FDA Adverse Event
Injury
Summary report: N
TRANSCEND QUADRANT SHELL
MDR report key: 1120807
·
Received August 15, 2008
Report
- Report Number
- 1043534-2008-00183
- Event Type
- Injury
- Date Received
- August 15, 2008
- Date of Event
- July 10, 2008
- Report Date
- August 1, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LZO
- PMA / PMN Number
- K004043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00184. THIS EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
ALLEGEDLY PATIENT REVISED DUE TO CUP/NECK IMPINGEMENT CAUSING EDGE LOADING. THE SHELL AND LINER WERE MANUFACTURED BY WRIGHT MEDICAL. THE STEM AND CERAMIC HEAD WERE MANUFACTURED BY MARGRON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSCEND QUADRANT SHELL | LZO | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 010A115559 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R |