MAUDE brand profile
GMKSPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 310 MM R ECROSS
MAUDE brand safety profile
Key facts
| Brand name | GMKSPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 310 MM R ECROSS |
|---|
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Problems coded
- 1–9 Problems flagged by Orca1 signal analytics
- Device Appears to Trigger Rejection, Unspecified Infection, Appropriate Term/Code Not Available, Adverse Event Without Identified Device or Use Problem, Joint Laxity, Pain 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