FDA Adverse Event
Injury
Summary report: N
LINEAGE TRANSCEND CERAMIC FEMORAL HEAD
MDR report key: 1052779
·
Received May 20, 2008
Report
- Report Number
- 1043534-2008-00114
- Event Type
- Injury
- Date Received
- May 20, 2008
- Date of Event
- January 20, 2005
- Report Date
- April 28, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LPH
- PMA / PMN Number
- K002149
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00113. THIS EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO RECURRENT DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINEAGE TRANSCEND CERAMIC FEMORAL HEAD | LPH | WRIGHT MEDICAL TECHNOLOGY, INC. | 101A147592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |