MAUDE brand profile
GMKSPHERE TIBIAL INSERT FIXED FLEX SIZE 412 MM RIGHT
MAUDE brand safety profile
Key facts
| Brand name | GMKSPHERE TIBIAL INSERT FIXED FLEX SIZE 412 MM RIGHT |
|---|
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems coded
- 1–9 Problems flagged by Orca1 signal analytics
- Device Issue, Unstable, Positioning Problem, Difficult to Insert, Obstruction of Flow, Adverse Event Without Identified Device or Use Problem, Joint Disorder, Loss of Range of Motion Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1