S3 · 01/2021 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 01/2021 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2021-00009 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
REPORTED EVENT: AN EVENT REGARDING INSTABILITY (IMPLANT LOOSENING) INVOLVING AN UNKNOWN MAKO ROBOT/TKA APPLICATION SOFTWARE WAS REPORTED. THE EVENT WAS CONFIRMED THROUGH A CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS HOWEVER THE ROOT CAUSE WAS NOT ESTABLISHED AND AN ALLEGED F
| 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 |