S3 · 04/2024 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 04/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR MW5154366 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
DIAGNOSED WITH SEVERE ARTHRITIS IN LEFT KNEE AND HAD A TOTAL KNEE REPLACEMENT ON (B)(6) 2020. THE SURGEON USED THE STRYKER TRIATHLON AND MAKO NAVIGATION SYSTEM. I NEVER FULLY RECOVERED, AND HAD SEVERE INSTABILITY WITH EXTENSIVE PAIN AND SWELLING THAT WORSENED APPROXIMATELY 4 MONT
| Sev | Date | Company | Event |
|---|---|---|---|
| S2 | 2015-06-30 | Hocoma | Proximal tibia fracture in a patient with incomplete spinal cord injury associated with robotic treadmill training |