FDA Adverse Event
Injury
Summary report: N
DYNASTY(R) BF SHELL
MDR report key: 2072206
·
Received April 28, 2011
Report
- Report Number
- 1043534-2011-00174
- Event Type
- Injury
- Date Received
- April 28, 2011
- Date of Event
- March 17, 2011
- Report Date
- March 28, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- PMA / PMN Number
- K082924
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO DEVICE FAILURE. THE PRODUCT WAS VISUALLY EXAMINED. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE DEVICE HISTORY RECORD WAS ALSO REVIEWED.
Additional Manufacturer Narrative · 1
DEVICE #3:INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-0172, 00173.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO INSTABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DYNASTY(R) BF SHELL | HIP COMPONENT | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | 109920348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R |