in purchasing internet advertising for the
web site. I understand that the company recently contacted you
concerning advertising on your web site, and you declined. That is
perfectly understandable.
The list of product numbers for the recalled shells on www.HipImplantLaw.com
came originally from Sulzer and is factual in nature, so I have no
objection to your copying.
You should be aware, however, that on
Sulzer's web site, when they list the catalog numbers, it is highly
confusing because they use a "/". For example, the Sulzer
web site prints the catalog numbers for the hemispherical shells as
"4360-00-039/065." Many Sulzer hip implant recipients have
thought that this was one number, and that they were then safe. Our
investigation revealed that this was actually a range of numbers,
4360-00-039 through 4360-00-065. This explains why we have listed
the catalog numbers differently than on Sulzer's web site. I also note that you have listed two links to Sulzer's web site on your
Sulzer recall page. I understand fully why you would do that.
But please consider that Sulzer has a self-interest in minimizing the
problem, and has encouraged recipients to contact and "settle"
their claims with the company without speaking to any attorney.
The problem, of course, is that
Sulzer at all times has its own lawyers and no one at this point, except
Sulzer, knows what really occurred or how this defect took place.
I've read reports that Sulzer is seeking to obtain waivers of legal rights
and releases of claims from recipients.
I would request then that to achieve balance on your web site, that you
not just list Sulzer's web site, but have a list of links to attorney Sulzer
web site that you find offer worthwhile information. Keep in mind
that this case is at the beginning stages. There will be many
developments and court orders that your readers will be interested in as
time goes by (and Sulzer will never post on their web site). On www.HipImplantLaw.com,
we have already posted the complaint in one case, and we have a video clip
of Rhonda Silva (who was interviewed on CNN back in January) explaining
why Sulzer should be held accountable. I think many of your
readers would find this information of interest, and would appreciate a
link to our web site.
Thank you for your consideration of this request.
Stephen H. Cassidy
Lieff, Cabraser, Heimann & Bernstein, LLP
275 Battery Street, 28th Floor
San Francisco, CA 94111
tel: (415) 956-1000
fax: (415) 956-1008
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Click the links below
to explore the
TOTALLYHIP web site
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