FDA Adverse Event
Injury
Summary report: N
ZIRCONIA
MDR report key: 1895516
·
Received November 10, 2010
Report
- Report Number
- 1020279-2010-00319
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- August 29, 2010
- Report Date
- October 10, 2010
- Manufacturer
- SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT REVISION SURGERY DUE TO A FRACTURE OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIRCONIA | FEMORAL HEAD | LZO | SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE | 02AM11337 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |