S3 · 11/2020 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 11/2020 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR MW5097864 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
STRYKER REP DID NOT SHOW UP FOR CASE. A CEMENTLESS MAKO BILATERAL KNEE PLANNED AND ONLY THE MPS REP WAS PRESENT BECAUSE STRYKER JOINT REP WAS TOO BUSY TO COVER. A CEMENTED TKA IMPLANT WAS GIVEN BY REP AND IMPLANTED IN LEFT KNEE AND ONLY NOTED BY REP WHILE DOING INVENTORY WHEN RIG
| 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 |