S3 · 03/2026 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 03/2026 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2026-00121 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT DURING A RIGHT MAKO TKA 2.0 PROCEDURE, THE PATIENT'S POPLITEAL ARTERY WAS NICKED. THE SURGEON DID EXTEND THE BOUNDARIES ON CUTS, BUT IT IS NOT KNOWN AT WHAT POINT DURING THE PROCEDURE THE ARTERY WAS NICKED. ISSUE WAS NO
| 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 |