MAUDE manufacturer profile
DEPUY IRELAND - 3015516266 · PKC
MAUDE profile for Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Key facts
| Manufacturer | DEPUY IRELAND - 3015516266 |
|---|---|
| Manufacturer group | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Product code | PKC |
| Product code name | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained |
At a glance
- 10–99 MAUDE 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, Joint Laxity, Insufficient Information, Unspecified Tissue Injury, Bone Fracture(s), Loss of or Failure to Bond, Use of Device Problem, Osseointegration Problem 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