S3 · 08/2020 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 08/2020 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2020-00287 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT. SURGEON REPORTED THAT THE DISTAL FEMUR METAPHYSIS LOOKED "DISINTEGRATED." PATIENT'S KNEE CONSTRUCT WAS REVISED TO A HINGED DISTAL FEMUR CONSTRUCT. REP CONFIRMED THERE ARE NO ALLEGA
| 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 |