S3 · 08/2025 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 08/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2025-00394 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
MPS REPORTED AN INCIDENT DURING A MAKO KNEE CASE, WHERE THE SURGEONS THOUGHT THAT BOTH FEMUR AND TIBIA CUT WERE INACCURATE. THE INCORRECT CUTTING FOR BOTH FEMUR AND TIBIA HAS RESULTED IN MALPOSITION OF IMPLANT, COMPROMISING THE KNEE STABILITY. THE SESSION FILE WILL BE UPLOADED NE
| 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 |