FDA Adverse Event
Injury
Summary report: N
C-STEM CDH
MDR report key: 560239
·
Received December 15, 2004
Report
- Report Number
- 1818910-2004-00916
- Event Type
- Injury
- Date Received
- December 15, 2004
- Report Date
- November 22, 2004
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- JDI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REVISION DUE TO FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-STEM CDH | TOTAL HIP REPLACEMENT | JDI | DEPUY INTERNATIONAL, LTD. | NA | WXV97 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |