MAUDE manufacturer profile
DEPUY INTERNATIONAL LTD - 8010379 · LZO
MAUDE profile for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Key facts
| Manufacturer | DEPUY INTERNATIONAL LTD - 8010379 |
|---|---|
| Manufacturer group | JTE WARSAW MFG SITE |
| Product code | LZO |
| Product code name | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Pain, Insufficient Information, Adverse Event Without Identified Device or Use Problem, No Code Available, Appropriate Term/Code Not Available, Host-Tissue Reaction, Inadequate Osseointegration, 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