MAUDE manufacturer profile
ZIMMER BIOMET, INC. · KWI
MAUDE profile for Prosthesis, Elbow, Hemi-, Radial, Polymer
Key facts
| Manufacturer | ZIMMER BIOMET, INC. |
|---|---|
| Manufacturer group | ZIMMER BIOMET, INC. |
| Product code | KWI |
| Product code name | Prosthesis, Elbow, Hemi-, Radial, Polymer |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Pain, Failure of Implant, No Information, Detachment of Device or Device Component, Insufficient Information, Loosening of Implant Not Related to Bone-Ingrowth, 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 manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1