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Catastrophies and Misunderstandings

Discussion in 'Knee Replacement Recovery Area' started by Larosser, Mar 15, 2012.

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  1. Larosser

    Larosser Member

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    It seems that I've touched some nerves with a couple of folks around here. It wasn't my intent to frighten anyone or sow hate and discontent, but apparently I've done so. I'm sorry for that. I believe we are misunderstanding one another, perhaps because we have different perspectives.

    Jo and Celie are medical folks, so their focus the body and medical procedures. I'm an engineer, so my first thought tends to be about devices and manufacturing. While to some folks that apparently seemed like sensationalism, I do not see it that way at all.

    First of all, the fact that a product has had recalls (or non-recall design revisions) against it does not make it a "bad" product. The problems addressed by recalls are typically either manufacturing issues with a specific batch or batches (which has nothing to do with the design) or subtle design issues that are only discovered based on long term field studies. In other words, the product was good enough to get through factory testing and initial trials. and most of them will work just fine. A manufacturing recall may affect only a small number of devices made at a specific location and time. A design recall often addresses problems in a very small group of people, probably statistical outliers. For example five failures in one thousand devices (half a percent) might prompt a recall if statistical modeling had predicted only one failure in ten thousand.

    However, a recall or design revision is one of the first things that I as an engineer would check off when I hear that a device isn't working and the folks who work with it regulary don't understand the problem. Why? because design flaws and manufacturing errors change the rules. A person can handle the device correctly, the device can pass all tests, and it it still won't "act right". Checking for such things is pretty quick to do, and even though it's only the answer in a small percentage of cases, it can save lots of time and grief to find out early if a design or manufacturing issue could be in play.

    So, all I was suggesting that okiegal do is get that out of the way. My cousin the doc added the suggestion that device manufacturers will also sometimes act as champion for patients when they have trouble getting the surgeon's attention. Nether of those suggestions was intended to frighten anyone, and I stand by the position that at least the first suggestion was reasoable.

    I'd also like to address two specific points that Celle brought up.

    First off, to an engineer at least, a "catastrophic failure" means a sudden and major loss of funtion - which is exactly how Celle described the failure of her PKR. I was not implying any criticism of the implant or the surgeon, just describing the nature of the failure.

    And regarding Oxford knees, there was indeen a Class 2 recall of the Biomet Oxford Unicompartmental Knee, related to the motion between the plastic tibial bearing and the metal tibial baseplate. At first blush, it seemed to match the description of the revision made to the part, but upon further reading, it had to do with mixing up lefts and rights, so this probably didn't apply to Celle's specific case. So while you all can still properly assert that I jumped to a conclusion, it was really just a little hop and not a massive lunge.

    If Jo, Celle or anyone else is still reading this, I appreciate your patience. I hear and understand that both of you thing that mechanical failures in replacement knees are unlikely to be the cause of a post replacement issue, and I bow to your superior experience in that regard. I hope you understand my position as well - that its worth checking that box off when faced with a frustrating and inexplicable issue, and more importantly, that I had no malice in making the suggestion amd was surprised and hurt to be treated as if I did.

    Best regards
    La
  2. Jamie

    Jamie Administrator

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    La.....would it be possible for you to place a link to the thread you are referencing in this post? I'm not sure I know the conversation you are referring to...... @Larosser:
  3. Larosser

    Larosser Member

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  4. Celle

    Celle Forum Advisor

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    La,

    Thank you for writing this. It took courage.

    I accept your explanation and our different perspectives. My husband is an engineer, and we often have discussions from different perspectives.

    I can understand how, from your perspective, my PKR failure was catastrophic. However, to me it was not. Yes, it was painful; yes, it was inconvenient; but, to me, it was not catastrophic.

    This is why. Back in 2001, my 27-year old son was discovered lying by a river bank, close to death. He had been missing for 3 days. No-one knew what had happened to him, but he appeared to have been assaulted and thrown into the river.

    When found, he had minor head injuries (he does not remember what happened to him) and he had sustained an injury to his leg which resulted in it having to be amputated above the knee. The poisons from the dying leg had affected his kidneys and put him into kidney failure. He was on kidney dialysis for 5 days and spent 10 days in Intensive Care.

    Now that, to me, was catastrophic. Beside that, my failed PKR seems rather insignificant. I've got a new knee now, and it is doing fine.

    He did make a full recovery and now walks well on his artificial leg, without using a stick.

    Thank you for the information about the Oxford knee recall. I was not aware of that. However, my implant was not one of the models recalled.

    Best wishes in your recovery,

    Celle

    PS: It's Celle, not Celie.
  5. Jamie

    Jamie Administrator

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    Thanks to both of you!!!
  6. Larosser

    Larosser Member

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    Celle, thank you for your gracious response, and I apologize for getting your name wrong. I will edit the original to fix, if you don't mind.

    Thanks so much for sharing your son's story. I have four daughters and I hear where you are coming from. After something like that, you probably don't consider much of anything a catastrophe! I certainly didn't mean "catastrophic" in the sense of what you described. Engineers tend to use that term to mean "that sucker quit working abruptly and completely", but in NO WAY is it similar to what you, your family and your son went through. I'm very glad to hear he's doing well now, and thanks again for responding as you did.

    Best
    La
  7. Celle

    Celle Forum Advisor

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    Hi La,

    Terminology is a pain, isn't it? :biggrin:

    Best wishes,

    Celle
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