Titan MAUDE Updates - May 2026

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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.

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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).