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Recalled Sulzer
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Recalled Sulzer Inter-Op™ Shells

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

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~

 

Sulzer Patient Letter

 

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

 

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

www.ashcraftandgerel.com

www.sfgate.com archive 2001/02/18

www.sfgate.com archive/2001/02/13

ABC World News Tonight ~ hip repreplacement_feature

CNN Health 1/17/01 Hip Replacement

http://www.masstorts.com/hipreplace/faq.html
http://www.recalledhip.com/
http://www.sulzer-hip-replacement.com/ 
http://www.schragbaum.com/
http://www.klein-paikoff-law.com/sulzer/
http://www.newyork-injurylawyers.com/pages/sulzer_hip_replacement.html
http://www.elslaw.com/hip.htm
http://www.wdolaw.com/default.html
http://www.santolilaw.com/faq/faqhip.html
http://www.chron.com/cs/CDA/story.hts/women/health/788942
http://www.safetyalerts.com/recall/f/004/sulzer.htm
http://www.miix.com/riskalerts.htm
http://pgglaw.wld.com/article.htm
http://firms.findlaw.com/dabjr2/
www.SulzerHipImplantNews.com

St. Petersburg Times ~ Bay area ripe for hip litigation

 

 


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