Coloplast Titan Mechanical Malfunctions - January 2026 Updates from MAUDE DB

[lasthope2.0]

Events Analyzed = 71/122

Explanted for Mechanical Malfunction:
Max - 20 years
Mean - 5 years
Median - 4 years

<= 1 year 20%
2-5 years 42%
6-10 years 25%
11-15 years 8%
16-20 years 4%

https://www.fda.gov/medical-devices/med ... data-files

[ready2go]

Events Analyzed = 71/122

Explanted for Mechanical Malfunction:
Max - 20 years
Mean - 5 years
Median - 4 years

<= 1 year 20%
2-5 years 42%
6-10 years 25%
11-15 years 8%
16-20 years 4%

https://www.fda.gov/medical-devices/med ... data-files

so close to 50% within 2-5 years , not very good ,considering the expense and the surgery/ recovery time

[lasthope2.0]

Events Analyzed = 71/122

Explanted for Mechanical Malfunction:
Max - 20 years
Mean - 5 years
Median - 4 years

<= 1 year 20%
2-5 years 42%
6-10 years 25%
11-15 years 8%
16-20 years 4%

https://www.fda.gov/medical-devices/med ... data-files

so close to 50% within 2-5 years , not very good ,considering the expense and the surgery/ recovery time

One argument is that these are only for malfunctioned implants. For hip, knee, breast, and dental implants, there are registries of surviving implants. We need a registry for surviving dick implants. I have no doubt that SMSNA will come up with one.