Fuckmachine700 wrote:lasthope2.0 wrote:AMS 700 Reported Mechanical Malfunctions - January 2026 Updates from MAUDE DB
102 Mechanical Events out of 161 Adverse Events (63% are purely mechanical)
Survival Until a Mechanical Malfunction:
Max - 14 years
Mean - 4 years
Median - 4 years
<= 1 year 35%
2-5 years 26%
6-10 years 35%
11-15 years 3%
16-20 years 0%
https://www.fda.gov/medical-devices/med ... data-files
I appreciate all your work on this. Is there a dedicated surgeon with high-volume experience who can validate these numbers for us?
A surgeon cannot validate actual data. Keep in mind that these numbers refer only to failures. The time to failure is not out of all implants, just those that failed. The failure rate of all implants is very low and ten years, and even low at 15 years. The part that bothers me is the lack of any responsibility for how they failed. The manufacturers get away with just saying it is wear and tear. There is no real accountability on anyone’s part, no real reporting of what went wrong, no requirement to send in the failed implants for inspection. Nothing, really.
