FDA Adverse Event
Injury
Summary report: N
LINEAGE TRANSCEND SUPERFINISHED FEMORAL HEAD
MDR report key: 1050230
·
Received May 22, 2008
Report
- Report Number
- 1043534-2008-00118
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- June 27, 2007
- Report Date
- April 28, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDL
- PMA / PMN Number
- K004043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. PRODUCT WAS NOT RETURNED FOR EVALUATION. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN A FOREIGN COUNTRY.
Description of Event or Problem · 1
ALLEGEDLY, COMPONENT WAS MISMATCHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINEAGE TRANSCEND SUPERFINISHED FEMORAL HEAD | JDL | WRIGHT MEDICAL TECHNOLOGY, INC. | 10526955 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |