Knee-Patella wear test

[srinu]

Dear All,
We got some strange questions from CE auditor that why the Femoral patella wear test was not done?
It's really new for us,there is no requirement for Femoral-patella wear test from standards (FDA guide,F2083,ISO21536 and ISO 21534).
All those standards listed the wear test between Femoral and tibial bearing, There is no such kind of requirement from FDA also, our product has been approved by FDA.
This question was raised by CE auditor.

Please suggest to me a counter answer technically that there is no requirement for femoral and patella wear test to prove safety.

All your suggestions are welcome.

Thank you.

 

[yodon]

First off, I expect we'll need more info about your product. Total knee replacement? I'm not real familiar with the standards in this space so hopefully someone else can chime in.

Second, bear in mind that FDA and EU are not always completely in line with expectations. What FDA accepts may well be different from what EU requires and vice versa.

Did your CE auditor cite a standard that they felt you should comply with?

 

[srinu]

First off, I expect we'll need more info about your product. Total knee replacement? I'm not real familiar with the standards in this space so hopefully someone else can chime in.

Second, bear in mind that FDA and EU are not always completely in line with expectations. What FDA accepts may well be different from what EU requires and vice versa.

Did your CE auditor cite a standard that they felt you should comply with?

Dear Yodon,
Our product is a Knee replacement system.
No, he did not suggest any standard, he raised a question that why not for patella and femoral ..we did between bearing and femoral.

 

[yodon]

(Sorry, here I go with questions again.) Does your risk analysis consider wear between patella and femoral? And does it conclude that there is no risk there? As noted above, I'm not all that familiar with joint replacement devices / knee replacement devices so I'm just trying to toss out some ideas. Do you know if there IS such a standard? If so, do you know if it's harmonized? Also if so, what was your rationale for not complying?

 

[srinu]

(Sorry, here I go with questions again.) Does your risk analysis consider wear between patella and femoral? And does it conclude that there is no risk there? As noted above, I'm not all that familiar with joint replacement devices / knee replacement devices so I'm just trying to toss out some ideas. Do you know if there IS such a standard? If so, do you know if it's harmonized? Also if so, what was your rationale for not complying?

Dear Yodon,
Yes, we did risk analysis and we did the wear between femoral and tibial bearing which is the most load-carrying joint compared to femoral and patella.
There is no joint-related ISO that suggests doing a test between the femoral and patella.

Any technical info is much useful to counter this question. Any technical persons please put your light on this topic.