S3 · 01/2024 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 01/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR MW5149922 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
REPORTER CALLING, STATING SHE HAS HAD NUMEROUS HEALTH PROBLEMS AFTER SHE WAS IMPLANTED WITH THE "BIOLOX" HIP FROM STRYKER "SOME TIME IN 2019". REPORTER STATES SHE LEARNED THAT HER IMPLANTED HIP SYSTEM WAS "RECALLED" AND SHE HAS CONCERNS THAT HER HEALTH PROBLEMS ARE DUE TO THIS. R
| 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 |