FDA Adverse Event
Injury
Summary report: N
LINEAGE PC QUAD HEMI FLR STD SHELL
MDR report key: 1052798
·
Received May 20, 2008
Report
- Report Number
- 1043534-2008-00095
- Event Type
- Injury
- Date Received
- May 20, 2008
- Date of Event
- January 25, 2005
- Report Date
- May 1, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LPH
- PMA / PMN Number
- K002149
- 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. TRENDS WILL BE EVALUATED. ADD'L INFO HAS BEEN REQUESTED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00092, 00093, 00094. THIS EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
ALLEGEDLY PT DISLOCATING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINEAGE PC QUAD HEMI FLR STD SHELL | LPH | WRIGHT MEDICAL TECHNOLOGY, INC. | 08490744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |