Stryker Howmedica Osteonics has recently recalled some of the implants
(stems) from thier Modular Replacement System. I am trying to find out
more specifics of why this product was recalled. This is the reason
they give in the recall report:
"Some components have disassociated post-operatively resulting in
additional surgery to the patient."
What caused the disassociation of parts? Manufacturing issue?
I need a more detailed reason. There was a letter sent out earlier
this year about therecall. If you could get a copy that would be
great.
Note: I need the answer by Friday, April 4th.
Information on the Product recalled:
http://www.howost.com/kneesystems/mrs/text.php
FDA Recall information (about half-way down the page):
http://www.fda.gov/bbs/topics/enforce/2003/ENF00786.html |
Request for Question Clarification by
aceresearcher-ga
on
28 Mar 2003 10:08 PST
Greetings, ase!
As the recall is so new, there does not appear to be any detailed
information relating to it yet on the web that has been indexed by
Google and other Search Engines. However, I have left messages both at
the FDA and at Stryker Howmedica Osteonics requesting a little more
detail about the nature of the malfunction; hopefully one or both of
them will get back to me before they leave for the weekend.
As soon as I hear something, I will let you know.
Regards,
aceresearcher
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Clarification of Question by
ase-ga
on
28 Mar 2003 13:34 PST
Great effort - aceresearcher,
As a recommendation you might try to ask for the Product Manager for
the MRS System at SHO.
Let me know what you are able to find and if you have any questions.
Thanks,
ase
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Request for Question Clarification by
aceresearcher-ga
on
01 Apr 2003 08:52 PST
ase,
I spoke with a representative at the FDA; for detailed information
regarding the reasons for recall, one must submit an FOI (Freedom of
Information) request. I do have for you the information on how to do
that; however, the representative with whom I spoke said the
turnaround time for such a request is usually 2 weeks.
I also spoke with a representative at Howmedica; she said she would be
willing to provide me with details, but needs the specific part number
in question to do so; just giving her the list of part numbers from
the FDA recall notice was not acceptable.
If you can post the part number(s) about which you are asking, I will
obtain the detailed failure information for you.
Regards,
aceresearcher
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Clarification of Question by
ase-ga
on
08 Apr 2003 15:23 PDT
Hi aceresearcher,
Sorry for the delay. If you could check on these I would appreciate
it. I think focusing on "Why" in your questions would be best. I
will be faster to respond this week.
Thanks,
ase
6485-3-017 D6BZC MRS 17MM X 127MM FEMORAL STEM;
6485-3-311 D6CAB MRS 11MM X 203MM FEMORAL STEM;
6485-3-311 D6GTB MRS 11MM X 203MM FEMORAL STEM;
6485-3-313 D6GWC MRS 13MM X 203MM FEMORAL STEM;
6485-3-317 D6GM MRS 17MM X 203MM FEMORAL STEM;
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Request for Question Clarification by
aceresearcher-ga
on
08 Apr 2003 17:19 PDT
Thanks for responding to my request for additional information, ase.
Here's the problem: The representative to whom I spoke at Howmedica
was quite clear that they would not respond to a blanket request for
information -- I need to provide them with the specific part number(s)
for the person in question (although they did tell me they would do so
without requiring me to reveal the identity of the person for whom I
was making the request).
Howmedica would be willing to talk to me if I were a representative
for someone who wants to know about the failure reasons for a specific
part. However, you are asking for the failure reasons for 5 nearly
identical parts, that can't possibly all have been installed in one
person. Therefore, it is quite logical that they will suspect that I
am asking on behalf of an attorney. If they believe that, I do not
think that they will be willing to give me any information.
I can provide you with the correct procedure to make an FOI (Freedom
of Information) request of the FDA, and I can provide you with the
contact information for the person with whom I spoke at Howmedica.
Would you be willing to consider that an acceptable Answer?
Thanks,
ace
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