FDA Adverse Event
Injury
Summary report: N
NEXGEN LPS-FLEX GSF FEMORAL COMPONENT
MDR report key: 4092082
·
Received August 21, 2014
Report
- Report Number
- 1822565-2014-01024
- Event Type
- Injury
- Date Received
- August 21, 2014
- Date of Event
- March 20, 2013
- Report Date
- July 25, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN AND INSTABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504497 | NEXGEN LPS-FLEX GSF FEMORAL COMPONENT | JWH | ZIMMER, INC. | 61352491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |