S3 · 06/2020 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 06/2020 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2020-00223 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
IT WAS REPORTED THAT THE PATIENT'S RIGHT MAKO PARTIAL KNEE WAS REVISED DUE TO MEDIAL SUBSIDENCE OF THE FEMORAL COMPONENT, SUBSIDENCE OF THE TIBIAL COMPONENT, AND EXTREME POLY WEAR. SURGEON STATED THE OPINION THAT POLY WEAR/ DEBRIS WAS A CAUSE OR CONTRIBUTOR FOR FEMORAL SUBSIDENCE
| 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 |