MAUDE manufacturer profile
MEDACTA INTERNATIONAL SA · KWS
MAUDE profile for Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Key facts
| Manufacturer | MEDACTA INTERNATIONAL SA |
|---|---|
| Manufacturer group | MEDACTA INTERNATIONAL SA |
| Product code | KWS |
| Product code name | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Pain, Appropriate Term/Code Not Available, Peri-prosthetic Joint Infection, Device Appears to Trigger Rejection, Implant Pain, 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