MAUDE manufacturer profile
DEPUY IRELAND - 9616671 · OIY
MAUDE profile for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Key facts
| Manufacturer | DEPUY IRELAND - 9616671 |
|---|---|
| Manufacturer group | JTE RAYNHAM MFG SITE |
| Product code | OIY |
| Product code name | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Pain, Appropriate Term / Code Not Available, Joint Laxity, Adhesion(s), Loss of Range of Motion, Loss of or Failure to Bond, Muscular Rigidity 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