MAUDE manufacturer profile
ENCORE MEDICAL L.P. · KWS
MAUDE profile for Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Key facts
| Manufacturer | ENCORE MEDICAL L.P. |
|---|---|
| Manufacturer group | ENCORE MEDICAL L.P. |
| Product code | KWS |
| Product code name | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Unspecified Infection, No Code Available, Appropriate Term/Code Not Available, Joint Laxity, Joint Dislocation, Device Dislodged or Dislocated, Unstable 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