Titan MAUDE Updates - May 2026

[lasthope2.0]

Coloplast Titan — May 2026 MAUDE Reported Lifespan at Mechanical Malfunction

Summary Statistics

• N: 66/129
• Mean: 7 years
• Median: 7 years
• Max: 34 years

Percent Distribution

• ≤1 yr — (12.1%)
• >1–4 yrs — (18.2%)
• 5–10 yrs — (48.5%) ← Highest Concentration
• 11–15 yrs — (12.1%)
• 16–20 yrs — (7.6%)
• 20–25 yrs — (0.0%)
• 25–30 yrs — (0.0%)
• >30 yrs — (1.5%)

Note:
5–10 years — nearly half of all reported failures occurred in this range. The single 34 year outlier is a notable exception; without it the max drops to 19 years.

Source: FDA MAUDE Database
Disclaimer: These are failure stats and not survival probability. Not professionally peer-reviewed and can have errors.

[lasthope2.0]

Summary of Events

1. Infection

1. Infection-driven explants are a recurring theme, with several devices removed and replaced by a malleable Genesis device specifically due to confirmed infection.
2. One detailed case involved a Type 2 diabetic patient who developed scrotal pain, fever, and rigors ~12 months post-implant, with Group B Streptococcus (Strep. agalactiae) cultured and periprosthetic fluid around the pump prompting explant without re-implantation.
3. Several "suspected infection" cases turned out negative on tissue testing — the IPP was explanted/replaced with a Genesis as a precaution, but no infection was confirmed (Coloplast concluded any infection would have originated from a source other than the sterilized device).

2. Malfunction
By far the largest category.

1. Tubing breaks/fractures/cracks are the single most common failure — most often at or near the pump, but also cylinder-to-pump junctions, reservoir tubing, the reinforced portion, and tubing connectors coming apart.
2. Inflation failures: devices that wouldn't inflate, inflated only partially, or progressively lost achievable inflation over consecutive activations (loss of hydraulic integrity).
3. Deflation/auto-deflation failures: devices that would inflate then slowly deflate, or could not be deflated at all (one caused patient pain and required full replacement).
4. Auto-inflation: devices inflating on their own, in some cases combined with impending extrusion.
5. Fluid loss: empty reservoirs found on CT or at surgery, indicating leaks — often traced to tubing between cylinder and pump, or suspected reservoir-tubing leaks.
6. Pump/valve mechanical failures: sticking pumps, pumps staying compressed, valves failing to hold pressure (inflating/deflating without valve activation), and rock-hard pumps the patient couldn't compress.
7. Cylinder failures: cylinder aneurysm/protrusion in the cylinder body, distal holes leaking bloody fluid intraoperatively, and a single cylinder failing to inflate.
8. Intraoperative device failures before implantation: pumps not maintaining pressure during prep, air bubbles/decompression in the pump forcing a full second device, and a distal cylinder hole found during deployment.
9. Many malfunctions are logged simply as "unspecified malfunction" or "leak" with no further detail.

3. Malposition

1. Reservoir herniation/migration: reservoirs removed/replaced for herniation, migration, lateral placement, or displacement caused by large patient weight loss; in some cases the device was downgraded to a Genesis.
2. Pump migration/malposition: pumps riding high or sitting too high in the scrotum, pumps placed too low or hard to reach (often attributed to insufficient tubing length), requiring repositioning or replacement.
3. Gland/distal-tip hypermobility ("floppy glans"): distal tips sitting too laterally or folding back on themselves (e.g., after a tunica expansion/grafting procedure), requiring re-tunneling and suture fixation within the glans.
4. Impending/near erosion and erosion: urethral erosion (including in a "virgin" implant), proximal cylinder erosion after rear-tip sling failure, and "near erosion" prompting cylinder swap-outs — several erosion cases were downgraded to a malleable Genesis.
5. Crossover, cylinder migration, and aneurysms: proximal cylinder herniation with Bioflex bulging, cylinder migration/folding, and cylinder aneurysms (protrusion in the cylinder body).

4. Patient Dissatisfaction

1. Size/sizing: incorrect sizing is a frequent revision reason — implants too short, too long, or undersized; in several cases only cylinders or cylinder+pump were swapped while the original reservoir was retained.
2. Rigidity: complaints of extreme pump rigidity (preventing use and causing pain, requiring tubing to be cut for removal) and lack of axial rigidity prompting revision.
3. Cosmetic/positioning concerns & other: dissatisfaction with pump location/reachability, patients seeking second opinions over perceived incomplete deflation, surgeon-driven intraoperative changes (e.g., switching to a malleable due to a urethral perforation risk), and assembly-kit issues (connectors with excess internal plastic, tubing that had to be trimmed).

[Wooody]

34 years?!?! Damn... that's the longest by far I've ever heard of. Lucky fucker!

[wilsonmill]

Are these results from just the USA or worldwide?

[lasthope2.0]

34 years?!?! Damn... that's the longest by far I've ever heard of. Lucky fucker!

He is from Colorado. He got his implant at the age of 36 and he's 70 now.

Reason for explant:
"Implant was removed and replaced due it not inflating and the cylinders looking irregular on ct."

[lasthope2.0]

Are these results from just the USA or worldwide?

Worldwide. Mostly from USA.
These are like vaccine adverse event reports. Everyone is supposed to report, but there may be events that can also go unreported or reported late.

[wilsonmill]

Are these results from just the USA or worldwide?

Worldwide. Mostly from USA.
These are like vaccine adverse event reports. Everyone is supposed to report, but there may be events that can also go unreported or reported late.

Thanks, the infections surprise me as high as they are... something I was absolutely worried about with the revision I had but thankfully did not occur.

[lasthope2.0]

Are these results from just the USA or worldwide?

Worldwide. Mostly from USA.
These are like vaccine adverse event reports. Everyone is supposed to report, but there may be events that can also go unreported or reported late.

Thanks, the infections surprise me as high as they are... something I was absolutely worried about with the revision I had but thankfully did not occur.

Glad it didn't occur. I was worried as well. Here are the list of countries that submitted events for Titan.