MAUDE manufacturer profile
EXACTECH, INC. · KWS
MAUDE profile for Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Key facts
| Manufacturer | EXACTECH, INC. |
|---|---|
| Manufacturer group | EXACTECH |
| Product code | KWS |
| Product code name | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
At a glance
- 1,000+ MAUDE reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Pain, Loosening of Implant Not Related to Bone-Ingrowth, Insufficient Information, Naturally Worn, No Code Available, Fracture, Failure of Implant 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